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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
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.
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
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
Patient satisfaction
Endoscopic stenting patient satisfaction measured using a decision regret form
Time frame: 12 months
Incidence of adverse events
Incidence of post procedure adverse events (stent migration, abdominal pain, perforation, infection, bleeding)
Time frame: 12 months
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