NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCT1042230023

Registered date:24/05/2023

TWICE trial

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedcolorectal adenomas, colorectal cancer
Date of first enrollment10/10/2023
Target sample size1414
Countries of recruitment
Study typeInterventional
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 OutcomeAdenoma detection rate in the right colon
Secondary OutcomeAdenoma 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
GenderBoth
Include criteriaAsymptomatic 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

Contact

Public contact
Name Hidenori Kimura
Address Seta-Tsukinowa-cho,Otsu City,Shiga Shiga Japan 520-2192
Telephone +81-77-548-2217
E-mail kimura64@belle.shiga-med.ac.jp
Affiliation Shiga University of Medical Science Hospital
Scientific contact
Name Kenichiro Imai
Address 1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka Shizuoka Japan 411-8777
Telephone +81-55-989-5222
E-mail ke.imai@scchr.jp
Affiliation Shizuoka Cancer Center