PillCam Colon Capsule Endoscopy for Ulcerative Colitis

Completed

• Conditions: Ulcerative Colitis

• Registration Number: NCT01467609
• Lead Sponsor: Shanghai Jiao Tong University School of Medicine

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2009-07
• Primary Completion: 2010-07
• Study Completion: 2010-11
• Study First Submitted: 2011-10-20
• Status Verified: 2011-11
• Study First Submitted QC: 2011-11-04
• Last Update Submitted: 2011-11-04
• Study First Posted: 2011-11-08
• Last Update Posted: 2011-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Adult patients (aged 18-70)
• Ulcerative Colitis history
• Suffering from symptoms such as hematochezia, diarrhea or abdominal pain

Exclusion Criteria

• Patients with a high risk for capsule retention (such as intestinal diverticula, acute abdominal pain without regular defecation indicating intestinal obstruction or a history of abdominal operation or intestinal reconstructed operation),
• Patients allergic to sodium phosphate or polyethylene glycol (PEG) solution,
• Patients with a history of Crohn's disease
• Patients with serious systematic diseases such as congestive heart failure, renal failure or severe liver disease.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluate the accuracy of PCC endoscopy in the survey of ulcerative colitis compared with conventional compared with conventional		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)

Secondary Outcome Measures

Name	Time	Method
the Mayo score of each case
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)
clinical data such as age, gender,chief complaint
the quality of colonic preparation		4 grades contain excellent, good, fair and poor