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 volunteersQualifiers
≥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
Single group
Treatments tested in this trial
Endoscopically placed lumen-apposing metal stents for the treatment of IBD-strictures
Procedure/SurgeryWe 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
Trial outcomes
Primary outcomes
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)
Secondary outcomes
Technical success
defined as successful deployment of the stent without stent-related complications, including stent migration or perforation by the time of stent removal
Patient satisfaction
Endoscopic stenting patient satisfaction measured using a decision regret form
Incidence of adverse events
Incidence of post procedure adverse events (stent migration, abdominal pain, perforation, infection, bleeding)
Locations
Sponsors and contacts
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