Evaluation of Pancreatic Cystic Lesions Via EUS-guided Fine Needle Aspiration With and Without Micro Forceps Biopsies
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|ClinicalTrials.gov Identifier: NCT04404101|
Recruitment Status : Recruiting
First Posted : May 27, 2020
Last Update Posted : August 23, 2021
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Cyst||Procedure: 1). EUS-FNA plus MFB Procedure: 2). EUS-FNA Alone||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Evaluation of Pancreatic Cystic Lesions Via EUS-Guided Fine Needle Aspiration With and Without Micro Forceps Biopsies: A Multi-Center Prospective Randomized Study|
|Actual Study Start Date :||May 11, 2021|
|Estimated Primary Completion Date :||April 2024|
|Estimated Study Completion Date :||April 2025|
Active Comparator: 1). EUS-FNA plus MFB
A 19-G needle plus micro-forceps will be used for FNA plus MFB.
Procedure: 1). EUS-FNA plus MFB
The cyst will be punctured using a 19-G EUS-FNA needle with a stylet. A transgastric approach will be used for PCLs located in body/tail region, and a transduodenal approach for PCLs in the head/neck region, or as determined by the endoscopist. The stylet will be removed and the wall of the cyst biopsied using the micro forceps passed through the 19 G needle under direct EUS visualization. A minimum of 4 cyst wall biopsies will be obtained to procure at least 4 visible tissue fragments. Cyst fluid will be aspirated and sent for CEA and cytology.
Active Comparator: 2). EUS-FNA Alone
A 19-G needle will be used for FNA alone.
Procedure: 2). EUS-FNA Alone
The cyst will be punctured using an EUS-FNA needle with a stylet. A transgastric approach will be used for PCLs located in body/tail region, and a transduodenal approach for PCLs in the head/neck region, or as determined by the endoscopist. The stylet will be removed, and cyst fluid will be aspirated and sent for CEA, and cytology.
- Technical Success of EUS-FNA plus MFB, with EUS-FNA alone for evaluation of PCLs. [ Time Frame: Intraprocedural ](1) Technical success will be defined as the ability to puncture the cyst with the FNA needle under EUS guidance, advance the micro forceps into the cyst to perform cyst biopsies and obtain a visible tissue fragment.
- Clinical Success of EUS-FNA plus MFB, with EUS-FNA alone for evaluation of PCLs. [ Time Frame: 0-4 weeks ](2) Clinical success will be defined as the ability to obtain a pathologic tissue diagnosis (diagnostic yield) of the PCL with MFB. Based on prior experience, expected diagnoses include pseudocyst, serous cystadenoma, mucinous cyst (mucinous cystic neoplasm, intra-ductal papillary mucinous neoplasm), adenocarcinoma, and neuroendocrine tumor, to name a few.
- Safety of EUS-FNA plus MFB with that of EUS-FNA by recording adverse events per published ASGE (American Society for Gastrointestinal Endoscopy) criteria. [ Time Frame: 0-4 Weeks ]Intraprocedural and post-procedural adverse events (e.g. bleeding, infection, perforation, pancreatitis, etc.)
- Technical ease in performing FNA and MFB [ Time Frame: Intraprocedural ]
- Ease of passage of FNA needle
- Ease of passage of Micro Forceps
- Ease of EUS visualization of Micro Forceps Technical ease will be scored on a predetermined 5-point Likert scale (1 = best, 5 = worst)
- Time taken for FNA and time for MFB [ Time Frame: Intraprocedural ]
- Time for FNA will defined as time when FNA needle is introduced into the channel of the echoendoscope to the time cyst fluid is collected in the specimen tube/jar.
- Time for MFB will be defined as the time when micro forceps is introduced into the FNA needle for the first pass to the time when last tissue fragment is collected into the specimen jar after the last pass.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04404101
|Contact: Mihir Wagh, MDfirstname.lastname@example.org|
|Contact: Janelle M Medernach, MS, RDNemail@example.com|
|United States, California|
|University of California Irvine||Not yet recruiting|
|Irvine, California, United States, 92697|
|Contact: Jason Samarasena, MD firstname.lastname@example.org|
|Principal Investigator: Jason Samarasena, MD|
|United States, Colorado|
|University of Colorado - Anschutz Medical Campus||Recruiting|
|Aurora, Colorado, United States, 80045|
|Contact: Mihir Wagh, MD 720-848-2777 email@example.com|
|Contact: Janelle Medernach, MS, RDN 303-724-6070 firstname.lastname@example.org|
|Principal Investigator: Mihir Wagh, MD|
|United States, New York|
|Mt. Sinai||Not yet recruiting|
|New York, New York, United States, 10029|
|Contact: Christopher DiMaio, MD 212-241-5985 email@example.com|
|Contact: Rebekah Dixon 212-241-5985 Rebekah.firstname.lastname@example.org|
|Principal Investigator: Christopher DiMaio, MD|
|Principal Investigator:||Mihir Wagh, MD||University of Colorado, Denver|