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

NCT04904224 | Unknown FDA Device

• 1 other identifier: KKF-06-2019
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 6

Brief Summary

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.

Conditions

Inflammatory Bowel Diseases; Morbus Crohn

Keywords

Abdominal Pain; Diarrhea; Video Capsule Endoscopy; Panintestinal Video Capsule Endoscopy; Fecal Calprotectin

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Study Arms (2)

PICE

ACTIVE COMPARATOR

Participants receive a panintestinal video capsule endoscopy (PICE)

Device: Panintestinal video capsule endoscopy

Colonoscopy

ACTIVE COMPARATOR

Participants receive an (Ileo-)Colonoscopy

Device: Colonoscopy

Interventions

Panintestinal video capsule endoscopy DEVICE

Performing a video capsule endoscopy using the Pill Cam Crohn's capsule from Medtronic

Also known as: PillCam Crohn's Capsule

PICE

Colonoscopy DEVICE

Performing a standard colonoscopy using the colonoscope available in the study center

Also known as: (Ileo-)Colonoscopy

Colonoscopy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Consent to study participation
• Fecal calprotectin \> 50 µg/g

You may not qualify if:

• 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

Sponsors & Collaborators

• Robert Bosch Medical Center: lead
• Medtronic: collaborator

Study Sites (6)

Praxis Gersemann

Ditzingen, Baden-Wurttemberg, 71254, Germany

RECRUITING

Praxis Escher

Leonberg, Baden-Wurttemberg, 71229, Germany

RECRUITING

Gastroenterologische Schwerpunktpraxis

Stuttgart, Baden-Wurttemberg, 70190, Germany

RECRUITING

Robert Bosch Medical Center

Stuttgart, Baden-Wurttemberg, 70376, Germany

RECRUITING

Gastroenterologie am Pragsattel

Stuttgart, Baden-Wurttemberg, 70469, Germany

RECRUITING

Ambulante Gastroenterologie

Stuttgart, Baden-Wurttemberg, 70565, Germany

RECRUITING

Related Publications (19)

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  PMID: 21056692 BACKGROUND

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  PMID: 21456899 BACKGROUND

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  PMID: 21108180 BACKGROUND

• Pennazio M, Spada C, Eliakim R, Keuchel M, May A, Mulder CJ, Rondonotti E, Adler SN, Albert J, Baltes P, Barbaro F, Cellier C, Charton JP, Delvaux M, Despott EJ, Domagk D, Klein A, McAlindon M, Rosa B, Rowse G, Sanders DS, Saurin JC, Sidhu R, Dumonceau JM, Hassan C, Gralnek IM. Small-bowel capsule endoscopy and device-assisted enteroscopy for diagnosis and treatment of small-bowel disorders: European Society of Gastrointestinal Endoscopy (ESGE) Clinical Guideline. Endoscopy. 2015 Apr;47(4):352-76. doi: 10.1055/s-0034-1391855. Epub 2015 Mar 31.

  PMID: 25826168 BACKGROUND

• Petruzziello C, Calabrese E, Onali S, Zuzzi S, Condino G, Ascolani M, Zorzi F, Pallone F, Biancone L. Small bowel capsule endoscopy vs conventional techniques in patients with symptoms highly compatible with Crohn's disease. J Crohns Colitis. 2011 Apr;5(2):139-47. doi: 10.1016/j.crohns.2010.12.004. Epub 2011 Jan 14.

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• Stange EF. Colitis ulcerosa - Morbus Crohn. UNI-MED SCIENCE, 5. Auflage, 2016

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MeSH Terms

Conditions

Inflammatory Bowel Diseases; Crohn Disease; Abdominal Pain; Diarrhea

Interventions

Endoscopy; Colonoscopy

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Digestive System Surgical Procedures

Study Officials

• Joerg G. Albert

  Robert Bosch Medical Center

  STUDY DIRECTOR

Central Study Contacts

Joerg G. Albert

CONTACT

004971181013406; joerg.albert@rbk.de

Bea Poppel

CONTACT

004971181015453; bea.poppel@rbk.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med.

Model Details: Randomized multicentric open-label study in cooperation with local gastroenterological specialist practices. A comparison is made of pan-intestinal capsule endoscopy versus colonoscopy.

Study Record Dates

• First Submitted: May 22, 2021
• First Posted: May 27, 2021
• Study Start: March 7, 2021
• Primary Completion: March 31, 2022
• Study Completion: March 31, 2023
• Last Updated: May 27, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (6)