The Utility of Second Generation Colon Capsule Endoscopy in Ulcerative Colitis

The Chinese University of Hong Kong

Status

Completed

Conditions

Colitis, Ulcerative

Treatments

Device: C2

Procedure: colonoscopy

Study type

Interventional

Funder types

Other

Identifiers

NCT02469103

UC-C2

Details and patient eligibility

About

The purpose of this study is to investigate the accuracy of second generation colon capsule (C2) in evaluating colonic mucosal inflammation of ulcerative colitis patients, using conventional endoscopy as the gold standard.

Full description

Consecutive patients with ulcerative colitis will be recruited. Second generation colon capsule endoscopy (C2) and conventional colonoscopy will be performed one after another on the same day. Colonic mucosal inflammation will be scaled by physicians who review C2 videos and those who perform conventional colonosocpies independently. Physicians who review C2 videos and colonoscopists will be blinded to the findings of colonoscopies and C2 videos, respectively.The accuracy of C2 in evaluating mucosal inflammation will be evaluated, using conventional endoscopy as the gold standard.

Enrollment

150 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

age 18-80 years
suspected or known UC
written informed consent

Exclusion criteria

patients with severe UC according to Truelove and Witts' criteria
current pregnancy/lactating
patients with a pacemaker or other implanted electromedical device
the presence of dysphagia
patients at higher risk of capsule retention (including Crohn's disease, small bowel tumor, radiation enteropathy, previous intestinal surgery, acute abdominal pain without regular defecation)
patients with a contraindication to bowel preparation (congestive heart failure, renal insufficiency, a life-threatening condition)
patients with an allergy to polyethylene glycol, sodium phosphate solution, metoclopramide or bisacodyl suppository