Comparison of the Use of Wireless Capsule Endoscopy With Magnetic Resonance Enterography in Children With Inflammatory Bowel Disease
Phase: NA
Conditions: IBD
Sponsor: Children's Mercy Hospital Kansas City

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Comparison of the use of Wireless Capsule Endoscopy with 
Magnetic Resonance Enterography in Children with 
Inflammatory Bowel Disease 
 
 
 
 
NCT # 02182947  
March 20, 2014 
Revised January 31, 2017  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Comparison of the use of Wireless Capsule Endoscopy with 
Magnetic Resonance Enterography in Children with 
Inflammatory Bowel Disease 
 
 
Principal Investigator: 
Nadia M Hijaz, MD, Assistant professor of Pediatric, Division of Gastroenterology 
Hepatology and Nutrition, University of Missouri Kansas City, Children Mercy Hospital 
Kansas City, 2401 Gillham Road, Kansas City, MO 64108 USA nmhijaz@cmh.edu  
 
Co-Investigators: 
Thomas M Attard, MD, Professor, Division of Gastroenterology Hepatology and 
Nutrition, University of Missouri Kansas City, Children Mercy Hospital Kansas City, 
2401 Gillham Road, Kansas City, MO, 64108 USA tmattard@cmh.edu 
 
Jennifer M Colombo, MD, Associate Professor, Division of Gastroenterology Hepatology 
and Nutrition, University of Missouri Kansas City, Children Mercy Hospital Kansas City, 
2401 Gillham Road, Kansas City, MO, 64108, USA jmcolombo@cmh.edu   
 
Neil J Mardis, MD, Pediatric Radiologist, Division of Radiology, University of Missouri 
Kansas City, Children Mercy Hospital Kansas City, 2401 Gillham Road, Kansas City, 
MO 64108 USA  njmardis@cmh.edu 
 
Craig A Friesen, MD, Professor, Division of Gastroenterology Hepatology and Nutrition, 
University of Missouri Kansas City, Children Mercy Hospital Kansas City, 2401 Gillham 
Road, Kansas City, MO USA  64108, USA  cfriesen@cmh.edu. 
 
 
 
Study Site(s): Children’s Mercy Hospital 
 
Protocol Version: (2.0)                          Protocol Date:  March 20, 2014 
1. 
STUDY OBJECTIVES/HYPOTHESIS 
Primary Objective(s) 
Primary aim: Compare the diagnostic yield of Magnetic Resonance Enterography (MRE) 
with Small-Bowel Capsule Endoscopy (SBCE) in pediatric patients with known 

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Inflammatory Bowel Disease (IBD) including Crohn’s disease (CD) or indeterminate 
colitis (IC). 
Secondary Objective(s) 
  
1. To determine the detection rate of small bowel disease / complications, subjected 
to a strategy of Wireless Capsule Endoscopy (WCE) – small bowel screening / 
surveillance vs MRE in a pediatric tertiary medical institution. 
2. Compare sensitivity and specificity of both MRE and WCE in identifying patients 
with active vs. inactive CD and IC as defined by the Pediatric Crohn’s disease 
activity index. 
3. To correlate the findings detected on WCE by Lewis score with Crohn’s disease 
activity index. 
2. 
BACKGROUND 
 
Crohn’s Disease CD represents a chronic idiopathic disorder primarily involving 
the gastrointestinal tract. Although any part of the gastrointestinal tract can be involved, 
the most common pattern in paediatric patients is ileocecal involvement. More proximal 
small intestinal involvement is more common in pediatric patients with a prevalence of 
up to 20%[1]. The clinical presentation and sequelae of small intestinal involvement in 
Crohn’s Disease is varied and include nutritional sequelae resulting in growth delay and 
including iron deficiency anemia, stricture formation, obscure abdominal pain and 
eventually obstruction[1,2]. Small intestinal screening in suspected Crohn’s Disease and 
periodic small intestinal surveillance in known cases is the current accepted standard of 
care [1]. There are several modalities that can be employed toward visualizing the small 
intestine although there is no gold standard[1]. Options include contrast studies including 
small bowel series and computed tomography enterography (CTE). Gadolinium enhanced 
MRI imaging (GAD MRI) of the abdomen and small bowel enema are technically more 
demanding but may be more sensitive in early disease.  
 
There is growing concern with recurrent radiation exposure particularly from 
routine radiologic modalities in children [3], this is especially relevant in pediatric 
Crohn’s Disease in so far as CT entercolysis abdomen and small bowel series are often 
seen as complementary [3]. Although small bowel series is accepted as a routine 
diagnostic modality in pediatric IBD if fluoroscopy time is kept to a minimum, its 
limitations are well defined and are especially relevant in the early stages of IBD wherein 
fistulising, stricturing disease is less common. Magnetic resonance enterography (MRE) 
has a diagnostic effectiveness comparable to other radiological modalities for evaluation 
of adult patients with CD, [1,2]but without radiation exposure. However it is limited by 
expense, the availability of the requisite equipment and software, need for sedation in 
pediatric population, limited expertise in accurate interpretation especially in early 
lesions such as are more common in pediatric IBD, and overall insensitivity to early 
mucosal lesions including vascular abnormalities.  
 

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Alternative modalities for small bowel imaging are being studied and include the 
routine use of wireless-video capsule endoscopy (WCE) which allows visualization of the 
small-bowel mucosal lesions in Crohn’s disease [4]. Because the risk for capsule 
retention in suspected or established Crohn’s disease is significantly increased; in some 
series up to 13%; pre WCE small bowel imaging or patency capsule has become standard 
of care.  
 
The main indications for WCE in Crohn’s disease are to establish the diagnosis, to 
assess disease prognosis, disease activity, and mucosal healing post therapy, and to define 
the extent and severity of disease [5]. A small, prospective study of 27 patients suspected 
to have Crohn’s disease, revealed a sensitivity of 93% and specificity of 84% for the 
WCE examination compared to surgical and enteroscopic tissue samples, and 
demonstrated a significant change in their management [6]. Another prospective 
randomized blinded study adults (N = 21) reported the sensitivity and specificity of CD 
in terminal ileum were 100% and 91% by WCE[7]. Jenson suggested WCE as first line 
modality for detection of small bowel CD beyond the reach of colonoscopy [7]. In adults 
with known CD, Karoui et al evaluated WCE in a prospective study (N = 20) comparing 
it to radiological techniques and concluded that WCE is more accurate in detection of 
small bowel lesions in CD[8]. 
 
In a small retrospective study (N=7), most older children and adolescents with 
unexplained growth failure and normal small bowel series were found to have Crohn’s 
disease involving the small intestine [9]. A recent prospective study performed in 60 
pediatric patients with suspected crohns showed both MRE and WCE appeared 
complementary methods for the detection of Crohn’s disease in suspected CD patients. 
Both have a high degree of accuracy, sensitivity, and specificity at 98.3%, 100%, 97.6%, 
and 91.9%, 90.9%, 92.3%, respectively [10].  Another large prospective study in  children 
(N=117) with established or suspected CD demonstrate a statically significant diagnostic 
yield of WCE in reclassifying indeterminate colitis IC into CD (60%), detection of CD 
lesions in known CD (41%) and establishing new diagnosis in suspected CD(50%) 
compared to other radiological modalities[11]. 
 
Overall tolerance and safety: WCE is safe in children approximately 9 years of 
age and older, endoscopic placement is feasible in individuals refusing or unable to 
swallow the capsule but adds to the potential morbidity and expense of the procedure. 
WCE has been safely performed in children as small as 11.5 kg [4]. Jensen and 
colleagues studied the factors associated with incomplete WCE studies and their 
diagnostic yield in pediatric patients. In this study, 22% of the WCE studies were 
incomplete, and in 12 (44%) of these were normal pre-WCE radiologic findings [4].   
 
WCE should be used with caution and most likely contraindicated in patients with 
known swallowing disorders, gastrointestinal obstruction and fistulas. The risk for WCE 
retention (which is defined as capsule remains in digestive tract for a minimum of 2 
weeks or it requires direct intervention to aid in its passage) in Crohn’s disease patients is 
estimated to be 5%–13% [12]. Even though Crohns disease is reported to have the most 

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common retention rate it is reported in metanalysis that retention rate is 2.6% in all 
prospective and retrospective studies [13]. 
 
Atay and colleagues investigated the risk factors for capsule retention in their 
cohort (n = 207) of pediatric patients studied by WCE[14]. Capsule retention complicated 
1.4% of studies; all in known Crohn’s patients. The risk in known CD patients was 
therefore 5.2%, and rose to 37% if there had been a prior small bowel series showing 
small bowel disease, and to 43% if the patient’s body mass index was less than the 5th 
percentile, presumably indicative of more severe, longstanding small bowel involvement 
[14]. 
The Patency Capsule (Agile ®) was developed, tested, and shown to greatly 
curtail the possibility of small bowel capsule retention and therefore obviate the need for 
surgery[15].  A pre-WCE, patency capsule (PC) strategy has completely removed the 
incidence of capsule retention[15]. The caveat to PC testing is that it also impacts the 
utility of WCE overall in so far as a proportion of patients cannot thus be studied (failed 
PC passage).  The Patency capsule is identical in shape and size to the actual WCE 
device but in the presence of small intestinal enzymes it will dissolve starting at 30 hours 
post ingestion, thus slow passage or retention of PC in the small bowel signals a risk of 
capsule retention and are usually interpreted as a contraindication for WCE.[16]  
 
The safety of PC was evaluated in a multicenter clinical trial (N=106) with known 
Crohn’s disease and intestinal strictures which showed that all cases had a complete 
passage of WCE if patency capsule proved patency[15] . Adverse events of PC were 
reported in 17/106 patients such as abdominal pain was managed with 
conservative management. One case developed obstruction and underwent surgery 
which seems unrelated to the patency capsule because it was not retained at the 
time of surgery (1/106) [15]. Another retrospective study by Cohen showed that 
after successful passage of the patency capsule in 19 patients, who proceed to have 
WCE after one week with one patient experiencing capsule retention[17]. The results 
of the study led to the diagnosis of CD and the patient subsequently underwent a needed 
ileocecal resection [17]. 
 
RATIONALE 
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. 
 
3. 
 STUDY DESIGN 
• Prospective single blinded comparison of a cohort of pediatric patients with 
indeterminate colitis (IC) or Crohn's disease (CD) who are scheduled to undergo 

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routine small bowel screening or surveillance using MRE. Subjects will swallow a 
patency capsule (PC) to study bowel patency. If MRE shows stenosis or stricture 
subject and caregivers will be given the opportunity to continue with the study or 
withdraw. 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. Both modalities diagnostic yields will be 
compared to detect Crohn’s disease lesions/complications and correlate the 
findings with Pediatric Crohn’s Disease Activity Index (CDAI).  
4. 
TARGET STUDY POPLUATION SPECIFICS 
 
Study participants (n=50) ages 4 – 17.99 years of age will be recruited for this 
study. Patients will be identified for recruitment after an initial evaluation in 
gastroenterology clinic at Children’s Mercy (CM), if they are diagnosed with IBD and 
planned to have MRE as part of standard of care for clinical indication to evaluate small 
bowel disease.  
Inclusion Criteria; 
• 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 
Exclusion Criteria: 
• 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.  
 
5. 
STUDY PROCEDURES 
• Prior to MRE visit: 
o The provider ordering the MRE will contact a member of the study team to let 
them know an MRE for a patient has been scheduled.  
o Team members will have the option of calling the parent/authorized 
representative of the family to ask if they would like to hear about the study. If 
yes, the team member will explain the study and follow protocol for telephone 
consent or agree to meet with the family when the patient comes in for his/her 
MRE.  

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• Standard of Care MRE visit:  
o At the MRE procedure visit, if not previously consented, the subject and 
family will be approached by a member of the study team to explain the study 
and ask if they would like to participate. If a subject is unable to stay after 
MRE to complete patency capsule procedures, the family can choose to return 
in the next 1-2 days to any CMH GI location with study staff to complete the 
procedure.  
• Post Consent: 
o Subject will have lab draw for: Hemoglobin/Hematocrit (Hgb/Hct), 
erythrocyte sedimentation rate (ESR), Albumin. 
▪ Lab draw at time of standard of care IV placement for MRE if possible 
▪ If not possible to complete at MRE subject may have at the time of    
      patency capsule or WCE visit. 
▪ If the subject has had these labs drawn for standard of care in the last 2   
      weeks, those values will be used in place of this lab draw 
o  Patency capsule (performed as a part of the research study): A dissolvable 
capsule the same size as the PillCam SB capsule, with a radio frequency 
identification (RFID) tag (size 3mm x 13mm) packed in a lactose and barium 
powder. If the capsule is retained more than 80 hours it will dissolve into 
small pieces that can pass naturally through the GI tract after 2-5 days. Due 
to its ability to dissolve it is unlikely that if the capsule is retained that it will 
cause any further complications. 
o Subject will swallow the capsule. They will then follow the below schedule. 
▪ 0-2 hours nothing to eat or drink 
▪ 2-4 hours clear liquid only 
▪ 4+ hours may eat and drink freely 
▪ Miralax dose at the time the child can eat: Less than 5 years of age 
2 doses (34 grams), 5-10 years of age 3 doses (51 grams), greater 
than 10 years of age 4 doses (68 grams). 
▪ Due to the age range of subjects in the study they will likely be in school 
during the time they are enrolled in the study. To allow for greater 
flexibility for families. The patency capsule can be swallowed at home or  
 
with a parent/caregiver at school during the lunch period. The patient or 
caregiver must record the exact time the pill is swallowed to calculate 

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time till x-ray. This will allow for the subsequent miralax dose and any 
necessary x-rays to take place after school hours. 
o Subjects should not be around electromagnetic fields while PC procedure is 
performed 
o Subject will receive Miralax and instructions for WCE home prep. 
• 
Post Patency Capsule Swallow 
o A follow up phone call will take place with the subject and family the day 
following patency capsule ingestion. Subjects will return to CM radiology for 
an abdominal x-ray within 28-40 hours, as close as possible to 30 hours after 
swallowing the patency capsule unless they report to the study team that they 
visibly saw the excreted capsule. If the patency capsule has passed through the 
bowel then the subject will continue with WCE procedures. 
o The study doctor or the subjects regular GI doctor or an appropriate delegate 
will discuss the results of MRE and patency capsule with the subject and 
guardian to decide if is a possible increased risk of retention and families will 
be able to decide if they would like to continue with study procedures. GI 
providers will be added to the MARS electronic IRB submission form and 
listed as study staff when they refer a subject so they are identified as being 
able to participate in these study procedures. 
• 
WCE Visit 
o 
The subject will return to the GI clinic to complete the WCE 5 days (± 2 
days) from the time of patency capsule ingestion. Subject dietary restrictions 
the day before the wireless capsule endoscopy (WCE) visit.  
▪ To allow for greater flexibility for those subjects who are in school at the 
time of study procedures. The miralax prep may be started after school 
however the no solid foods after noon must still be observed. 
▪ Subject will fast for 8 hours overnight. 
 
o WCE visit (approximately 1 hour) - performed as a part of the research study. 
 
▪ The WCE used in this study is the PillCam SB video capsule (Given  
      Imaging, Israel) that measures 11mm × 26mm and weighs less than 4 g.  
▪ Subjects will wear a belt sensor around their waist and a recording device     
attached to it for the duration of the WCE study. device  

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▪ Subject will be asked questions about any symptoms and/or new      
      medications. 
▪ Subject will swallow the capsule in GI procedure room. 
▪ Subjects should not be around electromagnetic fields while WCE 
procedure is performed 
▪ Subject may drink clear liquids 3 hours after ingesting the capsule 
▪ Subject may eat solid foods 6 hours after ingesting the capsule, 
respectively. 
▪ Subjects will be asked to return to the GI procedure room to return the belt 
sensor 8-12 hours after ingesting the WCE 
At times due to Crohn’s disease a portion of the bowel can become inflamed and 
narrowed. These stenosed/strictured areas are not often easily identified until a patient 
has symptoms of bowel obstruction. It is possible that the capsule may identify these 
areas because it is not able to pass through the decreased space in the lumen. If the family 
or subject does not visually see the capsule pass within 2 weeks from the time of capsule 
ingestion, then an x-ray will be performed to assess if it is retained in the bowel. If the 
capsule is retained, the PI or Sub-I will notify the subject’s primary GI physician about 
the finding and medical management will be attempted to reduce the subject’s 
inflammation so that the capsule may pass through. In some cases the capsule may 
identify such a diseased portion of the bowel that it needs to be surgically removed. This 
capsule retention due to a strictured portion of the bowel will not be considered an 
adverse event. It will be considered an incidental finding of the subject’s disease process. 
The subject and their 3rd party payor will be responsible for the treatment of these 
incidental findings. 
6. 
DATA COLLECTION 
 
Data Collection Procedures 
• The subject’s medical record will be reviewed for data collection to include but 
not limited to, subject demographics, medical and surgical history, imaging 
results initial disease presentation and patient current clinical status. Data will be 
collected on a separate paper data collection form. 
• The capsule images will be independently interpreted by the PI initially and then 
confirmed by two gastroenterologists with 4 - 10 years of experience in capsule 
endoscopy. The results will be reported in the subject’s medical record as they 
would be for standard of care in compliance with the CMH policy on medical 
record documentation of research subjects. The subjects regular GI provider will 
review the results of the WCE and consider the results when making decisions 
about the subjects treatment plan. We will be using the capsule endoscopy data 
collection form including the Lewis scoring system that is automatically 

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calculated and included in the RAPID® software. Lewis score is a WCE ranking 
of inflammatory activity into three levels based on erythema, stenosis, edema and 
erosions in small intestinal tertiles: 1) no disease or clinically insignificant disease 
(LS<135); 2) mild disease (135≤LS≤790); and 3) moderate or severe disease 
(LS>790). 
• The study will be considered negative if no abnormalities were seen and as 
positive if clear abnormalities of the SB mucosa (i.e. ulcerations, erosions, polyps, 
vascular lesions, and bleeding lesions) were observed. White lesions within a 
crater with surrounding erythema were considered ulcers, whereas small 
superficial white lesions, even with surrounding erythema, were considered 
erosions.  If no abnormalities or non-specific findings (such as erythematous spots 
or mucosal breaks) were seen the examination was considered non-specific or 
normal. 
• The examiners of WCE and MRE will be blinded to each other’s findings but will 
be aware of the patient’s history and laboratory data. 
• To reduce variation in MRE readings, one radiologist will retrospectively review 
the MRE for all subjects to provide a consistent assessment of the extent of the 
subjects’ disease. 
 Records to be kept 
Information will be collected on a paper data collection sheet and entered in an electronic 
database. Additionally if a research team member chooses they may complete the data 
collection form electronically by typing results into the electronic word document version 
of the data collection sheet and saving it to the internal CMH server. Data collection 
forms will be identified only by assigned subject study ID, date of service and will be 
retained indefinitely. The electronic database will only retain assigned subject study ID 
numbers and will be retained indefinitely. An electronic master subject list will include 
subject name, MRN, dates of service and study assigned ID number. The electronic 
master subject list will be retained indefinitely. A pre-recruitment log with patient name, 
MRN and date of MRE will be used to track and keep record of those subjects 
approached for study participation. The pre-recruitment log will be destroyed at the time 
enrollment is completed. The WCE procedure uses a software installed on the hard drive 
of the password protected CMH GI procedure room computer. The images from the study 
and subject name, MRN, and date of birth will be retained indefinitely on the hard drive. 
The information entered into the medical record will be retained indefinitely. 
Secure Storage of Data 
 
Paper/physical Documents: These documents will be stored in a file cabinet in the locked 
research room in the GI clinic:  
• Signed Permission/Assent/Consent  
• Paper Data Collection Forms  
 

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Electronic Documents: These documents will be kept on the secure internal CMH server, 
in a restricted access folder: 
• Data Collection form 
• Master Participant List 
• Pre-recruitment Log 
• Data Collection Database  
7. 
STUDY DURATION/STUDY TIMELINE 
 
Stage 1: recruitment and study procedures, fall 2013-Fall 2014 
Stage 2: data analysis, fall 2014- winter 2014 
Stage 3: publication, 2015 
8. 
STATISTICAL CONSIDERATIONS 
Measures 
 
1. Detection rate of upper intestinal lesions in known IBD – CD undergoing WCE vs 
radiologic modality. 
2. Definitive diagnosis of SB involvement of patients undergoing WCE vs 
radiologic modality in indeterminate IBD. 
3. Complication rate for WCE vs 1st radiologic testing 
4. Retention rate of WCE 
5. The Crohn’s disease activity index and it is relation with the findings on both 
modalities 
6. Lewis score on WCE 
 
 
Sample size determination 
 
With a sample size of 34 participants we will have 80% power probability to 
detect the 23 % difference in IBD small intestinal MRE findings and WCE detection rate 
similar to previously reported pediatric studies [11]. This determination uses a Chi-
Square test and a two-sided significance level of 0.05. Subjects whose MRE results show 
findings that are contraindicated with WCE will be considered screen failures. We 
anticipate around 20% screen failure rate and intend to recruit 40 subjects to obtain a 
sample size of 34 evaluable subjects. 
   
 
Data Analyses 
 
The disease activity detection rate of MRE and WCE will be compared using McNemar’s 
test and Chi square test. The sensitivity and specificity of both tests will be calculated 
based on a gold standard of classifying disease activity using Crohn’s disease activity 
index (CDAI). The person correlation coefficient or spearman rank correlation coefficient 

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will be utilized to assess agreement between lewis capsule endoscopy score and CDAI. 
All p values will be 2 sided with statistical significance evaluated at 0.5 alpha level.  
HUMAN SUBJECTS   
Institutional Review Board (IRB) Review and Informed Consent 
This protocol, and any subsequent modifications, will be reviewed and approved by the 
Pediatric IRB at The Children’s Mercy Hospital & Clinics.   
We request a partial Waiver of HIPAA Authorization for pre-recruitment activities. 
 
Potential participants will be identified at the time of a clinic appointment or prior to their 
scheduled MRE appointment in radiology. IBD program coordinators or GI providers 
will notify a research staff member of a potential participant’s eligibility. The family will 
be approached at a clinic visit about participation. If the research staff is notified at a time 
that the family is not in the clinic a member of the study team will call the family to 
introduce the study to them briefly and ask if they can talk with them about the study 
prior to their MRE. A recruitment flyer and permission assent form can be sent to the 
family prior to the appointment via e-mail, fax or postal mail should they request it. The 
recruitment flyer will also be made available in the GI Clinic. 
 
Prior to drawing any blood or performing any other procedures related to this study, the 
permission/assent form or consent form will be reviewed carefully with the participant 
(and parent) in person or by telephone in extenuating circumstances (i.e. out-of-state non-
custodial parent, divorce, or separation).  
 
Telephone consenting may be necessary for this study due to fasting procedures required 
prior to the subjects standard of care visit so the subject may continue at the same visit 
with research procedures. All questions will be answered and signatures will be obtained 
by study staff form the parent before procedures begin on the child. The PI will ensure 
the procedures for securing telephone consent are followed. 
Subject Confidentiality 
 
Paper/physical Documents: These documents will be stored in a file cabinet in the locked 
research room in the GI clinic:  
• Signed Permission/Assent/Consent – will contain subject and caregiver name and 
subject MRN, date of consent, retained indefinitely. 
 
• Paper Data Collection Forms – subject study ID, date of service, retained 
indefinitely 
 
Electronic Documents: These documents will be kept on the secure internal CMH server, 
in a restricted access folder): 
 
• Data Collection Forms – subject study ID, date of service, retained indefinitely 

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• Master Participant List - subject name, MRN, date of service, assigned study ID 
number, retained indefinitely. 
• Pre-recruitment Log – subject name, MRN, date of MRE, deleted upon 
completion of enrollment. 
• Data Collection Database - de-identified, retained indefinitely 
WCE software - The images from the study and subject name, MRN, date of service, 
capsule ID number and date of birth will be retained indefinitely on the hard drive. The 
information entered into the medical record will be retained indefinitely. 
Study Modification/Discontinuation 
The study may be modified or discontinued at any time by the IRB, the OHRP, the FDA 
or other Government agencies as part of their duties to ensure that research subjects are 
protected. 
9. 
PUBLICATION OF RESEARCH FINDINGS 
 
Results are intended to be presented at the national Gastroenterology and Inflammatory 
Bowel Disease conferences.  
Results are intended to be published in the Gastroenterology journals. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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10. REFERENCES 
1. Cuffari C, Dubinsky M, Darbari A, Sena L, and Baldassano R. Crohn’s Jejunoileitis: 
The Pediatrician’s Perspective on Diagnosis and Management. Inflamm Bowel Dis 
2005;11(7):696-704. 
 
2. 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 Journal of Pediatric Gastroenterology and Nutrition 2007; 44: 653-674 
 
3. Levi Z, Fraser E, Krongrad R, et al. Factors associated with radiation exposure in 
patients with inflammatory bowel disease. G Aliment Pharmacol Ther. 2009; 30:1128-
1136. 
 
4. Jensen MK, Tipnis N, Bajorunaite R, Sheth M, Sato T, Noel R. Capsule endoscopy 
performed across the pediatric age range: indications, incomplete studies, and utility in 
management of inflammatory bowel disease. Gastrointest Endosc. 2010 ;72:95-102. 
 
5. Ladas SD, Triantafyllou K, Spada C, et al . European Society of Gastrointestinal 
Endoscopy (ESGE): recommendations (2009) on clinical use of video capsule endoscopy 
to investigate small-bowel, esophageal and colonic diseases; ESGE Clinical Guidelines 
Committee. Endoscopy. 2010 ;42:220-227. 
 
6. Girelli C, Porta P, Malacrida V, Barzaghi F, Rocca F. Clinical outcome of patients 
examined by capsule endoscopy for suspected small bowel Crohn's disease. Dig Liver 
Dis. 2007;39:148–154. 
 
7. Jensen MD , Nathan T, Rafaelsen SR, Kjeldsen J. Diagnostic acuuracy of capsule 
endoscopy for small bowel Crohns disease is superior to that of MR enterography or CT 
enterography. Clin Gastroenterol Hepatol. 2011;9:124-129. 
 
8. Karoui S, Ouerdiane S, Nouira K, et al. Evaluation of small bowel involvement in 
crohns disease by small bowel. Bowel  videocapsule a prospective comparative study 
with Computed Tomography enteroclysis and small bowel radiography. Tunis Med. 
2011;89 :445-451. 
 
9. Moy L, Levine J. Capsule endoscopy in the evaluation of patients with unexplained 
growth failure. J Pediatr Gastroenterol Nutr. 2009 ; 48(5):647-650. 
 
10. Casciani E, Masselli G, Di Nardo G,et al. MR enterography versus capsule endoscopy 
in paediatric patients with suspected Crohn’s disease. Eur Radiol. 2011; 21:823–831. 
 
11. Di Nardo G, Oliva S, Ferrari F, et al. Usefulness of wireless capsule endoscopy in 
pediatric inflammatory bowel disease. Dig and Liver Dis. 2011;43: 220-224. 
 

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12. Cheifetz A, Korenbluth A, Legnani P, et al. The risk of retention of the capsule 
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