JPRN-UMIN000025754CompletedPhase 2
Safety and efficacy of Tip-in endoscopic mucosal resection for large flat colorectal Adenomas: a Randomized control trial - STAR trial
Division of Endoscopy, Shizuoka Cancer Center0 sites85 target enrollmentStarted: February 14, 2017Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 85
Study Overview
Brief Summary
We analyzed 41 lesions in the Tipin EMR group and 41 lesions in the EMR group. En bloc resection was achieved in 37 (90.2 percent) patients in the Tipin EMR group and 30 (73.1 percent) in the EMR group. The adjusted odds ratio of en bloc resection in Tip-in EMR vs. EMR was 3.46 (95 percent CI 1.06 to 13.6) with a significant difference (P 0.040). There were no differences between Tipin EMR and EMR in adverse events (0 vs 4.8 percent) and median procedure time (7 vs 5 min).
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 20years-old to ot applicable (—)
- Sex
- All
Inclusion Criteria
- Not provided
Exclusion Criteria
- •1. Cases with clinical diagnosis of T1 cancer 2. Cases with difficulties to interrupt intake of anticoagulant drugs 3. Inappropriate cases by investigators
Investigators
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