Use of Pan-intestinal Capsule Endoscopy for Detection of Inflammatory Bowel Disease in the Case of Increased Fecal Calprotectin
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 150
- 试验地点
- 12
- 主要终点
- Number of Participants with Evidence of inflammatory Alterations in the Gastrointestinal Tract
研究概览
简要总结
The aim of this study is to discover inflammatory changes in the gastrointestinal tract in adult patients with suspicion of a chronic inflammatory bowel disease (IBD) by examining the entire bowel, including the small intestine, by using a video capsule. The study compares the video capsule endoscopy with colonoscopy with the question of inflammation and patient satisfaction with the respective examinations.
The study is aimed at participants who present to a gastroenterologist because of their complaints like persistent abdominal pain or diarrhea. An infectious genesis and celiac disease must be ruled out in advance.
In addition, the determination of the fecal calprotectin (fCal) is necessary for this study. Fecal calprotectin is a stool marker for the severity of an inflammation of the gastrointestinal tract, an increased fecal calprotectin can be an initial indication for the presence of a chronic inflammatory bowel disease.
As mentioned above, participants will be examined in one of two ways: either with an examination of the small and large intestines using video capsule endoscopy in one examination (i.e. ,panintestinal capsule endoscopy', PICE) or a colonoscopy is performed as the standard treatment. Which of the two methods is used will be decided by lot, electronically controlled.
Colon cleansing is necessary in preparation for both examinations. The advantage of being assigned to the video capsule group is, in addition to showing the entire intestine in one examination, that no sedation is necessary for this examination.
In addition to the examination, participants have to fill out a questionnaire with information about their state of affairs, their well-being and their experience with the examination. After a period of six month the participants will be contact by phone to inquire about their current state of health.
详细描述
People who contact a gastroenterologist because of persistent complaints like abdominal pain or diarrhea are suspicious having an inflammatory bowel disease and maybe meet the eligibility requirements for the study.
After checking the inclusion and exclusion criteria further necessary data (medical history, secondary diagnoses, previous examinations, etc.) as well as laboratory parameters (especially signs of inflammation and fecal calprotectin) are collected. After being informed about the study and potential risks, all patients giving written informed consent and who meet the eligibility requirements will be randomized in an open-label manner (participant and investigator) in a 1:1 ratio to video capsule endscopy intervention or colonoscopy. A follow-up by phone to evaluate the state of health is planned after six months.
The study center and established specialist practices are responsible for the study inclusion.
There will be no recruitment by advertising. Only participants who are introducing themselves due to complaints are offered study participation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- 否
入选标准
- •18 years or older
- •Apply one of the following
- •Chronic abdominal pain for at least 4 weeks, min. 3/10 points on a visual pain scale
- •Persistent diarrhea, Stool frequency of at least 4 per day
- •doctor visit due to the mentioned complaints
- •Exclusion of an infectious genesis or coeliac disease by serological testing or duodenal biopsy, if necessary
- •Consent to study participation
- •Fecal calprotectin > 50 µg/g
排除标准
- •Pregnancy
- •metastasized malignoma
- •terminal renal insufficiency, renal insufficiency requiring dialysis
- •swallowing disorder
- •age < 18 years
- •lack of consent
- •infectious genesis of symptomps
- •coeliac disease
- •Relative contraindication:
- •evidence of strictures, strictures or fistulas in the gastrointestinal tract in imaging or in high suggestive symptoms, e.g. Ileus
结局指标
主要结局
Number of Participants with Evidence of inflammatory Alterations in the Gastrointestinal Tract
时间窗: through study completion, an average of 1 year
Detection of inflammatory changes using vidoe capsule endoscopy or colonoscopy
次要结局
- Number of Diagnosis of a Chronic Inflammatory Bowel Disease(through study completion, an average of 1 year)
- Number of Participants with Indication for a Therapy because of the Examination findings(through study completion, an average of 1 year)
研究者
Jorg G. Albert
Prof. Dr. med.
Robert Bosch Medical Center