Evaluation of Pancreatic Cystic Lesions Via EUS-guided Fine Needle Aspiration With and Without Micro Forceps Biopsies

NARecruitingINTERVENTIONAL
Enrollment

300

Participants

Timeline

Start Date

May 11, 2021

Primary Completion Date

April 30, 2025

Study Completion Date

April 30, 2025

Conditions
Pancreatic Cyst
Interventions
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.

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.

Trial Locations (3)

77030

ENROLLING_BY_INVITATION

Baylor College of Medicine, Houston

80045

RECRUITING

University of Colorado - Anschutz Medical Campus, Aurora

92697

RECRUITING

University of California Irvine, Irvine

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

US Endoscopy

INDUSTRY

lead

University of Colorado, Denver

OTHER

NCT04404101 - Evaluation of Pancreatic Cystic Lesions Via EUS-guided Fine Needle Aspiration With and Without Micro Forceps Biopsies | Biotech Hunter | Biotech Hunter