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

NCT06725563 | Not Yet Recruiting DMC

• 1 other identifier: CRRF ID: 5849
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Inflammatory Bowel Diseases; Stricture; Bowel

Outcome Measures

Primary Outcomes (1)

• 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)

  12-months following stent removal

Secondary Outcomes (3)

• Technical success

  1-3 months

• Patient satisfaction

  12 months

• Incidence of adverse events

  12 months

Study Arms (1)

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

EXPERIMENTAL

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

Interventions

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.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead

Related Publications (16)

• Coward S, Benchimol EI, Kuenzig ME, Windsor JW, Bernstein CN, Bitton A, Jones JL, Lee K, Murthy SK, Targownik LE, Pena-Sanchez JN, Rohatinsky N, Ghandeharian S, Im JHB, Davis T, Weinstein J, Goddard Q, Bennett J, Caplan L, Bergevin M, Yang XY, Mason K, Sanderson R, Brass C, Kaplan GG. The 2023 Impact of Inflammatory Bowel Disease in Canada: Epidemiology of IBD. J Can Assoc Gastroenterol. 2023 Sep 5;6(Suppl 2):S9-S15. doi: 10.1093/jcag/gwad004. eCollection 2023 Sep.

  PMID: 37674492 BACKGROUND

• Mitropoulou MA, Fradelos EC, Lee KY, Malli F, Tsaras K, Christodoulou NG, Papathanasiou IV. Quality of Life in Patients With Inflammatory Bowel Disease: Importance of Psychological Symptoms. Cureus. 2022 Aug 28;14(8):e28502. doi: 10.7759/cureus.28502. eCollection 2022 Aug.

  PMID: 36185946 BACKGROUND

• Nasr S, Dahmani W, Jaziri H, Hammami A, Slama AB, Ameur WB, Elleuch N, Ksiaa M, Jmaa A. Exploring work productivity loss in patients with inflammatory bowel disease. Future Sci OA. 2023 Jun 7;9(8):FSO872. doi: 10.2144/fsoa-2022-0034. eCollection 2023 Sep.

  PMID: 37621842 BACKGROUND

• Shen B. Principles, Preparation, Indications, Precaution, and Damage Control of Endoscopic Therapy in Inflammatory Bowel Disease. Gastrointest Endosc Clin N Am. 2022 Oct;32(4):597-614. doi: 10.1016/j.giec.2022.05.005. Epub 2022 Sep 7.

  PMID: 36202505 BACKGROUND

• Kuenzig ME, Benchimol EI, Lee L, Targownik LE, Singh H, Kaplan GG, Bernstein CN, Bitton A, Nguyen GC, Lee K, Cooke-Lauder J, Murthy SK. The Impact of Inflammatory Bowel Disease in Canada 2018: Direct Costs and Health Services Utilization. J Can Assoc Gastroenterol. 2019 Feb;2(Suppl 1):S17-S33. doi: 10.1093/jcag/gwy055. Epub 2018 Nov 2.

  PMID: 31294382 BACKGROUND

• Lin V, Gogenur S, Pachler F, Fransgaard T, Gogenur I. Risk Prediction for Complications in Inflammatory Bowel Disease Surgery: External Validation of the American College of Surgeons' National Surgical Quality Improvement Program Surgical Risk Calculator. J Crohns Colitis. 2023 Jan 27;17(1):73-82. doi: 10.1093/ecco-jcc/jjac114.

  PMID: 35973971 BACKGROUND

• Wiebe K, Kelley S, Kirsch RE. Revisiting the concept of urgency in surgical prioritization and addressing backlogs in elective surgery provision. CMAJ. 2022 Aug 2;194(29):E1037-E1039. doi: 10.1503/cmaj.220420. No abstract available.

  PMID: 35918085 BACKGROUND

• Springer JE, Doumouras AG, Saleh F, Lee J, Amin N, Cadeddu M, Eskicioglu C, Hong D. Drivers of Inpatient Costs After Colorectal Surgery Within a Publicly Funded Healthcare System. Dis Colon Rectum. 2019 Jun;62(6):747-754. doi: 10.1097/DCR.0000000000001309.

  PMID: 31094961 BACKGROUND

• Jeong SJ, Park J. Endoscopic Management of Benign Colonic Obstruction and Pseudo-Obstruction. Clin Endosc. 2020 Jan;53(1):18-28. doi: 10.5946/ce.2019.058. Epub 2019 Oct 24.

  PMID: 31645090 BACKGROUND

• Jena A, Chandnani S, Jain S, Sharma V, Rathi P. Efficacy of endoscopic over-the-scope clip fixation for preventing migration of self-expandable metal stents: a systematic review and meta-analysis. Surg Endosc. 2023 May;37(5):3410-3418. doi: 10.1007/s00464-023-09893-z. Epub 2023 Jan 30.

  PMID: 36717426 BACKGROUND

• Sharma P, McCarty TR, Chhoda A, Costantino A, Loeser C, Muniraj T, Ryou M, Thompson CC. Alternative uses of lumen apposing metal stents. World J Gastroenterol. 2020 Jun 7;26(21):2715-2728. doi: 10.3748/wjg.v26.i21.2715.

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  PMID: 34092973 BACKGROUND

• Chandan S, Dhindsa BS, Khan SR, Deliwala S, Kassab LL, Mohan BP, Chandan OC, Loras C, Shen B, Kochhar GS. Endoscopic Stenting in Crohn's Disease-related Strictures: A Systematic Review and Meta-analysis of Outcomes. Inflamm Bowel Dis. 2023 Jul 5;29(7):1145-1152. doi: 10.1093/ibd/izac153.

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  PMID: 33722805 BACKGROUND

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Constriction, Pathologic

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Avijit Chatterjee, MD, MSc.

  Ottawa Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Avijit Chatterjee, MD, MSc.

CONTACT

6137378899; achatterjee@toh.ca

Brittany Haas, MSc.

CONTACT

6137378899; bhaas@ohri.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 28, 2024
• First Posted: December 10, 2024
• Study Start: January 1, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 10, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share