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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 主要终点
- Clinical success
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Endoscopically placed lumen-apposing metal stents for the treatment of IBD-strictures (Procedure)
结局指标
主要结局
Clinical success
时间窗: 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)
次要结局
- Technical success(1-3 months)
- Patient satisfaction(12 months)
- Incidence of adverse events(12 months)