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NCT Number: NCT06725563

Endoscopically Placed Lumen-Apposing Metal Stents 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.

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Key information

Conditions

Inflammatory Bowel Diseases Constriction, Pathologic Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Intestinal Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Stricture; Bowel

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Procedure

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.

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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

  2. Patient satisfaction

    Time frame: 12 months

    Endoscopic stenting patient satisfaction measured using a decision regret form

  3. Incidence of adverse events

    Time frame: 12 months

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

Study contacts

Contact information is provided by the study sponsor or research team.

Avijit Chatterjee, MD, MSc.

CONTACT

[email protected]

6137378899 ext. 79917

Brittany Haas, MSc.

CONTACT

[email protected]

6137378899 ext. 73308

Sponsors and collaborators

Lead sponsor

Ottawa Hospital Research Institute

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 10, 2024
Registry last updated
Dec 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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