A prospective randomized controlled trial of autofluorescence imaging colonoscopy with transparent hood versus conventional colonoscopy for adenoma detection.

UMIN ID: UMIN000001473

Registered date:01/11/2008

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Colorectal neoplasm
• Date of first enrollment: 2008/11/01
• Target sample size: 550
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

White light imaging without hood group
White light imaging with hood group
Autofluorescence imaging without hood group
Autofluorescence imaging with hood group

Outcome(s)

• Primary Outcome: Neoplasm detection rate
• Secondary Outcome: Total number of cancers in both group. Total number of depressed/flat/sessile lesions. Total number of hyperplastic polyp. Total number of adenomas less than 5mm. Right-sided versus left-sided location. Total number of adenomas larger than 1cm. Total number of patients with polyps. Total number of patient with adenoma less than 5mm. Procedure time (intubation time and observation time). Adverse event.

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1)Patients who had previously undergone major surgery. 2)Patients with open bleeding or symptoms suspected colonic stenosis. 3)Patients with inflammatory bowel disease, familial polyposis and known colon neoplasm. 4)Patients who are receiving anticoaglant medication or bleeding tendency. 5)Patients with severe organ failure. 6)Patients without informed consent. 7)Patients who are regarded in-eligible by the doctor who participates in this study.

Related Information

• Primary Sponsor: Osaka Medical Center for Cancer and Cardiovascular Diseases
• Source(s) of Monetary Support: None