Verification for the efficacy of third look endoscopy to prevent delayed postoperative bleeding after gastric endoscopic submucosal dissection in patients with antithrombotic drugs -a prospective study

Phase 2

• Conditions: early gastric cancer / adenoma

• Registration Number: JPRN-UMIN000025607
• Lead Sponsor: Yokohama City University Medical Center

Brief Summary

In total, 96 patients and 114 specimens were finally evaluated. The overall PDB rate was 7.9% (9/114) [90%CI: 4.7-13.1, P = 0.005], while the late-and early-onset PDB rates (L-PDB and E-PDB) were 5.3% [90%CI: 2.7-9.9, P < 0.0001] and 2.6% [90%CI: 1.1-6.4, P = 0.51], respectively.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-01-16
• Study Completion: 2020-03-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

(1) Patient with severe infection (2) Patient who are pregnant, may be pregnant, or prefer pregnancy during treatment (3)for Mental disease, dementia,it is difficult to participate study (4) Patient with unstable angina, or myocardial infarction within 6 months. (5)Patient with respiratory diseases requiring continuous oxygen therapy (6)Patient with uncontrollable hypertension (7)Patient with uncontrollable Diabetes (8)anemia requiring transfusion(Hb<7.0g/dl), Easy to bleed for low platelet (Plt<50000) (9) Patient judged inappropriate

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall delayed bleeding rate

Secondary Outcome Measures

Name	Time	Method
the early phase delayed bleeding rate the late phase delayed bleeding rate the delayed bleeding rate compared with the historical control group using propensity score matching.