The efficacy of PGA shielding in gastric ESD for the patients taking anticoagulants or DAPT

Phase 2

Recruiting

• Conditions: early gastric cancer of gastric adenoma; early gastric cancer, gastric adenoma, post-ESD bleeding; C06.405.249.767

• Registration Number: JPRN-jRCTs031200077
• Lead Sponsor: Tsuji Yosuke

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-08-03
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

Those who meet all the below-mentioned criteria and provide written informed consent.
1) Regularly taking either of the following antithrombotic drugs within 28 days before gastirc ESD:
1. aspirin + thyenopyridine (ticlopidine, clopidogrel, prasugrel)
2. anticoagulants (warfarin, edoxaban, dabigatran, rivaroxaban, apixaban)
2) Single ulcer formed after ESD (including ESD for adjacent multiple lesions)
3) Endoscopic biopsy within 90 days of the ESD date revealing the target lesion for ESD is pathologically adenoma or cancer. The pathological specimen or report in the referring hospital is enough. And endoscopic examination within 60 days of the ESD date performed in each participating institution revealing that the target lesion is indicated for ESD.
4) Enhanced CT scan of chest to abdomen within 60 days of ESD reveals no lymph node or distant metastasis. Plain CT is permitted if patients have renal dysfunction, allergy to contrast agents, or asthma.
5) 20 years old or older of either sex
6) 0-2 in PS (ECOG)
7) All the following conditions are met in the last blood laboratory test within 28 days of ESD (no blood transfusion within 14 days of blood sampling):
1.hemoglobin : 9 g/dL or more
2.platelet :100,000 /mm3 or more
3.AST/ALT : 100 IU/L or less
4.creatinine : 2.0 mg/dL or less
8) possible to follow the clinical course for 28 days after ESD
9)Obtaining written informed consent

Exclusion Criteria

Those who correspond to any of th following criteria.
1) Undergoing endoscopic treatment for uuper GI lesions within 28 days before enrolling in the study.
2) Planning to perform simultaneous endoscopic treatment for esohapgeal or duodenal lesions.
3) Planning to perform endoscopic treatment for upper GI within 28 days after gastric ESD.
4) The history of allergy to PPI.
5) Female planning to get pregnant/in pregnancy/breast-feeding
6) The history of myocardial infarction or unstable angina within 3 months of enrolling in the study.
7) concomitant uncontrollable hypertension
8) having concomittant cancer in other organs
9) The cases physicians-in-charge consider to be inappropriate for participating in the study for other reasons than the above-mentiond ones

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
post-ESD bleeding rate (from just after ESD to 28 days later)

Secondary Outcome Measures

Name	Time	Method
1) the late phase post-ESD bleeding rate (from 7days after ESD to 28 days later)<br>2) each post-ESD bleeding rate in a DAPT or anticoagulants group<br>3) the rate of blood transfuson assosiated with post-ESD bleeding<br>4) the rate of adverse events caused by PGA sheets or fibrin glue<br>5) risk factors for post-ESD bleeding<br>6) post-ESD bleeding rate in the cases where PGA shielding is technically successful <br>7) the rate of urgent endoscopy<br>8) the rate of thromboenbolism<br>9) the time for applying PGA sheets