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

December 4, 2024 updated by: Ottawa Hospital Research Institute

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Avijit Chatterjee, MD, MSc.
  • Phone Number: 79917 6137378899
  • Email: achatterjee@toh.ca

Study Contact Backup

  • Name: Brittany Haas, MSc.
  • Phone Number: 73308 6137378899
  • Email: bhaas@ohri.ca

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Endoscopically placed lumen-apposing metal stents for the treatment of IBD-strictures
Individuals will receive endoscopic lumen-apposing metal stents. The specific size of the stent used will depend on the length of the stricture. All LAMS placements are part of one arm.
Procedure: Endoscopically 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical success
Time Frame: 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)
12-months following stent removal

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Technical success
Time Frame: 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
1-3 months
Patient satisfaction
Time Frame: 12 months
Endoscopic stenting patient satisfaction measured using a decision regret form
12 months
Incidence of adverse events
Time Frame: 12 months
Incidence of post procedure adverse events (stent migration, abdominal pain, perforation, infection, bleeding)
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ottawa Hospital Research Institute

Investigators

  • Principal Investigator: Avijit Chatterjee, MD, MSc., Ottawa Hospital Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2025

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

May 28, 2024

First Submitted That Met QC Criteria

December 4, 2024

First Posted (Estimated)

December 10, 2024

Study Record Updates

Last Update Posted (Estimated)

December 10, 2024

Last Update Submitted That Met QC Criteria

December 4, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRRF ID: 5849

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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