Diagnosis of Inflammatory Bowel Disease by Examining the Entire Bowel by Pan-intestinal Capsule Endoscopy
NCT ID: NCT04904224
Last Updated: 2021-05-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
150 participants
INTERVENTIONAL
2021-03-07
2023-03-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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PICE
Participants receive a panintestinal video capsule endoscopy (PICE)
Panintestinal video capsule endoscopy
Performing a video capsule endoscopy using the Pill Cam Crohn's capsule from Medtronic
Colonoscopy
Participants receive an (Ileo-)Colonoscopy
Colonoscopy
Performing a standard colonoscopy using the colonoscope available in the study center
Interventions
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Panintestinal video capsule endoscopy
Performing a video capsule endoscopy using the Pill Cam Crohn's capsule from Medtronic
Colonoscopy
Performing a standard colonoscopy using the colonoscope available in the study center
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Medtronic
INDUSTRY
Robert Bosch Medical Center
OTHER
Responsible Party
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Jorg G. Albert
Prof. Dr. med.
Principal Investigators
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Joerg G. Albert
Role: STUDY_DIRECTOR
Robert Bosch Medical Center
Locations
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Praxis Gersemann
Ditzingen, Baden-Wurttemberg, Germany
Praxis Escher
Leonberg, Baden-Wurttemberg, Germany
Gastroenterologische Schwerpunktpraxis
Stuttgart, Baden-Wurttemberg, Germany
Robert Bosch Medical Center
Stuttgart, Baden-Wurttemberg, Germany
Gastroenterologie am Pragsattel
Stuttgart, Baden-Wurttemberg, Germany
Ambulante Gastroenterologie
Stuttgart, Baden-Wurttemberg, Germany
Countries
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Central Contacts
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Facility Contacts
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Michael Gersemann
Role: primary
Markus Escher
Role: primary
Boris Uhel
Role: primary
Hartmut Goelkel
Role: backup
Oliver Mueller
Role: primary
Marcus Pichler
Role: backup
Karl M. Teubner
Role: primary
Dietmar Vogler
Role: backup
References
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Spada C, Hassan C, Galmiche JP, Neuhaus H, Dumonceau JM, Adler S, Epstein O, Gay G, Pennazio M, Rex DK, Benamouzig R, de Franchis R, Delvaux M, Deviere J, Eliakim R, Fraser C, Hagenmuller F, Herrerias JM, Keuchel M, Macrae F, Munoz-Navas M, Ponchon T, Quintero E, Riccioni ME, Rondonotti E, Marmo R, Sung JJ, Tajiri H, Toth E, Triantafyllou K, Van Gossum A, Costamagna G; European Society of Gastrointestinal Endoscopy. Colon capsule endoscopy: European Society of Gastrointestinal Endoscopy (ESGE) Guideline. Endoscopy. 2012 May;44(5):527-36. doi: 10.1055/s-0031-1291717. Epub 2012 Mar 2.
Spada C, Hassan C, Munoz-Navas M, Neuhaus H, Deviere J, Fockens P, Coron E, Gay G, Toth E, Riccioni ME, Carretero C, Charton JP, Van Gossum A, Wientjes CA, Sacher-Huvelin S, Delvaux M, Nemeth A, Petruzziello L, de Frias CP, Mayershofer R, Amininejad L, Dekker E, Galmiche JP, Frederic M, Johansson GW, Cesaro P, Costamagna G. Second-generation colon capsule endoscopy compared with colonoscopy. Gastrointest Endosc. 2011 Sep;74(3):581-589.e1. doi: 10.1016/j.gie.2011.03.1125. Epub 2011 May 20.
Stange EF. Colitis ulcerosa - Morbus Crohn. UNI-MED SCIENCE, 5. Auflage, 2016
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Albert JG, Martiny F, Krummenerl A, Stock K, Lesske J, Gobel CM, Lotterer E, Nietsch HH, Behrmann C, Fleig WE. Diagnosis of small bowel Crohn's disease: a prospective comparison of capsule endoscopy with magnetic resonance imaging and fluoroscopic enteroclysis. Gut. 2005 Dec;54(12):1721-7. doi: 10.1136/gut.2005.069427. Epub 2005 Jul 14.
Albert JG, Kotsch J, Kostler W, Behl S, Kaltz B, Bokemeyer B, Dollinger MM, Haerting J, Fleig WE. Course of Crohn's disease prior to establishment of the diagnosis. Z Gastroenterol. 2008 Feb;46(2):187-92. doi: 10.1055/s-2007-963524.
Carroccio A, Iacono G, Cottone M, Di Prima L, Cartabellotta F, Cavataio F, Scalici C, Montalto G, Di Fede G, Rini G, Notarbartolo A, Averna MR. Diagnostic accuracy of fecal calprotectin assay in distinguishing organic causes of chronic diarrhea from irritable bowel syndrome: a prospective study in adults and children. Clin Chem. 2003 Jun;49(6 Pt 1):861-7. doi: 10.1373/49.6.861.
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Dionisio PM, Gurudu SR, Leighton JA, Leontiadis GI, Fleischer DE, Hara AK, Heigh RI, Shiff AD, Sharma VK. Capsule endoscopy has a significantly higher diagnostic yield in patients with suspected and established small-bowel Crohn's disease: a meta-analysis. Am J Gastroenterol. 2010 Jun;105(6):1240-8; quiz 1249. doi: 10.1038/ajg.2009.713. Epub 2009 Dec 22.
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Hale M, McAlindon ME. Capsule endoscopy as a panenteric diagnostic tool. Br J Surg. 2014 Feb;101(3):148-9. doi: 10.1002/bjs.9321. Epub 2013 Nov 19. No abstract available.
Hale MF, Drew K, McAlindon ME, Sidhu R. The diagnostic accuracy of faecal calprotectin and small bowel capsule endoscopy and their correlation in suspected isolated small bowel Crohn's disease. Eur J Gastroenterol Hepatol. 2016 Oct;28(10):1145-50. doi: 10.1097/MEG.0000000000000696.
Hale MF, Sidhu R, McAlindon ME. Capsule endoscopy: current practice and future directions. World J Gastroenterol. 2014 Jun 28;20(24):7752-9. doi: 10.3748/wjg.v20.i24.7752.
Jensen MD, Nathan T, Rafaelsen SR, Kjeldsen J. Diagnostic accuracy of capsule endoscopy for small bowel Crohn's disease is superior to that of MR enterography or CT enterography. Clin Gastroenterol Hepatol. 2011 Feb;9(2):124-9. doi: 10.1016/j.cgh.2010.10.019. Epub 2010 Nov 5.
Jensen MD, Kjeldsen J, Nathan T. Fecal calprotectin is equally sensitive in Crohn's disease affecting the small bowel and colon. Scand J Gastroenterol. 2011 Jun;46(6):694-700. doi: 10.3109/00365521.2011.560680. Epub 2011 Apr 1.
May A, Albert J, Keuchel M, Moog G, Hartmann D. [Capsule endoscopy for the diagnosis of small bowel diseases. An updated statement by the endoscopy section of DGVS]. Z Gastroenterol. 2010 Dec;48(12):1384-404. doi: 10.1055/s-0029-1245788. Epub 2010 Nov 24. No abstract available. German.
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.
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.
Smalley W, Falck-Ytter C, Carrasco-Labra A, Wani S, Lytvyn L, Falck-Ytter Y. AGA Clinical Practice Guidelines on the Laboratory Evaluation of Functional Diarrhea and Diarrhea-Predominant Irritable Bowel Syndrome in Adults (IBS-D). Gastroenterology. 2019 Sep;157(3):851-854. doi: 10.1053/j.gastro.2019.07.004. Epub 2019 Jul 11. No abstract available.
Other Identifiers
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KKF-06-2019
Identifier Type: -
Identifier Source: org_study_id
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