跳至主要内容
临床试验/NCT02193802
NCT02193802Unknown不适用

Role of Capsule Endoscopy in the Evaluation of Mucosal Changes During Treatment of Patients With Active Crohn's Disease

Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives22 个研究点 分布在 2 个国家目标入组 42 人开始时间: 2014年5月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
42
试验地点
22
主要终点
Evaluate the agreement between capsule and ileocolonoscopy in the change of physician global assessment (PGA) as visualized in the TI in patients under treatment.

研究概览

简要总结

The utility of capsule endoscopy in diagnosing small bowel (SB) Crohn's disease has been demonstrated in a number of studies.

Mucosal healing is a good predictor of long term remission. Unfortunately, the assessment of small bowel mucosal healing by conventional colonoscopy is an invasive technique which is not complete since it does not allow exploration of the small bowel beyond the terminal ileum (TI). Thus, direct evidence of the healing of the majority of the small bowel is lacking.

详细描述

Crohn's disease is a chronic, inflammatory disorder affecting any part of the gastrointestinal tract but the terminal ileum is the most frequent location involved alone or in combination with other locations. While about one half of patients have involvement of the ileum and large bowel, another third have disease limited to the small bowel.

The disease affects populations around the globe and occurs at any age but tends to have a peak incidence between the ages of 15 and 35. Typical presenting symptoms include abdominal pain and diarrhea. The clinical presentation of Crohn's disease fluctuates throughout the course of the disease. Symptoms and signs usually correlate with mucosal inflammation. The pattern of Crohn's disease viewed on endoscopy has been characterized and is associated with a number of mucosal characteristics such as erythema, swelling, nodularity, strictures, aphthoid ulceration and ulcers of variable size and depth.

The utility of capsule endoscopy in diagnosing small bowel (SB) Crohn's disease has been demonstrated in a number of studies. Diagnostic yields of 70% have been reported in suspected SB Crohn's disease. In patients with a known Crohn's disease, the superiority of the capsule to detect mucosal lesions of the SB in comparison to any other radiologic technique has also been clearly demonstrated.

A number of studies indicate that mucosal healing is a good predictor of long term remission. In particular, intense therapeutic regimens including purine analogues and biologic therapies like infliximab have been associated with endoscopic mucosal healing. The recently published SONIC trial evaluated the efficacy of infliximab monotherapy, azathioprine monotherapy and the two drugs combined in moderate to severe Crohn's disease patients. Patients who were treated with infliximab monotherapy and with the combination therapy had significantly longer corticosteroid-free clinical remission than those receiving azathioprine alone. Furthermore, mucosal healing, defined as the absence of mucosal ulcerations at week 26, was greater for the combination therapy than each of the monotherapies alone. Based on the results of these studies, obtaining a mucosal healing becomes in clinical practice a new therapeutic objective especially in patients treated by immunosuppressors or anti-TNF-alpha antibodies. In most of the studies, a complete mucosal healing was assessed by the complete disappearance of ulceration. An endoscopic response could be evaluated by the variation of several endoscopic scores of severity, that are either dedicated to the terminal ileon (TI) more the colon i.e. the Crohn's disease endoscopic severity index (CDEIS) or to the SB i.e. the Lewis score. Concerning the evaluation of the mucosal lesions of the SB by the capsule, a new index of severity is being developed in a study conducted by the different centers of the GETAID i.e. the CE-CDEIS. This score will be available in the first semester of 2013 and would be usable for the present study.

Unfortunately, the assessment of mucosal healing by conventional ileocolonoscopy is not complete since it does not allow exploration of the small bowel beyond TI. Thus, while mucosal changes and symptomatic improvement in subjects with SB Crohn's disease (with or without colonic involvement) can be inferred from studies like ACCENT I, direct evidence of the healing of the majority of the small bowel is lacking. In addition, correlation between evidence of mucosal healing and symptoms, as measured by the Crohn's Disease Activity Index (CDAI), has not been found reliable. This may reflect the limitation of viewing the full extent of small bowel ulcerations on the limited examination which is possible with ileocolonoscopy. This may potentially be overcome with the use of capsule endoscopy of the small bowel.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
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

入选标准

  • Subject aged more than 18 years
  • Subject with at least ileal lesions of Crohn's disease
  • Subject with moderate to severe Crohn's disease at baseline, as defined by CDAI > 150,
  • Subject accepting to undergo two capsules endoscopy and Ileocolonoscopy procedures
  • Proven patency by Agile capsule or another approach deemed clinically acceptable by the investigator, e.g. CT enterography or MRI enterography, performed within the 6 months prior to enrollment

排除标准

  • Known gastrointestinal obstruction or strictures based on the clinical picture or pre procedure testing and profile
  • Cardiac pacemakers or other implanted electromedical devices
  • Swallowing disorders.
  • Subject with known slow gastric emptying
  • Contraindications to ileocolonoscopy or general anasthesia
  • Subject with any condition, which precludes compliance with study and/or device instructions
  • Women who are either pregnant or nursing at the time of screening, who intend to be during the study period, or are of child-bearing potential and do not practice medically acceptable methods of contraception.
  • Subject suffers from life threatening conditions
  • Subject currently participating in another clinical study
  • Subject has taken NSAID medications less than one month before enrollment

结局指标

主要结局

Evaluate the agreement between capsule and ileocolonoscopy in the change of physician global assessment (PGA) as visualized in the TI in patients under treatment.

时间窗: week 0 and after 6 at 12 months

PGA will be evaluated based on capsule or Ileocolonoscopy procedures at week 0 and after 6 at 12 months in two ways as follows: Quantitative PGA assessment: the severity of the disease will be graded on an analogue visual scaled from 0 (no lesions identified) to 10 (lesions of maximum severity identified). Qualitative PGA assessment: the severity of the disease at weeks 0 and 40 will be classified into one of the following categories: * No active disease * Mild disease * Moderate disease * Severe disease Physician global assessment of the disease severity variation will be classified into: * Definite Improvement * Slightly improvement * No change * Slightly worsening * Definite Worsening Disease severity variation will be also quantified by the change in quantitative PGA. The disease global severity will be later estimated by the two independent local investigators based on the previously capsule small bowel PGA and on the colonoscopy previously colon PGA.

次要结局

  • Lewis score(week 0 and after 6 at 12 months)
  • Segmental ileal and global CDEIS score(week 0 and after 6 at 12 months)

研究者

发起方
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
申办方类型
Other
责任方
Sponsor

研究点 (22)

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