Recruiting

EUS-guided FNA & Micro Forceps Biopsies

Sponsor:

University of Colorado, Denver

Code:

NCT04404101

Conditions

Pancreatic Cyst

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

1). EUS-FNA plus MFB

2). EUS-FNA Alone

Study Details

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 micro forceps 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. 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.

Conditions

Pancreatic Cyst

Study ID

NCT04404101

Start date

May 11, 2021

Status verified date

May, 2024

Completion date

Apr, 2025

Anticipated

Primary completion date

Apr, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

300 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

active comparator: 1). EUS-FNA plus MFB

A 19-G needle plus micro-forceps will be used for FNA plus MFB.

active comparator: 2). EUS-FNA Alone

A 19-G needle will be used for FNA alone.

Interventions

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.

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 measure

  • Technical Success of EUS-FNA plus MFB, with EUS-FNA alone for evaluation of PCLs. [ Time Frame: Intraprocedural ]
  • Clinical Success of EUS-FNA plus MFB, with EUS-FNA alone for evaluation of PCLs. [ Time Frame: 0-4 weeks ]
  • 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 ]

Central Contacts and Locations

Central contacts

Anna Duloy, MD

+13037248892anna.duloy@cuanschutz.edu

Sandra Boimbo

sandra.boimbo@cuanschutz.edu

Locations

University of California Irvine

Recruiting

Irvine, California, United States, 92697

Contacts

Jason Samarasena, MD

jsamaras@hs.uci.edu

Hailey Maxwell

maxwellh@hs.uci.edu

Principal Investigator:

Jason Samarasena, MD

University of Colorado - Anschutz Medical Campus

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Sandra Boimbo

sandra.boimbo@cuanschutz.edu

Peter Tiley

peter.tiley@cuanschutz.edu

Principal Investigator:

Anna Duloy, MD

More Information

Sponsor

University of Colorado, Denver

Last update posted

May 21, 2024

Last verified

May, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Colorado, Denver on 2024-05-21.