Capsule Endoscopy in Inflammatory Bowel Disease (IBD) in Children
NCT ID: NCT02182947
Last Updated: 2021-03-11
Study Results
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View full resultsBasic Information
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COMPLETED
NA
45 participants
INTERVENTIONAL
2012-08-31
2018-12-30
Brief Summary
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Detailed Description
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Magnetic resonance enterography (MRE) and small bowel contrast ultrasound (SICUS) have diagnostic effectiveness comparable to other radiological modalities for evaluation of CD patients. However, both studies have their own limitations, MRE is limited by expense, the availability of the requisite equipment and software, variable expertise in interpretation of the findings, and (potentially) the need for sedation in pediatric population. SICUS is similarly affected by being operator dependent with the requisite need of accumulated expertise and heightened need for cooperation during the study that can limit its use in pediatric populations.
Several diagnostic modalities have been evaluated in comparison to WCE in several pediatric and adult IBD studies. The studies conducted in children with IBD were mostly retrospective and aimed at evaluating the role of MRE and WCE for detection of SB disease. They concluded that MRE and WCE were comparable with similar sensitivities. Only three prospective studies (all European) in pediatric IBD have compared WCE and MRE modalities in identifying SB disease involvement. Two were studies in established CD and one in suspected CD and again, they suggested that the tests appear complementary for detection of active CD. The current study is the a another prospective study in children with established IBD in the United States assessing the roles of MRE and WCE in identifying SB disease involvement in IBD. This study provides evidence for capsule endoscopy in the evaluation of established disease exacerbation in patients with IBD in relation to MRE.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Endoscopy Imaging
Wireless-video capsule endoscopy (WCE) compared to the findings of MRE magnetic resonance enterography in same group of patients.
Capsule endoscopy
Pediatric patients with indeterminate colitis (IC) or Crohn's disease (CD) who are scheduled to undergo routine small bowel screening or surveillance using MRE. Subjects will swallow a patency capsule (PC) to study bowel patency.Those patients, who pass an intact PC, usually within 40 hours, will ingest the wireless capsule endoscopy (WCE). The WCE will be performed within 1 week of completion of MRE.
Interventions
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Capsule endoscopy
Pediatric patients with indeterminate colitis (IC) or Crohn's disease (CD) who are scheduled to undergo routine small bowel screening or surveillance using MRE. Subjects will swallow a patency capsule (PC) to study bowel patency.Those patients, who pass an intact PC, usually within 40 hours, will ingest the wireless capsule endoscopy (WCE). The WCE will be performed within 1 week of completion of MRE.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* IBD/CD and IBD/IC diagnosed based on standard clinical - histologic criteria
* Patient is scheduled to have MRE as standard of care for evaluation of disease severity/ complication.
* Signed permission/assent/consent
Exclusion Criteria
* Recent intestinal tract surgery / resection involving small bowel
* Use of NSAIDs 4 weeks prior to the Capsule endoscopy study.
* Patients are on prokinetic medication.
* Swallowing disorders, esophageal stricture or patients unable to swallow the capsule.
* Presence of gastrointestinal obstruction or ileus.
* Patient with implanted electro-medical device or pacemakers.
4 Years
17 Years
ALL
No
Sponsors
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Medtronic - MITG
INDUSTRY
Children's Mercy Hospital Kansas City
OTHER
Responsible Party
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Nadia Hijaz
MD
Principal Investigators
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Nadia M Hijaz, MD
Role: PRINCIPAL_INVESTIGATOR
Children's Mercy
Locations
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Children Mercy Hospital and Clinics
Kansas City, Kansas, United States
Countries
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References
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Cuffari C, Dubinsky M, Darbari A, Sena L, Baldassano R. Crohn's jejunoileitis: the pediatrician's perspective on diagnosis and management. Inflamm Bowel Dis. 2005 Jul;11(7):696-704. doi: 10.1097/01.mib.0000166933.74477.69.
North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition; Colitis Foundation of America; Bousvaros A, Antonioli DA, Colletti RB, Dubinsky MC, Glickman JN, Gold BD, Griffiths AM, Jevon GP, Higuchi LM, Hyams JS, Kirschner BS, Kugathasan S, Baldassano RN, Russo PA. Differentiating ulcerative colitis from Crohn disease in children and young adults: report of a working group of the North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition and the Crohn's and Colitis Foundation of America. J Pediatr Gastroenterol Nutr. 2007 May;44(5):653-74. doi: 10.1097/MPG.0b013e31805563f3.
Levi Z, Fraser E, Krongrad R, Hazazi R, benjaminov O, meyerovitch J, Tal OB, Choen A, Niv Y, Fraser G. Factors associated with radiation exposure in patients with inflammatory bowel disease. Aliment Pharmacol Ther. 2009 Dec 1;30(11-12):1128-36. doi: 10.1111/j.1365-2036.2009.04140.x.
Deviere J, Hochberger J, Neuhaus H, Ponchon T, Eugenidis N, Neumann C, Ladas S. Recommendations of the ESGE workshop on Ethical, Clinical, and Economic Dilemmas Arising from the Implementation of New Techniques. First European Symposium on Ethics in Gastroenterology and Digestive Endoscopy, Kos, Greece, June 2003. Endoscopy. 2003 Sep;35(9):768-71. doi: 10.1055/s-2003-41587. No abstract available.
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.
Moy L, Levine J. Capsule endoscopy in the evaluation of patients with unexplained growth failure. J Pediatr Gastroenterol Nutr. 2009 May;48(5):647-50. doi: 10.1097/MPG.0b013e31818b0ac7.
Casciani E, Masselli G, Di Nardo G, Polettini E, Bertini L, Oliva S, Floriani I, Cucchiara S, Gualdi G. MR enterography versus capsule endoscopy in paediatric patients with suspected Crohn's disease. Eur Radiol. 2011 Apr;21(4):823-31. doi: 10.1007/s00330-010-1976-3. Epub 2010 Oct 5.
Di Nardo G, Oliva S, Ferrari F, Riccioni ME, Staiano A, Lombardi G, Costamagna G, Cucchiara S, Stronati L. Usefulness of wireless capsule endoscopy in paediatric inflammatory bowel disease. Dig Liver Dis. 2011 Mar;43(3):220-4. doi: 10.1016/j.dld.2010.10.004. Epub 2010 Nov 18.
Liao Z, Gao R, Xu C, Li ZS. Indications and detection, completion, and retention rates of small-bowel capsule endoscopy: a systematic review. Gastrointest Endosc. 2010 Feb;71(2):280-6. doi: 10.1016/j.gie.2009.09.031.
Herrerias JM, Leighton JA, Costamagna G, Infantolino A, Eliakim R, Fischer D, Rubin DT, Manten HD, Scapa E, Morgan DR, Bergwerk AJ, Koslowsky B, Adler SN. Agile patency system eliminates risk of capsule retention in patients with known intestinal strictures who undergo capsule endoscopy. Gastrointest Endosc. 2008 May;67(6):902-9. doi: 10.1016/j.gie.2007.10.063. Epub 2008 Mar 19.
Flamant M, Trang C, Maillard O, Sacher-Huvelin S, Le Rhun M, Galmiche JP, Bourreille A. The prevalence and outcome of jejunal lesions visualized by small bowel capsule endoscopy in Crohn's disease. Inflamm Bowel Dis. 2013 Jun;19(7):1390-6. doi: 10.1097/MIB.0b013e31828133c1.
Kopylov U, Nemeth A, Koulaouzidis A, Makins R, Wild G, Afif W, Bitton A, Johansson GW, Bessissow T, Eliakim R, Toth E, Seidman EG. Small bowel capsule endoscopy in the management of established Crohn's disease: clinical impact, safety, and correlation with inflammatory biomarkers. Inflamm Bowel Dis. 2015 Jan;21(1):93-100. doi: 10.1097/MIB.0000000000000255.
Ladas SD, Triantafyllou K, Spada C, Riccioni ME, Rey JF, Niv Y, Delvaux M, de Franchis R, Costamagna G; ESGE Clinical Guidelines Committee. European Society of Gastrointestinal Endoscopy (ESGE): recommendations (2009) on clinical use of video capsule endoscopy to investigate small-bowel, esophageal and colonic diseases. Endoscopy. 2010 Mar;42(3):220-7. doi: 10.1055/s-0029-1243968. Epub 2010 Mar 1.
Aloi M, Di Nardo G, Romano G, Casciani E, Civitelli F, Oliva S, Viola F, Maccioni F, Gualdi G, Cucchiara S. Magnetic resonance enterography, small-intestine contrast US, and capsule endoscopy to evaluate the small bowel in pediatric Crohn's disease: a prospective, blinded, comparison study. Gastrointest Endosc. 2015 Feb;81(2):420-7. doi: 10.1016/j.gie.2014.07.009. Epub 2014 Aug 10.
Pallotta N, Tomei E, Viscido A, Calabrese E, Marcheggiano A, Caprilli R, Corazziari E. Small intestine contrast ultrasonography: an alternative to radiology in the assessment of small bowel disease. Inflamm Bowel Dis. 2005 Feb;11(2):146-53. doi: 10.1097/00054725-200502000-00008.
Kovanlikaya A, Watson E, Hayward J, Beneck D, Sockolow R, Solomon A, Christos P, Brill PW. Magnetic resonance enterography and wireless capsule endoscopy in the evaluation of patients with inflammatory bowel disease. Clin Imaging. 2013 Jan-Feb;37(1):77-82. doi: 10.1016/j.clinimag.2012.03.011. Epub 2012 Jun 8.
Oliva S, Cucchiara S, Civitelli F, Casciani E, Di Nardo G, Hassan C, Papoff P, Cohen SA. Colon capsule endoscopy compared with other modalities in the evaluation of pediatric Crohn's disease of the small bowel and colon. Gastrointest Endosc. 2016 May;83(5):975-83. doi: 10.1016/j.gie.2015.08.070. Epub 2015 Sep 9.
Kopylov U, Yung DE, Engel T, Vijayan S, Har-Noy O, Katz L, Oliva S, Avni T, Battat R, Eliakim R, Ben-Horin S, Koulaouzidis A. Diagnostic yield of capsule endoscopy versus magnetic resonance enterography and small bowel contrast ultrasound in the evaluation of small bowel Crohn's disease: Systematic review and meta-analysis. Dig Liver Dis. 2017 Aug;49(8):854-863. doi: 10.1016/j.dld.2017.04.013. Epub 2017 Apr 27.
Bryant RV, Winer S, Travis SP, Riddell RH. Systematic review: histological remission in inflammatory bowel disease. Is 'complete' remission the new treatment paradigm? An IOIBD initiative. J Crohns Colitis. 2014 Dec;8(12):1582-97. doi: 10.1016/j.crohns.2014.08.011. Epub 2014 Sep 27.
Giles E, Barclay AR, Chippington S, Wilson DC. Systematic review: MRI enterography for assessment of small bowel involvement in paediatric Crohn's disease. Aliment Pharmacol Ther. 2013 Jun;37(12):1121-31. doi: 10.1111/apt.12323. Epub 2013 May 3.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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13080263
Identifier Type: -
Identifier Source: org_study_id
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