Endoscopically Placed Lumen-Apposing Metal Stents for the Treatment of Symptomatic Intestinal Strictures in Individuals With Inflammatory Bowel Disease

Not Applicable

Not yet recruiting

• Conditions: Inflammatory Bowel Diseases; Stricture; Bowel

• Registration Number: NCT06725563
• Lead Sponsor: Ottawa Hospital Research Institute

Brief Summary

This is a single-center prospective pilot study in patients with symptomatic partially obstructing intestinal strictures without severe active inflammation or penetrating complications, evaluating the use of LAMS with respect to symptom and quality of life improvement and the development of stent-related complications.

Detailed Description

This will be a prospective case series study in \~20 IBD patients with symptomatic partially-obstructing intestinal strictures \< 6 cm in length without severe active inflammation (large or deep ulcers at distal entrance or moderate-severe friability or severe inflammatory changes in the stricture on radiographic imaging, at the discretion of the referring IBD physician or treating therapeutic endoscopist) or penetrating complications (pre-stenotic fistula or intra-abdominal phlegmon or abscess), evaluating the use of LAMS with respect to symptom and quality of life improvement and the development of stent-related complications.

The objective of this project is to evaluate the safety and efficacy of LAMS for the treatment of short segment, symptomatic, IBD-related strictures.

The hope is that positive results from this pilot study will provide sufficient rationale to trigger a larger scale multicenter study to fully assess the efficacy of endoscopic stenting for IBD-related strictures.

Study Timeline

• Study First Submitted: 2024-05-28
• Status Verified: 2024-12
• Study First Submitted QC: 2024-12-04
• Last Update Submitted: 2024-12-04
• Study First Posted: 2024-12-10
• Last Update Posted: 2024-12-10
• Study Start: 2025-01-01
• Primary Completion: 2026-09-30
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• ≥18 years of age
• Established Diagnosis of inflammatory bowel disease
• Symptomatic, single, fibrostenotic or anastomotic stricture <6 cm in length without severe active inflammation, pre-stenotic intestinal fistula or penetrating complication, and within reach of the adult colonoscope (colon or terminal ileum)
• Ability to accurately gauge stricture length with imaging and safely deploy the stent using conventional fluoroscopic techniques
• Able to provide informed consent

Exclusion Criteria

• More than one intestinal stricture
• Stricture out of reach of standard adult colonoscope
• High-grade stricture (complete or near complete bowel obstruction
• Severe active inflammation in the stricture or associated penetrating complication, including fistula, inflammatory phlegmon or abscess
• Contraindications for endoscopic therapy, including:
• Complete Bowel obstruction
• Severe cardiorespiratory comorbidity
• Unable to tolerate sedation or anesthesia
• Non-reversible coagulopathy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Clinical success	12-months following stent removal	defined as persistent improvement of obstructive symptoms and establishment of adequate oral caloric intake at 12 months following stent removal, measured using quality of life pre- and post-endoscopic stenting measured using short inflammatory bowel disease questionnaire (SIBDQ), pre- and post-stenting nutritional/health outcomes measured using Saskatchewan IBD-Nutrition Risk (SaskIBD-NR Tool)

Secondary Outcome Measures

Name	Time	Method
Technical success	1-3 months	defined as successful deployment of the stent without stent-related complications, including stent migration or perforation by the time of stent removal
Patient satisfaction	12 months	Endoscopic stenting patient satisfaction measured using a decision regret form
Incidence of adverse events	12 months	Incidence of post procedure adverse events (stent migration, abdominal pain, perforation, infection, bleeding)