IBDCENCT02182947
Capsule Endoscopy in Inflammatory Bowel Disease (IBD) in Children
A study testing Capsule endoscopy in people with IBD, run by Children's Mercy Hospital Kansas City at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 17 years
- Conditions the study is for
- IBD
- What is being tested?
- Capsule endoscopy
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to 30 Dec 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children Mercy Hospital and Clinics
Kansas City, Kansas, 66223
About this study
Official title: Comparison of the Use of Wireless Capsule Endoscopy With Magnetic Resonance Enterography in Children With Inflammatory Bowel Disease
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.
Read the detailed description
Proximal small bowel (SB) involvement in CD is associated with a more aggressive disease course and an increased need for surgery.Therefore, accurate determination of SB involvement in pediatric CD is crucial for optimal patient management. Current clinical guidelines include suggested modalities to identify SB involvement and determine management plans. Available options include small bowel series, computed tomography enterography (CTE), small bowel wireless capsule endoscopy (WCE), gadolinium enhanced MRI imaging (GAD MRI), and small bowel contrast enhanced ultrasound (US). The choice of modality is largely determined by available resources, radiation exposure risk, and physician and institutional preferences. MRE and contrast enhanced US are radiation free, while other radiologic modalities entail a risk of radiation exposure. WCE may entail a risk of capsule retention. The risk of capsule retention resulting in obstruction is increased in the context of stricturing or fistulizing disease in CD and has been estimated at 2.6% but may be greatly mitigated by patency capsule screening.
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
- IBD
- Being tested
- Capsule endoscopy
- Keywords
- Pediatric, Inflammatory Bowel Disease, Wireless capsule endoscopy, MRE, Crohn's Disease, Indeterminant Colitis, Small bowel Crohn's Disease
- Medical subject headings
- Inflammatory Bowel Diseases, Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Capsule endoscopyDevice
Also called Wireless capsule endoscopy, Pillcam from given imaging
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.
| Study group | Role | What they receive |
|---|---|---|
| Endoscopy Imaging | Experimental | Wireless-video capsule endoscopy (WCE) compared to the findings of MRE magnetic resonance enterography in same group of patients. Receives: Device: Capsule endoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 1.5 years
Secondary outcomes (6)
Sensitivity of Magnetic Resonance Enterography (MRE)
The sensitivity MRE in identifying patients with active vs. inactive CD and IC as defined by the Pediatric Crohn's disease activity index (PCDAI).
Measured: 1.5 years
Sensitivity of Wireless Capsule Endoscopy (WCE)
The sensitivity of WCE in identifying patients with active vs. inactive CD and IC as defined by the Pediatric Crohn's disease activity index (PCDAI)
Measured: 1.5 years
Specificity of Magnetic Resonance Enterography (MRE)
The specificity of MRE in identifying patients with active vs. inactive CD and IC as defined by the Pediatric Crohn's disease activity index PCDAI
Measured: 1.5 years
Specificity of Wireless Capsule Endoscopy
The specificity of WCE in identifying patients with active vs. inactive CD and IC as defined by the Pediatric Crohn's disease activity index PCDAI
Measured: 1.5 years
Accuracy of Magnetic Resonance Enterography (MRE)Accuracy
The accuracy of Magnetic Resonance Enterography (MRE) in pediatric patients with known Inflammatory Bowel Disease (IBD) including Crohn's disease (CD) or indeterminate colitis (IC) in reference to pediatric Crohn's disease activity index PCDAI.
Measured: 1.5 years
Accuracy of Wireless Capsule Endoscopy (WCE)
The accuracy of WCE in pediatric patients with known Inflammatory Bowel Disease (IBD) including Crohn's disease (CD) or indeterminate colitis (IC) in reference to pediatric Crohn's disease activity index PCDAI.
Measured: 1.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2014 (estimated)
- Study startAug 2012
- Primary completion30 Dec 2018
- Study completion30 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for IBDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Mercy Hospital Kansas City
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic - MITG
- Responsible party
- Principal investigator, Nadia Hijaz, Children's Mercy Hospital Kansas City
- Investigators
- Nadia M Hijaz, MD, Principal investigator, Children's Mercy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02182947
- Sponsor's protocol ID
- 13080263
- Acronym
- CE
- Status last verified
- Feb 2021
- First submitted
- 30 Jun 2014
- Last updated
- 11 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 15973125North 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.
PubMed 17460505Levi 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.
PubMed 19899197Deviere 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.
PubMed 12929027Jensen 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.
PubMed 21056692Moy 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.
PubMed 19367183Casciani 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.
PubMed 20922391Di 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.
PubMed 21093392Liao 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.
PubMed 20152309Herrerias 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.
PubMed 18355824Flamant 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.
PubMed 23552764Kopylov 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.
PubMed 25517597Ladas 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.
PubMed 20195992Aloi 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.
PubMed 25115363Pallotta 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.
PubMed 15677908
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Use of Wireless Capsule Endoscopy With Magnetic Resonance Enterography in Children With Inflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT02182947
- Acronym / sponsor ID
- CE / 13080263
- Conditions
- IBD
- Keywords
- Pediatric, Inflammatory Bowel Disease, Wireless capsule endoscopy, MRE, Crohn's Disease, Indeterminant Colitis, Small bowel Crohn's Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Children's Mercy Hospital Kansas CityUniversity, hospital or other
- Collaborators
- Medtronic - MITG
- Study start
- Aug 2012 (actual)
- Primary completion
- 30 Dec 2018 (actual)
- Study completion
- 30 Dec 2018 (actual)
- First posted
- 8 Jul 2014 (estimated)
- Results
- Posted 11 Mar 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Proximal small bowel (SB) involvement in CD is associated with a more aggressive disease course and an increased need for surgery.Therefore, accurate determination of SB involvement in pediatric CD is crucial for optimal patient management. Current clinical guidelines include suggested modalities to identify SB involvement and determine management plans. Available options include small bowel series, computed tomography enterography (CTE), small bowel wireless capsule endoscopy (WCE), gadolinium enhanced MRI imaging (GAD MRI), and small bowel contrast enhanced ultrasound (US). The choice of modality is largely determined by available resources, radiation exposure risk, and physician and institutional preferences. MRE and contrast enhanced US are radiation free, while other radiologic modalities entail a risk of radiation exposure. WCE may entail a risk of capsule retention. The risk of capsule retention resulting in obstruction is increased in the context of stricturing or fistulizing disease in CD and has been estimated at 2.6% but may be greatly mitigated by patency capsule screening.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endoscopy Imaging | Experimental | Device: Capsule endoscopyWireless-video capsule endoscopy (WCE) compared to the findings of MRE magnetic resonance enterography in same group of patients. |
Who may qualify
- Ages
- 4 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Capsule endoscopyAlso: Wireless capsule endoscopy, Pillcam from given imagingPediatric 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. | Device | Endoscopy Imaging |
Primary outcome
Diagnostic Yield of Magnetic Resonance Enterography (MRE)
Time frame: 1.5 years
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).
Diagnostic Yield of Wireless Capsule Endoscopy (WCE)
Time frame: 1.5 years
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.
6 secondary outcomes
Sensitivity of Magnetic Resonance Enterography (MRE)
Time frame: 1.5 years
Sensitivity of Wireless Capsule Endoscopy (WCE)
Time frame: 1.5 years
Specificity of Magnetic Resonance Enterography (MRE)
Time frame: 1.5 years
Specificity of Wireless Capsule Endoscopy
Time frame: 1.5 years
Accuracy of Magnetic Resonance Enterography (MRE)Accuracy
Time frame: 1.5 years
Accuracy of Wireless Capsule Endoscopy (WCE)
Time frame: 1.5 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 15973125Cuffari 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.
- Background: PubMed 17460505North 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.
- Background: PubMed 19899197Levi 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.
- Background: PubMed 12929027Deviere 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.
- Background: PubMed 21056692Jensen 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.
- Background: PubMed 19367183Moy 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.
- Background: PubMed 20922391Casciani 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.
- Background: PubMed 21093392Di 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.
- Background: PubMed 20152309Liao 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.
- Background: PubMed 18355824Herrerias 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.
- Background: PubMed 23552764Flamant 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.
- Background: PubMed 25517597Kopylov 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nadia M Hijaz, MD principal investigator
Children's Mercy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Capsule endoscopy in people with IBD, run by Children's Mercy Hospital Kansas City at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic Yield of Magnetic Resonance Enterography (MRE) (time frame: 1.5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02182947, which also lists 20 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2021.