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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
Sponsor:
Collaborator:
US Endoscopy
Information provided by (Responsible Party):
University of Colorado, Denver

Brief Summary:
Pancreatic cystic lesions (PCLs) are a common incidental finding in cross sectional imaging (up to 27% on CT scan and 41% on MRI) and pose a management challenge to physicians. According to society guidelines, PCLs with specific features should prompt additional workup with endoscopic ultrasound (EUS) for cyst characterization as well as cyst sampling. This can help determine if the cyst is mucinous or non-mucinous which has implications for its malignant potential. Cyst fluid has traditionally been sampled using EUS with fine needle aspiration (EUS-FNA) and sent for fluid analysis and cytology. More recently, the adjunctive use of the through-the-scope micro forceps (Moray micro forceps, US Endoscopy, Mentor, OH) biopsy (EUS-MFB) has shown promise for diagnosis of PCLs. This technology utilizes a micro forceps through a 19-gauge needle to biopsy the cyst wall for histology, in addition to collecting cyst fluid for CEA level and cytology. More recently, the adjunctive use of the Moray® through the needle microforceps biopsy (EUS-MFB) has shown promise for diagnosis of PCLs. This technology utilizes a microforceps through a 19-guage needle to biopsy the cyst wall for histology, in addition to collecting cyst fluid for CEA level and cytology. Only a few small retrospective reports have been published regarding the use of MFB. The results of this study will hopefully help increase diagnostic yield by obtaining a histopathologic diagnosis of these PCLs, and potentially affect practice patterns of gastroenterologists and the endoscopic community, specifically those physicians who perform EUS in these patients. Furthermore, the results will help determine whether there is reason to continue this line of research to obtain a definite histologic tissue diagnosis of PCLs.

Condition or disease Intervention/treatment Phase
Pancreatic Cyst Procedure: 1). EUS-FNA plus MFB Procedure: 2). EUS-FNA Alone Not Applicable

Detailed Description:
Pancreatic cystic lesions (PCLs) are a common incidental finding in cross sectional imaging (up to 27% on CT scan and 41% on MRI) and pose a management challenge to physicians. According to society guidelines, PCLs with specific features should prompt additional workup with endoscopic ultrasound (EUS) for cyst characterization as well as cyst sampling. This can help determine if the cyst is mucinous or non-mucinous which has implications for its malignant potential. Cyst fluid has traditionally been sampled using EUS with FNA (Fine-Needle Aspiration) and sent for fluid analysis (CEA and amylase) and cytology. However, despite use of a cyst fluid carcinoembryonic antigen (CEA) level cutoff of 192 ng/mL and cytology, accuracy of diagnosis for PCLs is poor. As the spectrum ranges from benign to high risk for neoplasm, precise diagnosis is critical. More recently, the adjunctive use of the Moray® through the needle microforceps biopsy (EUS-MFB) has shown promise for diagnosis of PCLs. This technology utilizes a microforceps through a 19-guage needle to biopsy the cyst wall for histology, in addition to collecting cyst fluid for CEA level and cytology. Only a few small retrospective reports have been published regarding the use of MFB. Pancreatic cysts continue to pose a management dilemma for practicing clinicians, especially with the increased use of radiologic imaging modalities identifying incidental pancreatic cystic lesions with higher frequency. This leads to patient anxiety and increased costs due to radiologic surveillance and even surgery. The results of this study will hopefully help increase diagnostic yield by obtaining a histopathologic diagnosis of these PCLs, and potentially affect practice patterns of gastroenterologists and the endoscopic community, specifically those physicians who perform EUS in these patients. Furthermore, the results will help determine whether there is reason to continue this line of research to obtain a definite histologic tissue diagnosis of PCLs.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Diagnostic
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.)


Secondary Outcome Measures :
  1. Technical ease in performing FNA and MFB [ Time Frame: Intraprocedural ]
    1. Ease of passage of FNA needle
    2. Ease of passage of Micro Forceps
    3. Ease of EUS visualization of Micro Forceps Technical ease will be scored on a predetermined 5-point Likert scale (1 = best, 5 = worst)

  2. Time taken for FNA and time for MFB [ Time Frame: Intraprocedural ]
    1. 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.
    2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients >18 years old
  • Cysts > 20 mm in size deemed appropriate for FNA by the endoscopist, based on clinical presentation, radiologic imaging features, associated solid mass or nodules, and patient anxiety about the diagnosis

Exclusion Criteria:

  • Age <18 years
  • Inability to provide informed consent
  • Thrombocytopenia (Platelets < 50,000) or coagulopathy (INR > 1.8)
  • Pregnancy
  • Post-surgical anatomy where the cyst is not accessible for FNA
  • EUS findings suggesting that cyst FNA would be unsafe (e.g. intervening blood vessels)
  • EUS appearance suggesting FNA is not indicated (e.g. cyst smaller than prior radiologic imaging, cyst not seen, EUS suggestive of serous cystadenoma)

Information from the National Library of Medicine

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


Contacts
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Contact: Mihir Wagh, MD 720-848-2777 mihir.wagh@cuanschutz.edu
Contact: Janelle M Medernach, MS, RDN 303-724-6070 janelle.medernach@cuanschutz.edu

Locations
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United States, California
University of California Irvine Not yet recruiting
Irvine, California, United States, 92697
Contact: Jason Samarasena, MD       jsamaras@hs.uci.edu   
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    mihir.wagh@cuanschutz.edu   
Contact: Janelle Medernach, MS, RDN    303-724-6070    janelle.medernach@cuanschutz.edu   
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    christopher.dimaio@mountsinai.org   
Contact: Rebekah Dixon    212-241-5985    Rebekah.dixon@mssm.edu   
Principal Investigator: Christopher DiMaio, MD         
Sponsors and Collaborators
University of Colorado, Denver
US Endoscopy
Investigators
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Principal Investigator: Mihir Wagh, MD University of Colorado, Denver
  Study Documents (Full-Text)

Documents provided by University of Colorado, Denver:
Informed Consent Form  [PDF] March 10, 2021

Publications:

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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT04404101    
Other Study ID Numbers: 18-1854
First Posted: May 27, 2020    Key Record Dates
Last Update Posted: August 23, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pancreatic Cyst
Cysts
Neoplasms
Pancreatic Diseases
Digestive System Diseases