Comparative study on the detectability of colonic adenomas in LCI and WLI in lower gastrointestinal endoscopy

Phase 3

• Conditions: lower gastrointestinal endoscopy examinee

• Registration Number: JPRN-jRCTs072180006
• Lead Sponsor: Shimoda Ryo

Brief Summary

A multicenter, randomized, back-to-back design study was conducted to compare LCI and WLI on the detection of colonic adenomas. The primary endpoint was the miss rate. The full analysis set was 327 and 320 in LCI-WLI group and WLI-LCI group, respectively. The mean miss rates were 9.3% and 20.6% in LCI-WLI group and WLI-LCI group, respectively, and it was statistically significant (Wilcoxon test, P<0.001). It was concluded that LCI was superior to WLI on detection of colonic adenomas.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-11-12
• Study Completion: 2020-03-10
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 678

Inclusion Criteria

1) Lower GI endoscopy examinee who are between 18 and 79 years (at the time signing informed consent)
2) Patients who understand the contents of informed consent form and who can voluntarily sign informed consent form (in the case of a minor, also informed consent from proxies)
3) Patients who does not receive lower digestive tract endoscopy in the institute concerned for the past three years
4) Patients requiring lower digestive tract endoscopy (meeting any of the following criteria)
(a)Positive fecal occult blood
(b)Subjects with diagnosis or treatment history of large intestine adenoma, colorectal cancer (it is ineligible if colon/rectum resection was undertaken)
(c)Subjects with digestive symptoms such as abdominal pain, diarrhea and constipation
(d)Subjects who requires the screening of gastrointestinal cancer
(e)Subjects with a family affection history of colorectal cancer and large intestine adenoma
(f)Any other subjects who are regarded that the investigator needed lower digestive tract endoscopy

Exclusion Criteria

1)Patients who have undergone intestinal resection
2)Patients with a history of inflammatory bowel disease
3)Patients with a history of familial adenomatous polyposis
4)Patients with a history of hereditary nonpolyposis colorectal cancer
5)Patients with severe intestinal adhesions known beforehand
6)Patients who the investigator determined difficult to participate in the study

Study & Design

• Study Type: Interventional
• Study Design: Not specified