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Clinical Trials/JPRN-UMIN000025754
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

Sponsor
Division of Endoscopy, Shizuoka Cancer Center

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