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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура 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 mont

Первичные конечные точки

• Clinical success [Срок оценки: 12-months following stent removal]

Вторичные конечные точки (3)

• Technical success [Срок оценки: 1-3 months]
• Patient satisfaction [Срок оценки: 12 months]
• Incidence of adverse events [Срок оценки: 12 months]

Критерии участия

Критерии включения

• ≥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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• 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 PMID 37674492
• 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
• 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
• 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
• 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
• 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
• 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
• 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

Идентификаторы

NCT: NCT06725563 · CRRF ID: 5849

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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