Wireless Capsule Endoscopy in Ulcerative Colitis
Based on the inaccuracies of the current classification scheme for inflammatory bowel disease (IBD), the failure of surgical pouches and the findings of retrospective observational trials to date, we hypothesize that a significant proportion of patients with UC will have small bowel involvement that will result in a change in diagnosis to CD or the recognition of a new phenotype of IBD. The aim of this study is to determine the prevalence of small bowel pathology in patients diagnosed with UC using WCE. This information will aid in the current efforts to re-classify IBD using improved endoscopic and imaging technologies, genetic information and serologic information.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||Prospective Controlled Assessment of Wireless Capsule Endoscopy (WCE) in Ulcerative Colitis (UC)|
- Assess the prevalence of small bowel abnormalities in UC patients compared to controls.
- Ensure safety of subjects by confirming passage of the capsule. [ Designated as safety issue: Yes ]
|Study Start Date:||June 2005|
|Study Completion Date:||November 2008|
|Primary Completion Date:||June 2007 (Final data collection date for primary outcome measure)|
Subjects will undergo both a blood draw and a wireless capsule endoscopy (WCE).
The blood draw will occur in the GI procedure unit on the day of subjects exam.
WCE: Subject will only consume a clear liquid diet after noon the day prior to the exam. No food or beverage consumption any after 10 PM on the day before examination. Not oral medications after 12 AMon the day of exam (8 hours before subject's exam).
Day of exam, subject will report to the endoscopy unit. At that time, subject will be prepared for examination by doctor who will apply a sensor array to the abdomen with adhesive sleeves. In addition, a waist belt device that holds the data recorder will be fitted to subject. Subjects will swallow the capsule endoscope. The capsule endoscope passes naturally through digestive tract while transmitting video images to the data recorder worn on the belt for approximately eight hours. At this point, subjects will be free to leave the University of Chicago hospital until they return eight hours later for disconnection of the recording equipment.
Two hours after ingestion of the capsule, subject will be able to resume a clear liquid diet. Four hours after the study's start time, subject will be able to resume a regular diet ( solid foods). At this time, subject will also be able to resume taking oral medications.
After eight hours, subject will return to the endoscopy suite (DCAM 6H) for disconnection of the recording equipment (sensor array, data recorder, and belt). The time that the capsule was ingested, eating and drinking times, and disconnection time as well as any discomfort subject experienced will be recorded.
Subject will be contacted 72 hours after the examination to confirm passage of the capsule. If they have not reported passage of the capsule with this time, subject will undergo an abdominal radiograph in order to determine whether or not the capsule has passed.
Subjects will be asked to identify a non-relative control (spouses are acceptable) within five years of their age and of similar background without Ulcerative Colitis. There is an Information Handout that participating subjects will give to friends interested in participating. If the subject does not find anyone, they may still participate in this research study. The study staff will try to find someone for them.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00145808
|United States, Illinois|
|University of Chicago|
|Chicago, Illinois, United States, 60637|
|Principal Investigator:||David Rubin, MD||University of Chicago|