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

Ottawa Hospital Research Institute

Status: Not yet enrolling

Conditions: Stricture; Bowel; Inflammatory Bowel Diseases

Treatments: Procedure: Endoscopically placed lumen-apposing metal stents for the treatment of IBD-strictures

Study type: Interventional

Funder types: Other

Identifiers

NCT06725563

CRRF ID: 5849

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Endoscopically placed lumen-apposing metal stents for the treatment of IBD-strictures

Experimental group

Description:

Individuals will receive endoscopic lumen-apposing metal stents. The specific size of the stent used will depend on the length of the stricture. All LAMS placements are part of one arm.

Treatment:

Procedure: Endoscopically placed lumen-apposing metal stents for the treatment of IBD-strictures