Diagnosis of Inflammatory Bowel Disease by Examining the Entire Bowel by Pan-intestinal Capsule Endoscopy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Use of Pan-intestinal Capsule Endoscopy for Detection of Inflammatory Bowel Disease in the Case of Increased Fecal Calprotectin

Conditions
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Inflammatory Bowel Diseases, Morbus Crohn

Intervention / Treatment
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* Device: Panintestinal video capsule endoscopy
* Device: Colonoscopy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized multicentric open-label study in cooperation with local gastroenterological specialist practices. A comparison is made of pan-intestinal capsule endoscopy versus colonoscopy.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PICE<br>Participants receive a panintestinal video capsule endoscopy (PICE) | Device: Panintestinal video capsule endoscopy<br>* Performing a video capsule endoscopy using the Pill Cam Crohn's capsule from Medtronic<br>* Other names: PillCam Crohn's Capsule;|
| Active Comparator: Colonoscopy<br>Participants receive an (Ileo-)Colonoscopy | Device: Colonoscopy<br>* Performing a standard colonoscopy using the colonoscope available in the study center<br>* Other names: (Ileo-)Colonoscopy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Evidence of inflammatory Alterations in the Gastrointestinal Tract | Detection of inflammatory changes using vidoe capsule endoscopy or colonoscopy | through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Diagnosis of a Chronic Inflammatory Bowel Disease | Diagnosis of inflammatory bowel disease depending on the examination findings of video capsule endoscopy or colonoscopy | through study completion, an average of 1 year | 
| Number of Participants with Indication for a Therapy because of the Examination findings | Indication for a surgical or drug therapy | through study completion, an average of 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Abdominal Pain, Diarrhea, Video Capsule Endoscopy, Panintestinal Video Capsule Endoscopy, Fecal Calprotectin