Endoscopically Placed Lumen-Apposing Metal Stents for the Treatment of Symptomatic Intestinal Strictures in Individuals With Inflammatory Bowel Disease
NCT ID: NCT06725563
Last Updated: 2024-12-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
20 participants
INTERVENTIONAL
2025-01-01
2026-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Ottawa Hospital Research Institute
OTHER
Responsible Party
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Principal Investigators
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Avijit Chatterjee, MD, MSc.
Role: PRINCIPAL_INVESTIGATOR
Ottawa Hospital Research Institute
Central Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Nunez F P, Krugliak Cleveland N, Quera R, Rubin DT. Evolving role of endoscopy in inflammatory bowel disease: Going beyond diagnosis. World J Gastroenterol. 2021 May 28;27(20):2521-2530. doi: 10.3748/wjg.v27.i20.2521.
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.
Medas R, Ferreira-Silva J, Girotra M, Barakat M, Tabibian JH, Rodrigues-Pinto E. Best Practices in Esophageal, Gastroduodenal, and Colonic Stenting. GE Port J Gastroenterol. 2022 Nov 7;30(Suppl 1):19-34. doi: 10.1159/000527202. eCollection 2023 Sep.
Das R, Singh R, Din S, Lund J, Krishnamoorthy R, Hearing S, Norton B, Williams J, Fraser C, Goddard A, Cole A. Therapeutic resolution of focal, predominantly anastomotic Crohn's disease strictures using removable stents: outcomes from a single-center case series in the United Kingdom. Gastrointest Endosc. 2020 Aug;92(2):344-352. doi: 10.1016/j.gie.2020.01.053. Epub 2020 Feb 18.
Hedenstrom P, Stotzer PO. Endoscopic treatment of Crohn-related strictures with a self-expandable stent compared with balloon dilation: a prospective, randomised, controlled study. BMJ Open Gastroenterol. 2021 Mar;8(1):e000612. doi: 10.1136/bmjgast-2021-000612.
Other Identifiers
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CRRF ID: 5849
Identifier Type: -
Identifier Source: org_study_id