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Endoscopic Balloon Dilation Versus Endoscopic Stricturotomy for Short Crohn's Strictures
Sponsor: Asian Institute of Gastroenterology, India
Summary
Crohn's disease (CD) related strictures can be treated endoscopically by endoscopic balloon dilation (EBD) or endoscopic stricturotomy (EST). EBD is is the established endoscopic treatment for short strictures in Crohn's disease. However, roughly half had recurrent symptoms and two third require surgery after EBD. ES have been used initially for endoscopic treatment of patients for whom EBD was unsuccessful. Subsequently it was shown that ES is a better modality for treating CD related strictures (specially short and anastomotic strictures) than EBD lowering the risk of future surgery and procedure related perforation albeit with an increased risk of bleeding. ES was shown to be non-inferior to re-do surgery in chronic pouch anastomotic sinus in ulcerative colitis (UC) and ileocolic anastomotic strictures in CD thus reducing surgical morbidity. However, these two modalities have not been compared in a randomized controlled manner. We aimed to compare the two endoscopic treatments with regard to clinical success, need for surgery or additional endoscopic procedure and safety in patients with CD who have short (\<3 cm), predominantly fibrotic stenosis excluding those in the small bowel not accessible by endoscope/colonoscope.
Official title: Randomized Controlled Trial Comparing Endoscopic Balloon Dilation Versus Endoscopic Stricturotomy for Short Strictures (< 3 cm) Related to Crohn's Disease (the BEST-CD Trial)
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
96
Start Date
2023-02-10
Completion Date
2026-04-09
Last Updated
2025-07-16
Healthy Volunteers
No
Conditions
Interventions
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.
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.
Locations (1)
Asian lnstitute of Gastroenterology
Hyderabad, Telangana, India