TRANSIT study

JRCT ID: jRCT1042210155

Registered date:04/03/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Obstructive colorectal cancer
• Date of first enrollment: 16/03/2022
• Target sample size: 215
• Study type: Interventional
• Intervention(s): Colonoscopy for obstructive colorectal cancer after insertion of seif-expandable metal stent

Outcome(s)

• Primary Outcome: Detection rate of synchronous colorectal cancer in the proximal side

Secondary Outcome

(1) Cecal intubation rate
(2) Percentage and number of colorectal neoplastic lesions detected by colonoscopy
(3) Comparison with colorectal lesions detected by other imaging tests
(4) The number needed to scope in advanced neoplasia
(5) Adverse events
(6) Change rate of operative method
(7) Synchronous colorectal cancer detected by postoperative surveillance colonoscopy

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Obstructive colorectal cancer except cecum and ascending colon
2) After insertion of self-expandable metal stent
3) 20 years and older
4) Written informed consent is obtained

Exclude criteria

1) Performance Status 3 or higher
2) Colorectal Obstructive Scoring System 0-1
3) Difficulty in taking oral bowel preparation
4) Fever of 38.0 or higher or abdominal pain
5) No immediate surgery planned
6) Inappropriate cases by investigators

Related Information

• Primary Sponsor: Hotta Kinichi