Inflammatory Bowel Diseases, Stricture; Bowel
Conditions
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.
Interventions
PROCEDUREEndoscopically placed lumen-apposing metal stents for the treatment of IBD-strictures
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.
Sponsors
Ottawa Hospital Research Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Contacts
Primary ContactAvijit Chatterjee, MD, MSc.
Backup ContactBrittany Haas, MSc.
Outcome results
None listed