PillCam Colon Capsule Endoscopy for Ulcerative Colitis
Pillcam colon capsule (PCC) endoscopy is a novel strategy tool to inspect colon mucosa. The aim of the present study is to evaluate if PCC endoscopy is able to precisely investigate patients with ulcerative colitis and reach high consistency to conventional colonoscopy.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||PillCam Colon Capsule Endoscopy Versus Conventional Colonoscopy for the Detection of the Severity and Extent of Ulcerative Colitis|
- Evaluate the accuracy of PCC endoscopy in the survey of ulcerative colitis compared with conventional compared with conventional [ Designated as safety issue: No ]the severity of patients investigated by PCC endoscopy and conventional colonoscopy the extent of evolved lesions extent investigated by PCC endoscopy and conventional colonoscopy the safety of PCC endoscopy course (eg: adverse events during bowel preparation and the course; the completion rate)
- the gastrointestinal transit time (transit time from ingestion to excretion), cecum arrival time (transit time from ingestion to the cecum), and colon residence time (transit time from the arrival in the cecum to excretion) [ Designated as safety issue: Yes ]
- clinical data such as age, gender,chief complaint
- the Mayo score of each case
- the quality of colonic preparation4 grades contain excellent, good, fair and poor
Biospecimen Retention: Samples Without DNA
regular biopsy was taken during conventional colonoscopy according to the activity and position of ulcerative colitis involved.
|Study Start Date:||July 2009|
|Study Completion Date:||November 2010|
|Primary Completion Date:||July 2010 (Final data collection date for primary outcome measure)|
Symptomatic patients with confirmed ulcerative colitis (UC) were enrolled in this prospective single-center study. No sooner had patients gone through Pillcam colon capsule (PCC) endoscopy solution than they got conventional colonoscopy which is recognized as the "gold standard" examination technique. The extent of mucosal damage and inflammatory lesions during both modalities were recorded for comparison. In addition, the regimen of bowel preparation, completion rate, colonic cleanliness, compliance or adverse events were analyzed.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01467609
|Principal Investigator:||zhi zheng Ge, MD. Ph.D||Clinical Professor of Gastroenterology Department, Shanghai Renji Hospital; Director, Head of Digestive Endoscopy Department, Shanghai Renji Hospital|