Clinical trial NCT06725563: Endoscopically Placed Lumen-Apposing Metal Stents for the Treatment of Symptomatic Intestinal Strictures in Individuals With Inflammatory Bowel Disease
Official title: Endoscopically Placed Lumen-Apposing Metal Stents as a Safe Alternative to Surgery for the Treatment of Symptomatic Intestinal Strictures in Individuals With Inflammatory Bowel Disease
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Inflammatory Bowel Diseases
Stricture; Bowel
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
First posted: 2024-12-10
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Participants will receive lumen-apposing metal stents (LAMS) as a treatment for IBD-related strictures. The size of the stent used will depend on the length of the stricture. All LAMS placements are part of a single arm.
Primary purpose: TREATMENT

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 \&amp;lt; 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.

Eligibility criteria: Inclusion Criteria:

* ≥18 years of age
* Established Diagnosis of inflammatory bowel disease
* Symptomatic, single, fibrostenotic or anastomotic stricture \&lt;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

Primary outcomes:
measure: Clinical success
timeFrame: 12-months following stent removal
Secondary outcomes:
measure: Technical success
timeFrame: 1-3 months
measure: Patient satisfaction
timeFrame: 12 months
measure: Incidence of adverse events
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Ottawa Hospital Research Institute
name: Avijit Chatterjee, MD, MSc.
role: PRINCIPAL_INVESTIGATOR
References:
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