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

NCT05521867 | Active Not Recruiting DMC

• 1 other identifier: AIG/IEC-BH&R 32 / 07.2022-05
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Crohn Disease

Keywords

Endoscopic balloon dilation; Endoscopic stricturotomy; Crohn's disease

Outcome Measures

Primary Outcomes (1)

• Comparison of the percentage of sustained clinical improvement in EBD and ES arms

  To compare sustained clinical improvement post EBD and ES (%) (time frame : 1year): percentage of patients having no obstructive symptoms due to CD related stenosis for which EBD/ES was performed for a period of 1 year

  1 year

Secondary Outcomes (5)

• Comparison of the percentage of patients requiring additional interventions in EBD and ES arms

  1 year

• Comparison of percentage of technical success in EBD and ES arms

  During procedure

• Comparison of the percentage of stricture related emergency department visits in EBD and ES arms

  1 year

• Comparison of the percentage of patients requiring stricture related hospitalizations in EBD and ES arms

  1 year

• Comparison of the percentage of procedure related complications related to EST versus EBD

  1 month

Study Arms (2)

Endoscopic balloon dilation

ACTIVE COMPARATOR

Confirmed Crohn's disease with gastro-duodenal or ileo-colonic short (\<3 cm) strictures (both de novo and anastomotic) without prior history of endoscopic stricture therapy

Device: Endoscopic balloon dilation

Endoscopic stricturotomy with or without stricturoplasty

ACTIVE COMPARATOR

Confirmed Crohn's disease with gastro-duodenal or ileo-colonic short (\<3 cm) strictures (both de novo and anastomotic) without prior history of endoscopic stricture therapy

Device: Endoscopic stricturotomy with or without stricturoplasty

Interventions

Endoscopic balloon dilation DEVICE

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 balloon dilation

Endoscopic stricturotomy with or without stricturoplasty DEVICE

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.

Endoscopic stricturotomy with or without stricturoplasty

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Gastro-duodenal and ileo-colonic strictures (both de novo and anastomotic strictures)
• Short strictures (\<3 cm)
• Fibrotic or mixed stricture (predominantly fibrotic)
• Strictures treated with either EST or EBD.

You may not qualify if:

• No established diagnosis of CD;
• No endoscopic therapy; and
• A combination therapy of EST and EBD at the onset
• Small bowel CD related stricture requiring enteroscopy guided dilation
• Predominantly ulcerated strictures (mixed or pure ulcerated strictures)
• Long strictures (\>3 cm)
• Pediatric Patients (\<18 years)
• Pregnant or lactating mother
• Not willing to participate

Sponsors & Collaborators

• Asian Institute of Gastroenterology, India: lead

Study Sites (1)

Asian lnstitute of Gastroenterology

Hyderabad, Telangana, 500004, India

Location

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Partha Pal, MD, DNB

  Asian lnstitute of Gastroenterology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2022
• First Posted: August 30, 2022
• Study Start: February 10, 2023
• Primary Completion: April 13, 2025
• Study Completion: April 9, 2026
• Last Updated: July 16, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)