Biopsy, Fine-NeedleNCT04164017
Impact of Suction in the EUS-guided Fine Needle Biopsy of Solid Pancreatic Lesions
A study testing EUS-guided FNB with Syringe Suction and EUS-guided FNB without Syringe Suction in people with Biopsy, Fine-Needle and Endosonography, run by Centro Hospitalar De São João, E.P.E. at 1 site in Portugal.
Trial summary
Tissue acquisition by Endoscopic Ultrasound (EUS) has become a modality of diagnosis and clinical orientation for several diseases. Although tissue acquisition traditionally involves the cytological diagnosis (using fine-needle aspiration/FNA), the importance of obtaining a core for histological examination (by… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Biopsy, Fine-Needle, Endosonography, Pancreatic Neoplasm
- What is being tested?
- EUS-guided FNB with Syringe Suction and EUS-guided FNB without Syringe Suction
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Jun 2019to 1 Apr 2020
- Phase
- Interventional
- 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
- Patients with 18 years of age and older;
- Ability to provide free and informed consent before entering the study;
- Imaging diagnosis of a solid pancreatic lesion that was proposed for EUS characterization;
- Presence of sectional imaging method (CT/MRI) performed within six months before randomization;
- Blood test (blood count and coagulation studies) compatible with the performance of invasive maneuvers;
- Clinical indication by the endoscopist for EUS-tissue acquisition with the use of an FNB needle.
Who cannot join
- Failure to provide free and informed consent;
- Clinically significant change in haemostasis laboratory parameters: International Normalized Ratio (INR) > 1.5; activated partial thromboplastin time (aPTT)> 50 seconds; Platelets <50,000;
- Absence of a proper anticoagulant and/or anti-aggregate therapy discontinuation for the performance of FNB;
- Absence of fasting (2h without clear liquids and 6h without solid foods);
- Clinical suspicion of upper digestive tract obstruction;
- An episode of acute pancreatitis within four weeks before echoendoscopy;
- Respiratory failure or hemodynamic instability;
- Pregnancy or breast-feeding.
Trial locations and contacts
1 site in 1 country.
Portugal1 site, 1 recruiting
- Recruiting
Centro Hospitalar São João
Porto, 4200-319
Pedro Costa-Moreira, +351913543173, pedromoreira.med@gmail.com
About this study
Official title: Comparative Evaluation of the Diagnostic Yield and Sample Quality in Endoscopic Ultrasound(EUS)-Guided Fine Needle Biopsy(FNB) of Pancreatic Solid Lesions With and Without Syringe Suction
Tissue acquisition by Endoscopic Ultrasound (EUS) has become a modality of diagnosis and clinical orientation for several diseases. Although tissue acquisition traditionally involves the cytological diagnosis (using fine-needle aspiration/FNA), the importance of obtaining a core for histological examination (by fine-needle biopsy/FNB) has recently been recognized.
Currently, there is no clear establishment of the usefulness of syringe suction for the diagnostic accuracy of solid pancreatic lesions when FNB is used.
Read more
Because of that, the investigators aimed to compare sensitivity, sample adequacy, and diagnostic yield of solid pancreatic lesions EUS-guided sampling using with and without syringe suction.
The study will be conducted on a consecutive sample of patients proposed to perform EUS for solid pancreatic lesions characterization, in which the clinical and imaging findings justify the need for an FNB.
For each case, FNB will be performed using two punctures: one with 20mL syringe suction, and another without suction. The order in which they will be performed will be known only by the performing physician and the nursing team at the time that FNB is proposed. This information will be concealed from the pathologist responsible for sample analysis.
Clinical care during and after the procedure will follow the existing guidelines.
Participants will undergo a single clinical evaluation (at the time of endoscopy and recovery) without the need for follow-up visits.
- Conditions
- Biopsy, Fine-Needle, Endosonography, Pancreatic Neoplasm
- Being tested
- EUS-guided FNB with Syringe Suction, EUS-guided FNB without Syringe Suction
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EUS-guided FNB with Syringe SuctionDevice
For each case, FNB will be performed using two punctures: one with 20mL syringe suction and another without aspiration. The order in which they will be performed will be known only by the performing physician and the nursing team at the time that FNB is proposed. This information will be concealed from the pathologist responsible for sample analysis.
EUS-guided FNB without Syringe SuctionDevice
For each case, FNB will be performed using two punctures: one with 20mL syringe suction and another without aspiration. The order in which they will be performed will be known only by the performing physician and the nursing team at the time that FNB is proposed. This information will be concealed from the pathologist responsible for sample analysis.
| Study group | Role | What they receive |
|---|---|---|
| EUS-guided FNB with syringe suction | Experimental | Not described Receives: Device: EUS-guided FNB with Syringe Suction |
| EUS-guided FNB without syringe suction | Active comparator | Not described Receives: Device: EUS-guided FNB without Syringe Suction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic Yield
Percentage of the lesions sampled for which a tissue diagnosis is obtained and specimen adequacy is defined as the percentage of lesions sampled in which the obtained material is representative of the target site and sufficient for diagnosis
Measured: Through study completion, an average of 10 months
Accuracy
Percentage of lesions sampled by EUS-tissue aquisition techniques that correspond to the final diagnosis at surgical histopathology or clinical follow-up (at least 12 months) for patients with nondiagnostic sampling.
Measured: Through study completion, an average of 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2019
- Study start1 Jun 2019
- Primary completion1 Apr 2020 (estimated)
- Study completion1 Apr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Biopsy, Fine-NeedleStudies 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centro Hospitalar De São João, E.P.E.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pedro Costa Moreira, Centro Hospitalar De São João, E.P.E.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04164017
- Sponsor's protocol ID
- 77/19
- Status last verified
- Nov 2019
- First submitted
- 12 Nov 2019
- Last updated
- 15 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wani S, Muthusamy VR, McGrath CM, Sepulveda AR, Das A, Messersmith W, Kochman ML, Shah J. AGA White Paper: Optimizing Endoscopic Ultrasound-Guided Tissue Acquisition and Future Directions. Clin Gastroenterol Hepatol. 2018 Mar;16(3):318-327. doi: 10.1016/j.cgh.2017.10.020. Epub 2017 Oct 23. No abstract available.
PubMed 29074447Wani S, Muthusamy VR, Komanduri S. EUS-guided tissue acquisition: an evidence-based approach (with videos). Gastrointest Endosc. 2014 Dec;80(6):939-59.e7. doi: 10.1016/j.gie.2014.07.066. No abstract available.
PubMed 25434654Dwyer J, Pantanowitz L, Ohori NP, Pai RK, Vrbin C, Brand RE, Monaco SE. Endoscopic ultrasound-guided FNA and ProCore biopsy in sampling pancreatic and intra-abdominal masses. Cancer Cytopathol. 2016 Feb;124(2):110-21. doi: 10.1002/cncy.21623. Epub 2015 Oct 2.
PubMed 26430767Lee JK, Choi JH, Lee KH, Kim KM, Shin JU, Lee JK, Lee KT, Jang KT. A prospective, comparative trial to optimize sampling techniques in EUS-guided FNA of solid pancreatic masses. Gastrointest Endosc. 2013 May;77(5):745-51. doi: 10.1016/j.gie.2012.12.009. Epub 2013 Feb 21.
PubMed 23433878Wallace MB, Kennedy T, Durkalski V, Eloubeidi MA, Etamad R, Matsuda K, Lewin D, Van Velse A, Hennesey W, Hawes RH, Hoffman BJ. Randomized controlled trial of EUS-guided fine needle aspiration techniques for the detection of malignant lymphadenopathy. Gastrointest Endosc. 2001 Oct;54(4):441-7. doi: 10.1067/mge.2001.117764.
PubMed 11577304
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of the Diagnostic Yield and Sample Quality in Endoscopic Ultrasound(EUS)-Guided Fine Needle Biopsy(FNB) of Pancreatic Solid Lesions With and Without Syringe Suction
- ClinicalTrials.gov ID
- NCT04164017
- Acronym / sponsor ID
- 77/19
- Conditions
- Biopsy, Fine-Needle, Endosonography, Pancreatic Neoplasm
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Centro Hospitalar De São João, E.P.E.University, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 1 Apr 2020 (estimated)
- Study completion
- 1 Apr 2020 (estimated)
- First posted
- 15 Nov 2019 (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.
Tissue acquisition by Endoscopic Ultrasound (EUS) has become a modality of diagnosis and clinical orientation for several diseases. Although tissue acquisition traditionally involves the cytological diagnosis (using fine-needle aspiration/FNA), the importance of obtaining a core for histological examination (by fine-needle biopsy/FNB) has recently been recognized.
Currently, there is no clear establishment of the usefulness of syringe suction for the diagnostic accuracy of solid pancreatic lesions when FNB is used.
Because of that, the investigators aimed to compare sensitivity, sample adequacy, and diagnostic yield of solid pancreatic lesions EUS-guided sampling using with and without syringe suction.
The study will be conducted on a consecutive sample of patients proposed to perform EUS for solid pancreatic lesions characterization, in which the clinical and imaging findings justify the need for an FNB.
For each case, FNB will be performed using two punctures: one with 20mL syringe suction, and another without suction. The order in which they will be performed will be known only by the performing physician and the nursing team at the time that FNB is proposed. This information will be concealed from the pathologist responsible for sample analysis.
Clinical care during and after the procedure will follow the existing guidelines.
Participants will undergo a single clinical evaluation (at the time of endoscopy and recovery) without the need for follow-up visits.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EUS-guided FNB with syringe suction | Experimental | Device: EUS-guided FNB with Syringe Suction |
| EUS-guided FNB without syringe suction | Active comparator | Device: EUS-guided FNB without Syringe Suction |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with 18 years of age and older;
- Ability to provide free and informed consent before entering the study;
- Imaging diagnosis of a solid pancreatic lesion that was proposed for EUS characterization;
- Presence of sectional imaging method (CT/MRI) performed within six months before randomization;
- Blood test (blood count and coagulation studies) compatible with the performance of invasive maneuvers;
Key exclusion criteria (8 listed)
- Failure to provide free and informed consent;
- Clinically significant change in haemostasis laboratory parameters: International Normalized Ratio (INR) > 1.5; activated partial thromboplastin time (aPTT)> 50 seconds; Platelets <50,000;
- Absence of a proper anticoagulant and/or anti-aggregate therapy discontinuation for the performance of FNB;
- Absence of fasting (2h without clear liquids and 6h without solid foods);
- Clinical suspicion of upper digestive tract obstruction;
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 |
|---|---|---|
| EUS-guided FNB with Syringe SuctionFor each case, FNB will be performed using two punctures: one with 20mL syringe suction and another without aspiration. The order in which they will be performed will be known only by the performing physician and the nursing team at the time that FNB is proposed. This information will be concealed from the pathologist responsible for sample analysis. | Device | EUS-guided FNB with syringe suction |
| EUS-guided FNB without Syringe SuctionFor each case, FNB will be performed using two punctures: one with 20mL syringe suction and another without aspiration. The order in which they will be performed will be known only by the performing physician and the nursing team at the time that FNB is proposed. This information will be concealed from the pathologist responsible for sample analysis. | Device | EUS-guided FNB without syringe suction |
Primary outcome
Diagnostic Yield
Time frame: Through study completion, an average of 10 months
Percentage of the lesions sampled for which a tissue diagnosis is obtained and specimen adequacy is defined as the percentage of lesions sampled in which the obtained material is representative of the target site and sufficient for diagnosis
Accuracy
Time frame: Through study completion, an average of 10 months
Percentage of lesions sampled by EUS-tissue aquisition techniques that correspond to the final diagnosis at surgical histopathology or clinical follow-up (at least 12 months) for patients with nondiagnostic sampling.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2019.
- Background: PubMed 29074447Wani S, Muthusamy VR, McGrath CM, Sepulveda AR, Das A, Messersmith W, Kochman ML, Shah J. AGA White Paper: Optimizing Endoscopic Ultrasound-Guided Tissue Acquisition and Future Directions. Clin Gastroenterol Hepatol. 2018 Mar;16(3):318-327. doi: 10.1016/j.cgh.2017.10.020. Epub 2017 Oct 23. No abstract available.
- Background: PubMed 25434654Wani S, Muthusamy VR, Komanduri S. EUS-guided tissue acquisition: an evidence-based approach (with videos). Gastrointest Endosc. 2014 Dec;80(6):939-59.e7. doi: 10.1016/j.gie.2014.07.066. No abstract available.
- Background: PubMed 26430767Dwyer J, Pantanowitz L, Ohori NP, Pai RK, Vrbin C, Brand RE, Monaco SE. Endoscopic ultrasound-guided FNA and ProCore biopsy in sampling pancreatic and intra-abdominal masses. Cancer Cytopathol. 2016 Feb;124(2):110-21. doi: 10.1002/cncy.21623. Epub 2015 Oct 2.
- Background: PubMed 23433878Lee JK, Choi JH, Lee KH, Kim KM, Shin JU, Lee JK, Lee KT, Jang KT. A prospective, comparative trial to optimize sampling techniques in EUS-guided FNA of solid pancreatic masses. Gastrointest Endosc. 2013 May;77(5):745-51. doi: 10.1016/j.gie.2012.12.009. Epub 2013 Feb 21.
- Background: PubMed 11577304Wallace MB, Kennedy T, Durkalski V, Eloubeidi MA, Etamad R, Matsuda K, Lewin D, Van Velse A, Hennesey W, Hawes RH, Hoffman BJ. Randomized controlled trial of EUS-guided fine needle aspiration techniques for the detection of malignant lymphadenopathy. Gastrointest Endosc. 2001 Oct;54(4):441-7. doi: 10.1067/mge.2001.117764.
- Individual participant dataSharing planned: No
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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 study testing EUS-guided FNB with Syringe Suction and EUS-guided FNB without Syringe Suction in people with Biopsy, Fine-Needle and Endosonography, run by Centro Hospitalar De São João, E.P.E. at 1 site in Portugal.
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 6 inclusion and 8 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 15 Nov 2019. 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 Portugal. 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.
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 Pedro Costa-Moreira (+351913543173, pedromoreira.med@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic Yield (time frame: Through study completion, an average of 10 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04164017, which also lists 5 linked publications.
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 15 Nov 2019.