Capsule Endoscopy in Inflammatory Bowel Disease (IBD) in Children

NCT02182947 | Completed Results DMC

• 1 other identifier: 13080263
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

Most of the studies evaluating the roles of MRE and WCE conducted in pediatric patients have been retrospective with the main goal of making a diagnosis in patients with suspected IBD. The current study is the first prospective study in children with known IBD assessing the roles of MRE and WCE in identifying disease exacerbation. This study will help to identify if capsule endoscopy is superior or complementary to MRE in the evaluation of suspected disease exacerbation in IBD patients.

Conditions

IBD

Keywords

Pediatric; Inflammatory Bowel Disease; Wireless capsule endoscopy; MRE; Crohn's Disease; Indeterminant Colitis; Small bowel Crohn's Disease

Outcome Measures

Primary Outcomes (2)

• Diagnostic Yield of Magnetic Resonance Enterography (MRE)

  The reported positive Magnetic Resonance Enterography (MRE) studies percentage in pediatric patients with known Inflammatory Bowel Disease (IBD) including Crohn's disease (CD) or indeterminate colitis (IC). Diagnostic yield DY of MRE that is the ability of a test to show positive findings to diagnose small bowel Crohns disease based on specified criteria used in the study.The study is positive if it has score of \>3 of radiological findings of (SB wall thickness, SB wall enhancement , mucosal and serosal enhancement suggestive of mesenteric fatty infiltration, strictures, comb sign which is increased mesenteric vascularity adjacent to the inflamed bowel loop, reactive mesenteric lymphadenopathy, the presence of fistula, stricture or abscess and the number of SB segments involved).

  1.5 years

• Diagnostic Yield of Wireless Capsule Endoscopy (WCE)

  The reported positive Wireless Capsule Endoscopy (WCE) percentage in pediatric patients with known Inflammatory Bowel Disease (IBD) including Crohn's disease (CD) or indeterminate colitis (IC). Diagnostic yield of wireless capsule endoscopy is the ability of this test to detect abnormalities and diagnose positive small bowel crohns disease. The positive (or active) WCE is defined if clear abnormalities of the SB mucosa (ulcerations \>3, erosions, polyps, vascular lesions, and bleeding lesions). White lesions within a crater with surrounding erythema were considered ulcers, whereas small superficial white lesions, even with surrounding erythema, were considered erosions.

  1.5 years

Secondary Outcomes (6)

• Sensitivity of Magnetic Resonance Enterography (MRE)

  1.5 years

• Sensitivity of Wireless Capsule Endoscopy (WCE)

  1.5 years

• Specificity of Magnetic Resonance Enterography (MRE)

  1.5 years

• Specificity of Wireless Capsule Endoscopy

  1.5 years

• Accuracy of Magnetic Resonance Enterography (MRE)Accuracy

  1.5 years

Study Arms (1)

Endoscopy Imaging

EXPERIMENTAL

Wireless-video capsule endoscopy (WCE) compared to the findings of MRE magnetic resonance enterography in same group of patients.

Device: Capsule endoscopy

Interventions

Capsule endoscopy DEVICE

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.

Also known as: Wireless capsule endoscopy, Pillcam from given imaging

Endoscopy Imaging

Eligibility Criteria

• Age: 4 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Patients aged 4 to 17.99 years at time of investigation
• 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

You may not qualify if:

• IBD diagnosis not established
• 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.

Sponsors & Collaborators

• Children's Mercy Hospital Kansas City: lead
• Medtronic - MITG: collaborator

Study Sites (1)

Children Mercy Hospital and Clinics

Kansas City, Kansas, 66223, United States

Location

Related Publications (20)

• 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.

  PMID: 15973125 BACKGROUND

• 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.

  PMID: 17460505 BACKGROUND

• 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.

  PMID: 19899197 BACKGROUND

• 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.

  PMID: 12929027 BACKGROUND

• 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.

  PMID: 21056692 BACKGROUND

• 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.

  PMID: 19367183 BACKGROUND

• 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.

  PMID: 20922391 BACKGROUND

• 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.

  PMID: 21093392 BACKGROUND

• 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.

  PMID: 20152309 BACKGROUND

• 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.

  PMID: 18355824 BACKGROUND

• 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.

  PMID: 23552764 BACKGROUND

• 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.

  PMID: 25517597 BACKGROUND

• 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.

  PMID: 20195992 BACKGROUND

• 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.

  PMID: 25115363 BACKGROUND

• 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.

  PMID: 15677908 BACKGROUND

• 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.

  PMID: 23206611 BACKGROUND

• 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.

  PMID: 26363334 BACKGROUND

• 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.

  PMID: 28512034 BACKGROUND

• 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.

  PMID: 25267173 BACKGROUND

• 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.

  PMID: 23638954 BACKGROUND

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Crohn Disease

Interventions

Capsule Endoscopy; Endoscopy

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

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

Limitations and Caveats

Small patient population limits the ability to largely generalize these results.

Results Point of Contact

• Title: Nadia Hijaz
• Organization: Children's Mercy Hospital

nmhijaz@cmh.edu

3139204958

Study Officials

• Nadia M Hijaz, MD

  Children's Mercy

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: June 30, 2014
• First Posted: July 8, 2014
• Study Start: August 1, 2012
• Primary Completion: December 30, 2018
• Study Completion: December 30, 2018
• Last Updated: March 11, 2021
• Results First Posted: March 11, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)