Hybrid Endoscopic Stricturotomy Plus Balloon Dilation Versus Stricturotomy Alone for Short Crohn's Disease Strictures

NARecruitingINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

April 29, 2025

Primary Completion Date

March 15, 2027

Study Completion Date

May 15, 2027

Conditions
Crohn Disease (CD)
Interventions
PROCEDURE

Endoscopic Stricturotomy

"Endoscopic stricturotomy is performed using either a needle knife or an insulated-tip (IT) knife (Olympus, Tokyo, Japan), selected based on the location and morphology of the stricture. Electrosurgical cutting is delivered using the Endo Cut I mode on an ERBE VIO 300D or VIO 3 electrosurgical unit (Erbe Elektromedizin, Germany), with standardized settings: Effect 3, Cut Duration 1, Cut Interval 3.~Radial incisions are initially made across the stricture, followed by circumferential cutting in non-ulcerated areas to relieve luminal narrowing. The goal is to achieve adequate stricture opening while minimizing the risk of perforation."

PROCEDURE

Endoscopic Balloon Dilation

"Endoscopic balloon dilation is performed using a Controlled Radial Expansion (CRE) balloon (Boston Scientific, USA). The size of the balloon is selected based on the estimated diameter of the stricture, presence or absence of ulceration, and the anatomical location.~The balloon is gradually inflated under endoscopic visualization to a maximum diameter of 12-20 mm, tailored to the baseline luminal narrowing. The balloon is maintained at full inflation for 60 seconds to achieve controlled and uniform dilation of the stricture."

Trial Locations (1)

500082

RECRUITING

Asian Institute of Gastroenterology, Hyderabad

All Listed Sponsors
lead

Asian Institute of Gastroenterology, India

OTHER