Cystic Tumors of PancreasNCT03182270
Clinical Evaluation Of Needle-based Confocal Laser Endomicroscopy in Cystic Tumors of the Pancreas
A study testing nCLE in people with Cystic Tumors of Pancreas, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
This study focuses on pancreatic cysts, especially malignant pancreatic cysts. The primary hypothesis of the study is that using nCLE in addition to EUS-FNA and tissue sampling allows better characterization of pancreatic cysts and improves appropriate therapeutic decision-making. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cystic Tumors of Pancreas
- What is being tested?
- nCLE
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- Jul 2016to Dec 2021
- 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
- Male or female > 18 years of age.
- Patient indicated for a first EUS-FNA for a pancreatic cyst or
- Patients who had previous non-diagnostic tissue sampling taken during a previous EUS-FNA for pancreatic cyst more than three months ago.
- Patient with known pancreatic cyst detected at cross-sectional imaging
- Willing and able to comply with study procedures and provide written informed consent to participate in the study.
Who cannot join
- Subjects for whom EUS-FNA procedures are contraindicated
- Known allergy to fluorescein dye
- If female, pregnant based on a positive hCG serum or an in vitro diagnostic test result or breast-feeding
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Aiming Yang, M.D., +86-10-69151593, yangaiming@medmail.com.cn
About this study
This study focuses on pancreatic cysts, especially malignant pancreatic cysts. The primary hypothesis of the study is that using nCLE in addition to EUS-FNA and tissue sampling allows better characterization of pancreatic cysts and improves appropriate therapeutic decision-making. For physicians, integrating nCLE into the diagnostic algorithm of pancreatic cysts could impact patient management by: Ruling out malignancy for patients with benign appearing nCLE images. Characterizing more malignant tumors in the pancreas.
Read the detailed description
- Medical background: Pancreatic cysts are quite rare, but are being increasingly recognized due to the expanding use of cross-sectional imaging. They are classified into three main classes: pseudocysts, serous cysts and mucinous cystic neoplasms. Either intraductal papillary mucinous neoplasm (IPMN) or mucinous cyst adenomas / mucinous cystadenocarcinoma(MCN) Mucinous cystic neoplasms are considered to be malignant or pre-malignant and are considered for surgical resection, whereas pseudocysts and serous cysts are considered benign and with a low potential for malignancy. Pseudocysts and serous cysts are usually only considered for surgical resection when symptomatic or enlarging.
- Clinical background: 2.1. Endoscopic Ultrasound (EUS) is the diagnostic method of choice when a pancreatic lesion is found incidentally on cross-sectional imaging. Endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) is a procedure where a target tissue in proximity to the GI tract is biopsied using a fine needle guided in real time by an ultrasound probe fixed at the tip of an endoscope. It may therefore be applied to pancreatic lesions, or lymph nodes examination. 2.2. The principle of needle-based Confocal Laser Endomicroscopy (nCLE) is to image organs within or adjacent to the GI tracts with a miniprobe inserted through an endoscopic needle. The fundamental technology as well as the principle of operation of nCLE are substantially similar to pCLE.
- Clinical evidence: Previous studies enabled to define interpretation criteria on the micro-structure of benign pancreatic cysts. Less data is available on malignant pancreatic cysts, except for a few images done in a pilot study of identification of pancreatic cystic neoplasms.
- Objectives: 4.1 The primary objective of the study is to assess the diagnostic performance of the Cellvizio nCLE system in diagnosing pancreatic cysts, when associated with other diagnostic information. 4.2 The secondary objectives are to assess the potential impact of the Cellvizio nCLE system on patient management and validate the interpretation classification criteria that were created during the previous studies.
- Design:
This study will be conducted in a single center in China.
- Conditions
- Cystic Tumors of Pancreas
- Being tested
- nCLE
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nCLEDiagnostic test
Procedure: EUS-FNA Device: nCLE
| Study group | Role | What they receive |
|---|---|---|
| pancreatic cysts | Experimental | Not described Receives: Diagnostic Test: nCLE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic performance of the Cellvizio nCLE system in the characterization of pancreatic cysts
Diagnostic performance of the Cellvizio nCLE system compared with pathological results or consensus review at a multidisciplinary tumor board meeting
Measured: Within 6 months after the end of Follow-up period
Secondary outcomes (2)
Safety data on nCLE during EUS-FNA procedure (rate of procedure related complication)
The rate of procedure related complication including bleeding, post-procedure pancreatitis and perforation
Measured: Within 3 months after the end of the enrollment period
Feasibility data on nCLE during EUS-FNA procedure (rate of successful nCLE procedure)
The rate of successful nCLE procedure
Measured: Within 3 months after the end of the enrollment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2017
- Study startJul 2016
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic Tumors of PancreasStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aiming Yang, M.D., Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03182270
- Sponsor's protocol ID
- ZS-1265
- Status last verified
- Jun 2020
- First submitted
- 19 May 2017
- Last updated
- 14 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation Of Needle-based Confocal Laser Endomicroscopy in Cystic Tumors of the Pancreas
- ClinicalTrials.gov ID
- NCT03182270
- Acronym / sponsor ID
- ZS-1265
- Conditions
- Cystic Tumors of Pancreas
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- Jul 2016 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 9 Jun 2017 (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.
This study focuses on pancreatic cysts, especially malignant pancreatic cysts. The primary hypothesis of the study is that using nCLE in addition to EUS-FNA and tissue sampling allows better characterization of pancreatic cysts and improves appropriate therapeutic decision-making. For physicians, integrating nCLE into the diagnostic algorithm of pancreatic cysts could impact patient management by: Ruling out malignancy for patients with benign appearing nCLE images. Characterizing more malignant tumors in the pancreas.
Detailed description
- Medical background: Pancreatic cysts are quite rare, but are being increasingly recognized due to the expanding use of cross-sectional imaging. They are classified into three main classes: pseudocysts, serous cysts and mucinous cystic neoplasms. Either intraductal papillary mucinous neoplasm (IPMN) or mucinous cyst adenomas / mucinous cystadenocarcinoma(MCN) Mucinous cystic neoplasms are considered to be malignant or pre-malignant and are considered for surgical resection, whereas pseudocysts and serous cysts are considered benign and with a low potential for malignancy. Pseudocysts and serous cysts are usually only considered for surgical resection when symptomatic or enlarging.
- Clinical background: 2.1. Endoscopic Ultrasound (EUS) is the diagnostic method of choice when a pancreatic lesion is found incidentally on cross-sectional imaging. Endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) is a procedure where a target tissue in proximity to the GI tract is biopsied using a fine needle guided in real time by an ultrasound probe fixed at the tip of an endoscope. It may therefore be applied to pancreatic lesions, or lymph nodes examination. 2.2. The principle of needle-based Confocal Laser Endomicroscopy (nCLE) is to image organs within or adjacent to the GI tracts with a miniprobe inserted through an endoscopic needle. The fundamental technology as well as the principle of operation of nCLE are substantially similar to pCLE.
- Clinical evidence: Previous studies enabled to define interpretation criteria on the micro-structure of benign pancreatic cysts. Less data is available on malignant pancreatic cysts, except for a few images done in a pilot study of identification of pancreatic cystic neoplasms.
- Objectives: 4.1 The primary objective of the study is to assess the diagnostic performance of the Cellvizio nCLE system in diagnosing pancreatic cysts, when associated with other diagnostic information. 4.2 The secondary objectives are to assess the potential impact of the Cellvizio nCLE system on patient management and validate the interpretation classification criteria that were created during the previous studies.
- Design:
This study will be conducted in a single center in China.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pancreatic cysts | Experimental | Diagnostic Test: nCLE |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female > 18 years of age.
- Patient indicated for a first EUS-FNA for a pancreatic cyst or
- Patients who had previous non-diagnostic tissue sampling taken during a previous EUS-FNA for pancreatic cyst more than three months ago.
- Patient with known pancreatic cyst detected at cross-sectional imaging
- Willing and able to comply with study procedures and provide written informed consent to participate in the study.
Key exclusion criteria (3 listed)
- Subjects for whom EUS-FNA procedures are contraindicated
- Known allergy to fluorescein dye
- If female, pregnant based on a positive hCG serum or an in vitro diagnostic test result or breast-feeding
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 |
|---|---|---|
| nCLEProcedure: EUS-FNA Device: nCLE | Diagnostic test | pancreatic cysts |
Primary outcome
Diagnostic performance of the Cellvizio nCLE system in the characterization of pancreatic cysts
Time frame: Within 6 months after the end of Follow-up period
Diagnostic performance of the Cellvizio nCLE system compared with pathological results or consensus review at a multidisciplinary tumor board meeting
2 secondary outcomes
Safety data on nCLE during EUS-FNA procedure (rate of procedure related complication)
Time frame: Within 3 months after the end of the enrollment period
Feasibility data on nCLE during EUS-FNA procedure (rate of successful nCLE procedure)
Time frame: Within 3 months after the end of the enrollment period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2020.
- Individual participant dataSharing planned: Undecided
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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.
Aiming Yang, M.D. principal investigator
Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nCLE in people with Cystic Tumors of Pancreas, run by Peking Union Medical College Hospital at 1 site in China.
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 5 inclusion and 3 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 14 Jul 2020. 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 China. 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 Aiming Yang, M.D. (+86-010-69151593, yangaiming@medmail.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic performance of the Cellvizio nCLE system in the characterization of pancreatic cysts (time frame: Within 6 months after the end of Follow-up period). 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 14 Jul 2020.