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

JRCT ID: jRCTs072180006

Registered date:12/11/2018

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: lower gastrointestinal endoscopy examinee
• Date of first enrollment: 03/12/2018
• Target sample size: 600
• Study type: Interventional

Intervention(s)

Subjects are randomized to the following two groups.
group A: inspect at the first pass by LCI and the second pass by WLI
group B: inspect at the first pass by WLI and the second pass by LCI

Outcome(s)

• Primary Outcome: miss rate
• Secondary Outcome: adenoma detection rate, number of adenomas detected at the first pass, miss subject rate, number of adenomas newly detected at second pass, proportion of total number of missed adenomas to total number of adenomas

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 79age old
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Shimoda Ryo
• Source(s) of Monetary Support: Fujifilm Corporation