Intraductal Papillary Mucinous Neoplasm of PancreasPhase 3RESCUENCT05914077
Aspiration of Duodenopancreatic Juice After Secretin Stimulation vs Endoscopic Aspiration for Molecular Analysis of Intraductal Papillary Mucinous Intraductal Neoplasia.
A Phase 3 study testing Secretin, Endoscopic aspiration and Endoscopic ultrasound-guided fine needle aspiration in people with Intraductal Papillary Mucinous Neoplasm of Pancreas, run by Fundacion Clinic per a la Recerca Biomédica at 1 site in Spain.
Trial summary
Study to evaluate aspiration of duodenopancreatic juice after secretin stimulation (ADPJ-secr)versus endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) for molecular analysis of intraductal papillary mucinous intraductal neoplasia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intraductal Papillary Mucinous Neoplasm of Pancreas
- What is being tested?
- Secretin, Endoscopic aspiration and Endoscopic ultrasound-guided fine needle aspiration
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteSpain
- Study dates
- 13 Sep 2023to Jan 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be a man or woman over 18 years of age.
- Willing to comply with the study procedures described in the protocol.
- Willing and able to give written informed consent.
- Meet at least one of the following three criteria in relation to the diagnosis or prognosis of IPMN:
- 4.1 Diagnosis of IMPN based on evidence of major criteria or existence of at least 2 minor criteria. Major criterion: Typical findings on MRI and/or EUS (single or multiple cysts with clear ductal communication and/or focal or diffuse dilatation # 5 mm in diameter of the main pancreatic duct without apparent obstructive cause). Minor criteria: a) Mucosecretory cells and/or extracellular mucin on cytological examination of intracystic fluid. b) Clear mucoid or filmy appearance of the intracystic fluid. c) Intracystic fluid CEA concentration >192 ng/mL or intracystic glucose < 50 mg/dL.
- 4.2 IPMN with cysts with a diameter # 10 mm and/or focal or diffuse dilatation of the main pancreatic duct with a diameter # 7 mm requiring EUS-FNA for diagnostic purposes or to assess risk or existence of malignancy following the main clinical practice guidelines.
- 4.3 IPMN with indication for surgical resection of the lesion.
- In case of a woman of childbearing age*, willing to use highly effective contraception or practice sexual abstinence from the screening visit until one week after undergoing the procedure under study. Highly effective contraceptive methods will include: combined oral, intravaginal or transdermal hormonal contraceptives (containing oestrogens and progestogens) associated with ovulation inhibition; oral, injectable or implantable progestogen-only hormonal contraception associated with ovulation inhibition; intrauterine device; intrauterine hormone-releasing system; bilateral tubal occlusion; vasectomised partner; and sexual abstinence. 6. If you are a woman of childbearing age, be willing to undergo a urine pregnancy test prior to inclusion in the study.
Who cannot join
- History of surgery that prevents endoscopic access to the major duodenal papilla in the case of ADPJ-secr, or to the area of the stomach or intestine from which to perform FNA.
- History of acute pancreatitis during the 30 days prior to inclusion.
- Pregnant women, women who may become pregnant during the month prior to inclusion or women who are breastfeeding.
- Coagulopathy (PT < 25%, INR > 1.5, platelets < 50,000/mL) preventing FNA.
- Renal failure with GFR < 30 mL/min or patients on dialysis.
- Known hypersensitivity to any component of the ChiRhoStim® (human secretin) formulation.
- Any clinically relevant medical condition that, in the opinion of the investigator, makes the patient unfit to participate in the study (underlying haematological disorders, autoimmune disease, immunodeficiency, gastrointestinal, psychiatric, renal, hepatic and cardiopulmonary disorders).
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Clínic de Barcelona
Barcelona, 08036
Àngels Ginès, MD
Àngels Ginès, MD
About this study
Official title: Aspiration of Duodenopancreatic Juice After Secretin Stimulation (ADPJ-secr-) vs Endoscopic Aspiration (EUS-FNA) for Molecular Analysis of Intraductal Papillary Mucinous Intraductal Neoplasia (IPMN).
Study to evaluate aspiration of duodenopancreatic juice after secretin stimulation (ADPJ-secr)versus endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) for molecular analysis of intraductal papillary mucinous intraductal neoplasia.
- Being tested
- Secretin, Endoscopic aspiration, Endoscopic ultrasound-guided fine needle aspiration
- Medical subject headings
- Pancreatic Intraductal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SecretinDrug
Secretin will be administered intravenous during 1 minute at a dose of 0,2 μg/Kg previous to the endoscopic procedure.
Endoscopic aspirationProcedure or surgery
Endoscopic aspiration of duodenopancreatic juice after secretin stimulation
Endoscopic ultrasound-guided fine needle aspirationProcedure or surgery
Endoscopic ultrasound-guided fine needle aspiration of intraductal papillary mucinous intraductal neoplasia (IPMN).
| Study group | Role | What they receive |
|---|---|---|
| Duodenopancreatic aspiration after secretin stimulation + EUS-FNA | Experimental | Duodenopancreatic aspiration after secretin stimulation will be performed followed by endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) Receives: Drug: Secretin; Procedure: Endoscopic aspiration; Procedure: Endoscopic ultrasound-guided fine needle aspiration |
| EUS-FNA + duodenopancreatic aspiration after secretin stimulation | Experimental | Endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) will be performed followed by duodenopancreatic aspiration after secretin stimulation Receives: Drug: Secretin; Procedure: Endoscopic aspiration; Procedure: Endoscopic ultrasound-guided fine needle aspiration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with IPMN with GNAS and KRAS mutations in intracystic fluid obtained by EUS-FNA versus pancreatic juice obtained by ADPJ-secr after both techniques.
In intracystic fluid obtained by EUS-FNA versus pancreatic juice obtained by ADPJ-secr after both techniques.
Measured: Through study completion, an average of 30 months
Secondary outcomes (46)
Proportion of patients with IPMN with Tp53 mutations.
In samples obtained by EUS-FNA versus ADPJ-secr after performing both techniques, in the subgroup of patients undergoing pancreatic resection within 12 months after study entry.
Measured: Through study completion, an average of 30 months
DNA concentration expressed in ng/µl
In samples obtained by EUS-FNA versus ADPJ-secr after performing both techniques.
Measured: Through study completion, an average of 30 months
Proportion of suitable samples obtained by the two techniques under study (ADPJ-secr and EUS-FNA) for molecular analysis.
A sample is defined as suitable when it is read by the Qubit fluorometer, which only detects full double-stranded DNA suitable for molecular analysis.
Measured: Through study completion, an average of 30 months
Proportion of patients undergoing pancreatic resection with a pathological diagnosis of IPMN who have mutations in GNAS and/or KRAS
In samples obtained by EUS-FNA versus ADPJ-secr within 12 months of study entry.
Measured: Through study completion, an average of 30 months
Proportion of patients undergoing pancreatic resection without a pathological diagnosis of IPMN who do not have GNAS and/or KRAS mutations
In samples obtained by EUS-FNA versus ADPJ-secr within 12 months of study entry.
Measured: Through study completion, an average of 30 months
Proportion of patients undergoing pancreatic resection with Tp53 mutations
In samples obtained by both techniques under study (ADPJ-secr vs EUS-FNA) who have advanced neoplasia in the surgical resection specimen after surgery performed within 12 months after study inclusion.
Advanced neoplasia is defined as the presence of IPMN with high-grade dysplasia or IMPN with associated invasive carcinoma according to Lokuhetty D, et al. Digestive SystemTumours: WHO Classification of Tumours, International Agency for Research on Cancer, 2019.
Measured: Through study completion, an average of 30 months
Proportion of patients undergoing pancreatic resection without Tp53 mutations.
In samples obtained by both techniques under study (ADPJ-secr vs EUS-FNA) who do not have advanced neoplasia in the surgical resection specimen after surgery performed within 12 months after inclusion in the study.
Advanced neoplasia is defined as the presence of IPMN with high-grade dysplasia or IPMN with associated invasive carcinoma according to Lokuhetty D, et al. Digestive System Tumours: WHO Classification of Tumours, International Agency for Research on Cancer, 2019.
Measured: Through study completion, an average of 30 months
To evaluate association between mutational status in the samples obtained by both techniques in relation to morphological characteristics of the lesion (diameter of the largest cystic lesion) obtained by EUS.
To compare if diameter of the largest cystic lesion in mm is different between both groups of study (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]).
Measured: Through study completion, an average of 30 months
To evaluate association between mutational status in the samples obtained by both techniques in relation to morphological characteristics of the lesion (maximum diameter of the main pancreatic duct) obtained by EUS.
To compare if median maximum diameter of the main pancreatic duct assessed by EUS and measured in mm is different between both groups of study (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]).
Measured: Through study completion, an average of 30 months
To evaluate association between mutational status in the samples obtained by both techniques in relation to morphological characteristics of the lesion (type of main pancreatic duct dilatation) obtained by EUS.
To compare if the proportion of patients that present a segmental main pancreatic duct dilatation assessed by EUS is different between both groups of study (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]).
Measured: Through study completion, an average of 30 months
To evaluate association between mutational status in the samples obtained by both techniques in relation to morphological characteristics of the lesion (location of the lesion) obtained by EUS.
To compare if the proportion of cystic lesions located in the pancreatic head, pancreatic body or pancreatic tail assessed by EUS are different between both groups of study (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]).
Measured: Through study completion, an average of 30 months
To evaluate association between mutational status in the samples obtained by both techniques in relation to morphological characteristics of the lesion (presence > 1 cystic lesion) obtained by EUS.
To compare if the proportion of patients with > 1 pancreatic cystic lesion assessed by EUS is different between both groups of study (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]).
Measured: Through study completion, an average of 30 months
To evaluate association between mutational status in the samples obtained by both techniques in relation to morphological characteristics of the lesion (mural nodules) obtained by EUS.
To compare if the proportion of patients that present mural nodules assessed by EUS is different between both groups of study (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]).
Measured: Through study completion, an average of 30 months
To evaluate association between mutational status in the samples obtained by both techniques in relation to morphological characteristics of the lesion (signs of chronic pancreatitis) obtained by EUS.
To compare if the proportion of patients that present features of chronic pancreatitis assessed by EUS is different between both groups of study (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]).
Measured: Through study completion, an average of 30 months
To evaluate association between mutational status in the samples obtained by both techniques in relation to morphological characteristics of the lesion (intraductal calcifications) obtained by EUS.
To compare if the proportion of patients that present intraductal calcifications assessed by EUS is different between both groups of study (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]).
Measured: Through study completion, an average of 30 months
To evaluate association between mutational status in the samples obtained by both techniques in relation to morphological characteristics of the lesion (pancreatic atrophy) obtained by EUS.
To compare if the proportion of patients that present pancreatic atrophy assessed by EUS is different between both groups of study (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]).
Measured: Through study completion, an average of 30 months
To evaluate association between mutational status (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]) in the samples obtained by both techniques under study (ADPJ-secr and EUS-FNA) in relation to age
To compare if median of age measured in years is different between both groups of study (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]).
Measured: Through study completion, an average of 30 months
To evaluate association between mutational status (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]) in the samples obtained by both techniques under study (ADPJ-secr and EUS-FNA) in relation to sex
To compare if the proportion of male or female patients are different between both groups of study (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]).
Measured: Through study completion, an average of 30 months
To evaluate association between mutational status (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]) in the samples obtained by both techniques under study (ADPJ-secr and EUS-FNA) in relation to smoking
To compare if the proportion of patients with reported active smoking is different between both groups of study (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]).
Measured: Through study completion, an average of 30 months
To evaluate association between mutational status (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]) in the samples obtained by both techniques under study (ADPJ-secr and EUS-FNA) in relation to chronic alcohol consumption
To compare if the proportion of patients with high risk chronic alcohol consumption (> 21 standard drinks for men, > 14 standard drinks for women) is different between both groups of study (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]).
Measured: Through study completion, an average of 30 months
To evaluate association between mutational status (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]) in the samples obtained by both techniques under study (ADPJ-secr and EUS-FNA) in relation to hypertension
To compare if the proportion of patients with hypertension is different between both groups of study (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]).
Measured: Through study completion, an average of 30 months
To evaluate association between mutational status (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]) in the samples obtained by both techniques under study (ADPJ-secr and EUS-FNA) in relation to type 2 diabetes mellitus
To compare if the proportion of patients with type 2 diabetes mellitus is different between both groups of study (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]).
Measured: Through study completion, an average of 30 months
To evaluate association between mutational status (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]) in the samples obtained by both techniques under study (ADPJ-secr and EUS-FNA) in relation to heart failure
To compare if the proportion of patients with chronic heart failure is different between both groups of study (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]).
Measured: Through study completion, an average of 30 months
To evaluate association between mutational status (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]) in the samples obtained by both techniques under study (ADPJ-secr and EUS-FNA) in relation to chronic liver disease.
To compare if the proportion of patients with chronic liver disease is different between both groups of study (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]).
Measured: Through study completion, an average of 30 months
To evaluate association between mutational status (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]) in the samples obtained by both techniques under study (ADPJ-secr and EUS-FNA) in relation to chronic kidney disease.
To compare if the proportion of patients with chronic kidney disease is different between both groups of study (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]).
Measured: Through study completion, an average of 30 months
To evaluate association between mutational status (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]) in the samples obtained by both techniques under study (ADPJ-secr and EUS-FNA) in relation to neoplasms.
To compare if the proportion of patients with previous neoplasm in past medical history is different between both groups of study (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]).
Measured: Through study completion, an average of 30 months
To evaluate association between mutational status (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]) in the samples obtained by both techniques under study (ADPJ-secr and EUS-FNA) in relation to history of acute pancreatitis
To compare if the proportion of patients with history of acute pancreatitis in past medical history is different between both groups of study (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]).
Measured: Through study completion, an average of 30 months
To evaluate association between mutational status (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]) in the samples obtained by both techniques under study (ADPJ-secr and EUS-FNA) in relation to previous diagnosis of chronic pancreatitis
To compare if the proportion of patients with history of chronic pancreatitis in past medical history is different between both groups of study (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]).
Measured: Through study completion, an average of 30 months
To evaluate association between mutational status (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]) in the samples obtained by both techniques under study (ADPJ-secr and EUS-FNA) in relation to family history (1st degree) of pancreatic cancer
To compare if the proportion of patients with history of pancreatic cancer in first degree relatives is different between both groups of study (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]).
Measured: Through study completion, an average of 30 months
To evaluate association between mutational status (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]) in the samples obtained by both techniques under study (ADPJ-secr and EUS-FNA) in relation to time since diagnosis of IPMN
To compare if time since diagnosis of IPMN measured in years is different between both groups of study (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]).
Measured: Through study completion, an average of 30 months
To evaluate association between mutational status (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]) in the samples obtained by both techniques under study (ADPJ-secr and EUS-FNA) in relation to morphological type of IPMN
To compare if the proportions of patients with MD-IPMN, BD-IPMN or mixed-type IPMN are different between both groups of study (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]).
Measured: Through study completion, an average of 30 months
To evaluate association between mutational status (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]) in the samples obtained by both techniques under study (ADPJ-secr and EUS-FNA) in relation to blood levels of amylase
To compare if mean blood levels of amylase measured in U/L is different between both groups of study (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]).
Measured: Through study completion, an average of 30 months
To evaluate association between mutational status (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]) in the samples obtained by both techniques under study (ADPJ-secr and EUS-FNA) in relation to blood levels of lipase
To compare if mean blood levels of lipase measured in U/L is different between both groups of study (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]).
Measured: Through study completion, an average of 30 months
To evaluate association between mutational status (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]) in the samples obtained by both techniques under study (ADPJ-secr and EUS-FNA) in relation to blood levels of creatinine
To compare if mean blood levels of creatinine measured in mg/dl is different between both groups of study (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]).
Measured: Through study completion, an average of 30 months
To evaluate association between mutational status (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]) in the samples obtained by both techniques under study (ADPJ-secr and EUS-FNA) in relation to blood levels of total bilirrubin
To compare if mean blood levels of total bilurrubin measured in mg/dl is different between both groups of study (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]).
Measured: Through study completion, an average of 30 months
To evaluate association between mutational status (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]) in the samples obtained by both techniques under study (ADPJ-secr and EUS-FNA) in relation to blood levels of AST
To compare if mean blood levels of AST measured in U/L is different between both groups of study (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]).
Measured: Through study completion, an average of 30 months
To evaluate association between mutational status (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]) in the samples obtained by both techniques under study (ADPJ-secr and EUS-FNA) in relation to blood levels of ALT (U/L)
To compare if mean blood levels of ALT measured in U/L is different between both groups of study (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]).
Measured: Through study completion, an average of 30 months
To evaluate association between mutational status (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]) in the samples obtained by both techniques under study (ADPJ-secr and EUS-FNA) in relation to blood levels of GGT (U/L)
To compare if mean blood levels of GGT measured in U/L is different between both groups of study (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]).
Measured: Through study completion, an average of 30 months
To evaluate association between mutational status (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]) in the samples obtained by both techniques under study (ADPJ-secr and EUS-FNA) in relation to blood levels of alkaline phosphatase (U/L)
To compare if mean blood levels of alkaline phosphatase measured in U/L is different between both groups of study (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]).
Measured: Through study completion, an average of 30 months
To evaluate association between mutational status (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]) in the samples obtained by both techniques under study (ADPJ-secr and EUS-FNA) in relation to blood levels of hemoglobin (g/L)
To compare if mean blood levels of hemoglobin measured in g/l is different between both groups of study (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]).
Measured: Through study completion, an average of 30 months
To evaluate association between mutational status (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]) in the samples obtained by both techniques under study (ADPJ-secr and EUS-FNA) in relation to blood levels of platelets (U/L)
To compare if mean blood total count of platelets measured in units per microliter is different between both groups of study (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]).
Measured: Through study completion, an average of 30 months
To evaluate association between mutational status (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]) in the samples obtained by both techniques under study (ADPJ-secr and EUS-FNA) in relation to blood levels of CA 19.9 (u/L)
To compare if mean blood levels of CA 19.9 measured in U/L is different between both groups of study (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]).
Measured: Through study completion, an average of 30 months
To evaluate association between mutational status (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]) in the samples obtained by both techniques under study (ADPJ-secr and EUS-FNA) in relation to blood levels of CEA (U/l)
To compare if mean blood levels of CEA measured in U/L is different between both groups of study (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]).
Measured: Through study completion, an average of 30 months
To evaluate association between mutational status (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]) in the samples obtained by both techniques under study (ADPJ-secr and EUS-FNA) in relation to blood levels of glycated hemoglobin.(%).
To compare if mean blood levels of glycated hemoglobin measured in % is different between both groups of study (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]).
Measured: Through study completion, an average of 30 months
To assess whether mutational status predicts the occurrence of adverse effects associated with the techniques under study at 24 hours and 7 days following the performance of the techniques under study.
To compare if the proportion of patients with adverse effects associated with the techniques under study at 24 hours and 7 days is different between both groups of study (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]). Adverse effects will be reported following the American Society of Gastrointestinal Endoscopy (ASGE) (P.B. Cotton, et al. Gastrointest Endosc, 2010) and the WHO Toxicity Grading Scale for Determining the Severity of Adverse Events, 2003.
Measured: Through study completion, an average of 30 months
Proportion of patients with Serious Adverse Events
Measured: At 24 hours and 7 days after the techniques under study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2023
- Study start13 Sep 2023
- Primary completionJan 2025 (estimated)
- Study completionJan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraductal Papillary Mucinous Neoplasm of PancreasStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacion Clinic per a la Recerca Biomédica
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05914077
- Sponsor's protocol ID
- 2022-002764-79
- Acronym
- RESCUE
- Status last verified
- Sep 2023
- First submitted
- 4 May 2023
- Last updated
- 18 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aspiration of Duodenopancreatic Juice After Secretin Stimulation (ADPJ-secr-) vs Endoscopic Aspiration (EUS-FNA) for Molecular Analysis of Intraductal Papillary Mucinous Intraductal Neoplasia (IPMN).
- ClinicalTrials.gov ID
- NCT05914077
- Acronym / sponsor ID
- RESCUE / 2022-002764-79
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Fundacion Clinic per a la Recerca BiomédicaUniversity, hospital or other
- Study start
- 13 Sep 2023 (actual)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 22 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study to evaluate aspiration of duodenopancreatic juice after secretin stimulation (ADPJ-secr)versus endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) for molecular analysis of intraductal papillary mucinous intraductal neoplasia.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Duodenopancreatic aspiration after secretin stimulation + EUS-FNA | Experimental | Drug: Secretin, Procedure: Endoscopic aspiration, Procedure: Endoscopic ultrasound-guided fine needle aspirationDuodenopancreatic aspiration after secretin stimulation will be performed followed by endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) |
| EUS-FNA + duodenopancreatic aspiration after secretin stimulation | Experimental | Drug: Secretin, Procedure: Endoscopic aspiration, Procedure: Endoscopic ultrasound-guided fine needle aspirationEndoscopic ultrasound-guided fine needle aspiration (EUS-FNA) will be performed followed by duodenopancreatic aspiration after secretin stimulation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Be a man or woman over 18 years of age.
- Willing to comply with the study procedures described in the protocol.
- Willing and able to give written informed consent.
- Meet at least one of the following three criteria in relation to the diagnosis or prognosis of IPMN:
- 4.1 Diagnosis of IMPN based on evidence of major criteria or existence of at least 2 minor criteria. Major criterion: Typical findings on MRI and/or EUS (single or multiple cysts with clear ductal communication and/or focal or diffuse dilatation # 5 mm in diameter of the main pancreatic duct without apparent obstructive cause). Minor criteria: a) Mucosecretory cells and/or extracellular mucin on cytological examination of intracystic fluid. b) Clear mucoid or filmy appearance of the intracystic fluid. c) Intracystic fluid CEA concentration >192 ng/mL or intracystic glucose < 50 mg/dL.
Key exclusion criteria (7 listed)
- History of surgery that prevents endoscopic access to the major duodenal papilla in the case of ADPJ-secr, or to the area of the stomach or intestine from which to perform FNA.
- History of acute pancreatitis during the 30 days prior to inclusion.
- Pregnant women, women who may become pregnant during the month prior to inclusion or women who are breastfeeding.
- Coagulopathy (PT < 25%, INR > 1.5, platelets < 50,000/mL) preventing FNA.
- Renal failure with GFR < 30 mL/min or patients on dialysis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SecretinSecretin will be administered intravenous during 1 minute at a dose of 0,2 μg/Kg previous to the endoscopic procedure. | Drug | Duodenopancreatic aspiration after secretin stimulation + EUS-FNA, EUS-FNA + duodenopancreatic aspiration after secretin stimulation |
| Endoscopic aspirationEndoscopic aspiration of duodenopancreatic juice after secretin stimulation | Procedure or surgery | Duodenopancreatic aspiration after secretin stimulation + EUS-FNA, EUS-FNA + duodenopancreatic aspiration after secretin stimulation |
| Endoscopic ultrasound-guided fine needle aspirationEndoscopic ultrasound-guided fine needle aspiration of intraductal papillary mucinous intraductal neoplasia (IPMN). | Procedure or surgery | Duodenopancreatic aspiration after secretin stimulation + EUS-FNA, EUS-FNA + duodenopancreatic aspiration after secretin stimulation |
Primary outcome
Proportion of patients with IPMN with GNAS and KRAS mutations in intracystic fluid obtained by EUS-FNA versus pancreatic juice obtained by ADPJ-secr after both techniques.
Time frame: Through study completion, an average of 30 months
In intracystic fluid obtained by EUS-FNA versus pancreatic juice obtained by ADPJ-secr after both techniques.
46 secondary outcomes
Proportion of patients with IPMN with Tp53 mutations.
Time frame: Through study completion, an average of 30 months
DNA concentration expressed in ng/µl
Time frame: Through study completion, an average of 30 months
Proportion of suitable samples obtained by the two techniques under study (ADPJ-secr and EUS-FNA) for molecular analysis.
Time frame: Through study completion, an average of 30 months
Proportion of patients undergoing pancreatic resection with a pathological diagnosis of IPMN who have mutations in GNAS and/or KRAS
Time frame: Through study completion, an average of 30 months
Proportion of patients undergoing pancreatic resection without a pathological diagnosis of IPMN who do not have GNAS and/or KRAS mutations
Time frame: Through study completion, an average of 30 months
Proportion of patients undergoing pancreatic resection with Tp53 mutations
Time frame: Through study completion, an average of 30 months
Proportion of patients undergoing pancreatic resection without Tp53 mutations.
Time frame: Through study completion, an average of 30 months
To evaluate association between mutational status in the samples obtained by both techniques in relation to morphological characteristics of the lesion (diameter of the largest cystic lesion) obtained by EUS.
Time frame: Through study completion, an average of 30 months
To evaluate association between mutational status in the samples obtained by both techniques in relation to morphological characteristics of the lesion (maximum diameter of the main pancreatic duct) obtained by EUS.
Time frame: Through study completion, an average of 30 months
To evaluate association between mutational status in the samples obtained by both techniques in relation to morphological characteristics of the lesion (type of main pancreatic duct dilatation) obtained by EUS.
Time frame: Through study completion, an average of 30 months
To evaluate association between mutational status in the samples obtained by both techniques in relation to morphological characteristics of the lesion (location of the lesion) obtained by EUS.
Time frame: Through study completion, an average of 30 months
To evaluate association between mutational status in the samples obtained by both techniques in relation to morphological characteristics of the lesion (presence > 1 cystic lesion) obtained by EUS.
Time frame: Through study completion, an average of 30 months
To evaluate association between mutational status in the samples obtained by both techniques in relation to morphological characteristics of the lesion (mural nodules) obtained by EUS.
Time frame: Through study completion, an average of 30 months
To evaluate association between mutational status in the samples obtained by both techniques in relation to morphological characteristics of the lesion (signs of chronic pancreatitis) obtained by EUS.
Time frame: Through study completion, an average of 30 months
To evaluate association between mutational status in the samples obtained by both techniques in relation to morphological characteristics of the lesion (intraductal calcifications) obtained by EUS.
Time frame: Through study completion, an average of 30 months
To evaluate association between mutational status in the samples obtained by both techniques in relation to morphological characteristics of the lesion (pancreatic atrophy) obtained by EUS.
Time frame: Through study completion, an average of 30 months
To evaluate association between mutational status (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]) in the samples obtained by both techniques under study (ADPJ-secr and EUS-FNA) in relation to age
Time frame: Through study completion, an average of 30 months
To evaluate association between mutational status (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]) in the samples obtained by both techniques under study (ADPJ-secr and EUS-FNA) in relation to sex
Time frame: Through study completion, an average of 30 months
To evaluate association between mutational status (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]) in the samples obtained by both techniques under study (ADPJ-secr and EUS-FNA) in relation to smoking
Time frame: Through study completion, an average of 30 months
To evaluate association between mutational status (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]) in the samples obtained by both techniques under study (ADPJ-secr and EUS-FNA) in relation to chronic alcohol consumption
Time frame: Through study completion, an average of 30 months
To evaluate association between mutational status (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]) in the samples obtained by both techniques under study (ADPJ-secr and EUS-FNA) in relation to hypertension
Time frame: Through study completion, an average of 30 months
To evaluate association between mutational status (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]) in the samples obtained by both techniques under study (ADPJ-secr and EUS-FNA) in relation to type 2 diabetes mellitus
Time frame: Through study completion, an average of 30 months
To evaluate association between mutational status (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]) in the samples obtained by both techniques under study (ADPJ-secr and EUS-FNA) in relation to heart failure
Time frame: Through study completion, an average of 30 months
To evaluate association between mutational status (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]) in the samples obtained by both techniques under study (ADPJ-secr and EUS-FNA) in relation to chronic liver disease.
Time frame: Through study completion, an average of 30 months
To evaluate association between mutational status (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]) in the samples obtained by both techniques under study (ADPJ-secr and EUS-FNA) in relation to chronic kidney disease.
Time frame: Through study completion, an average of 30 months
To evaluate association between mutational status (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]) in the samples obtained by both techniques under study (ADPJ-secr and EUS-FNA) in relation to neoplasms.
Time frame: Through study completion, an average of 30 months
To evaluate association between mutational status (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]) in the samples obtained by both techniques under study (ADPJ-secr and EUS-FNA) in relation to history of acute pancreatitis
Time frame: Through study completion, an average of 30 months
To evaluate association between mutational status (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]) in the samples obtained by both techniques under study (ADPJ-secr and EUS-FNA) in relation to previous diagnosis of chronic pancreatitis
Time frame: Through study completion, an average of 30 months
To evaluate association between mutational status (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]) in the samples obtained by both techniques under study (ADPJ-secr and EUS-FNA) in relation to family history (1st degree) of pancreatic cancer
Time frame: Through study completion, an average of 30 months
To evaluate association between mutational status (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]) in the samples obtained by both techniques under study (ADPJ-secr and EUS-FNA) in relation to time since diagnosis of IPMN
Time frame: Through study completion, an average of 30 months
To evaluate association between mutational status (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]) in the samples obtained by both techniques under study (ADPJ-secr and EUS-FNA) in relation to morphological type of IPMN
Time frame: Through study completion, an average of 30 months
To evaluate association between mutational status (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]) in the samples obtained by both techniques under study (ADPJ-secr and EUS-FNA) in relation to blood levels of amylase
Time frame: Through study completion, an average of 30 months
To evaluate association between mutational status (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]) in the samples obtained by both techniques under study (ADPJ-secr and EUS-FNA) in relation to blood levels of lipase
Time frame: Through study completion, an average of 30 months
To evaluate association between mutational status (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]) in the samples obtained by both techniques under study (ADPJ-secr and EUS-FNA) in relation to blood levels of creatinine
Time frame: Through study completion, an average of 30 months
To evaluate association between mutational status (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]) in the samples obtained by both techniques under study (ADPJ-secr and EUS-FNA) in relation to blood levels of total bilirrubin
Time frame: Through study completion, an average of 30 months
To evaluate association between mutational status (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]) in the samples obtained by both techniques under study (ADPJ-secr and EUS-FNA) in relation to blood levels of AST
Time frame: Through study completion, an average of 30 months
To evaluate association between mutational status (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]) in the samples obtained by both techniques under study (ADPJ-secr and EUS-FNA) in relation to blood levels of ALT (U/L)
Time frame: Through study completion, an average of 30 months
To evaluate association between mutational status (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]) in the samples obtained by both techniques under study (ADPJ-secr and EUS-FNA) in relation to blood levels of GGT (U/L)
Time frame: Through study completion, an average of 30 months
To evaluate association between mutational status (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]) in the samples obtained by both techniques under study (ADPJ-secr and EUS-FNA) in relation to blood levels of alkaline phosphatase (U/L)
Time frame: Through study completion, an average of 30 months
To evaluate association between mutational status (mutated GNAS/KRAS versus non-mutated GNAS/KRAS [wild type]) in the samples obtained by both techniques under study (ADPJ-secr and EUS-FNA) in relation to blood levels of hemoglobin (g/L)
Time frame: Through study completion, an average of 30 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Secretin, Endoscopic aspiration and Endoscopic ultrasound-guided fine needle aspiration in people with Intraductal Papillary Mucinous Neoplasm of Pancreas, run by Fundacion Clinic per a la Recerca Biomédica at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Àngels Ginès (+34.93.227.54.00 ext. 3121, magines@clinic.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with IPMN with GNAS and KRAS mutations in intracystic fluid obtained by EUS-FNA versus pancreatic juice obtained by ADPJ-secr after both techniques. (time frame: Through study completion, an average of 30 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2023.