TWICE trial

JRCT ID: jRCT1042230023

Registered date:24/05/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: colorectal adenomas, colorectal cancer
• Date of first enrollment: 10/10/2023
• Target sample size: 1414
• Study type: Interventional

Intervention(s)

Additional forward view examination in the right colon with narrow-band imaging
(Control group)
Standard withdrawal colonoscopy group;
Standard forward view examination in the whole colon with white-light imaging
(Test group)
Second forward view with narrow-band imaging group;
Second forward view examination of the right colon with narrow-band imaging after the first right-colon examination with white-light imaging

Outcome(s)

• Primary Outcome: Adenoma detection rate in the right colon

Secondary Outcome

Adenoma detection rate of the whole colon
Additional adenoma detection rate at the second observation
Total number of adenomas detected in each group
Adverse events
Predictors for adenoma detection rate in the right colon
Recommended surveillance interval according to guidelines
Performance evaluation of colonoscopy in narrow-band imaging observation
Serrated polyp detection rate in the right colon
Polyp (adenoma or serrated polyp) detection rate in the right colon
Total number of adenomas and serrated polyps detected in each group

Key inclusion & exclusion criteria

• Age minimum: >= 50age old
• Age maximum: <= 75age old
• Gender: Both
• Include criteria: Asymptomatic patients undergoing colonoscopy for colorectal cancer screening or polyp surveilance

Exclude criteria

(1)Prior colonic resection
(2)Inflammatory bowel disease, polyposis syndrome
(3)Irreversible coagulopathy and thrombocytopenia
(4)Pregnant woman
(5)Infeasibility of suspending antithrombotic drugs

Related Information

• Primary Sponsor: Imai Kenichiro