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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorOttawa Hospital Research Institute

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

≥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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

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

    Procedure/Surgery

    We will apply standard procedures for endoluminal stenting. A therapeutic colonoscope will be advanced through the bowel up until the stricture. A guidewire will be passed through the lumen at the stricture site. LAMS will be used for strictures \<6cm, with stents ranging in size from 10-16mm in diameter and up to 60mm in length. The stent will be deployed across the stricture with the assistance of endoscopic and fluoroscopic imaging. Individuals will undergo a repeat colonoscopy in 1-3 months to remove the stent.

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Endoscopically placed lumen-apposing metal stents for the treatment of IBD-stricturesExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Clinical success

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)

Time frame
12-months following stent removal

Secondary outcomes

1

Technical success

defined as successful deployment of the stent without stent-related complications, including stent migration or perforation by the time of stent removal

Time frame
1-3 months
2

Patient satisfaction

Endoscopic stenting patient satisfaction measured using a decision regret form

Time frame
12 months
3

Incidence of adverse events

Incidence of post procedure adverse events (stent migration, abdominal pain, perforation, infection, bleeding)

Time frame
12 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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