Endoscopic Balloon Dilation Versus Endoscopic Stricturotomy for Short Crohn's Strictures

NAActive, not recruitingINTERVENTIONAL
Enrollment

96

Participants

Timeline

Start Date

February 10, 2023

Primary Completion Date

April 13, 2025

Study Completion Date

April 9, 2026

Conditions
Crohn Disease
Interventions
DEVICE

Endoscopic balloon dilation

EBD procedures will be performed with wire guided CRE pneumatic balloon (controlled radial expansion balloon, Boston scientific, Marlborough, MA, USA 0of various sizes based on tightness of the stricture (10-12 mm, 12-15 mm, 15-18 mm, 18-20 mm) with graded dilations with inflation pressures varying from 3-8 ATM pressure. Balloon was inflated for at least 2 minutes and slowly deflated. A maximum of two sessions of dilation will be allowed with a minimum interval of 15-30 days between them.

DEVICE

Endoscopic stricturotomy with or without stricturoplasty

Endoscopic stricturotomy would be done using either a triple-lumen needle-knife (Boston Scientific, Marlborough, MA) or with a electrosurgical IT knife2 (Olympus Medical Systems, Tokyo, Japan) in the setting of endoscopic retrograde cholangiopancreatography (ERCP) Endocut on Erbe medical device (USA Incorporated Surgical Systems, Marietta, GA) with the following electrocautery settings : Endocut Q (effect 3, cut duration 1, cut interval 3). Strictures will be incised in a circumferential or radial fashion until an adequate passage of the scope. Endoclips may be applied post stricturotomy to act as keep treated stricture open and to prevent delayed bleeding (referred as stricturoplasty). Choice of endoclips and decision to perform stricturoplasty would be at the discretion of endoscopist.

Trial Locations (1)

500004

Asian lnstitute of Gastroenterology, Hyderabad

All Listed Sponsors
lead

Asian Institute of Gastroenterology, India

OTHER