Treatment of Perianal Fistulas in Crohn´s Disease Patients With Autologous Adipose Tissue Injection: A Randomized and Placebocontrolled Study
试验速览
- 阶段
- 2 期
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- Complete clinical healing 6 months after treatment
研究概览
简要总结
This randomized and placebo controlled study investigates the efficacy of injections with freshly harvested autologous adipose tissue in CD patients with complex perianal fistulas refractory to standard surgical and/or medical treatment. 140 CD patients will be included and randomized to either treatment with freshly harvested autologous adipose tissue or placebo (saline). Primary outcome measures are clinical healing 6 months after treatment evaluated by clinical examination and pelvic MRI.
详细描述
Injection with freshly harvested autologous adipose tissue has been reported to be an efficient treatment of perianal fistulas in patients with Crohn´s Disease (CD). In a prospective observational study 57 % of 21 patients with complex fistulas refractory to combined surgical and/or medical treatment achieved complete clinical healing of the treated fistulas from one to three injections.
This randomized and placebo controlled study aims to confirm the efficacy of injections with freshly harvested autologous adipose tissue in CD patients with perianal fistulas. 140 CD patients with complex perianal fistulas refractory to standard surgical and/or medical treatment will be included and randomized to either treatment with freshly harvested autologous adipose tissue or placebo (saline). Clinical evaluation of the treatment efficacy will also be performed in a blinded manner.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with Crohn´s Disease
- •Perianal fistula with out branching or cavities with one external and one internal opening, which due to the risk for development of incontinence is not suitable for lay-open procedure, meaning: 1) all anterior interspinchteric and low transpinchteric (involving<1/3 of spinchter) in women 2) high interspinchteric fistulas 3) high transspinchteric (>1/3 of sphincter), suprasphincteric and ekstrasphincteric fistulas 4) intersphincteric or low transsphincteric fistula in patients with fecal incontinence and/or fecal urge.
- •no or minimal luminal disease activity by colonoscopy < 3 months before treatment defined by Simple Endoscopic Severity for Crohn´s Disease<3
- •Prior optimal medical treatment for fistulas (immunmodulators, antibiotics and/or anti-TNF-alfa treatment) with out achieving fistula healing
- •Treatment with seton for a minimum of 6 weeks
- •Speaks and understand Danish
排除标准
- •Pregnancy
- •Changes in immunmodulator or anti-TNFalfa treatment < 12 weeks
- •Anovaginal fistulas
- •Rectal or anal stenosis
- •Active proctitis
- •Previous surgery for fistulas besides simpel drainage or seton
- •Insulin-dependent diabetes, conditions inducing defective immunity, pelvic radiation
- •pelvic MRI contraindicated
结局指标
主要结局
Complete clinical healing 6 months after treatment
时间窗: 6 months after treatment
No visible external opening or palpabel internal opening, no symptoms in the form of secretion and pelvic MR with out sign of fluid tracts.
次要结局
- Clinical healing 3 months after treatment(3 months after treatment)
- Reduction in symptoms 3 months after treatment(3 months)
- Partial healing 6 months after treatment(6 months)
- Reduction in symptoms 6 months after treatment(6 months)
- Changes in inconsistency 6 months after treatment(6 months)
研究者
Lilli Lundby
MD PhD
University of Aarhus