The confirmatory clinical trial for investigating the preventive effect of shielding with polyglycolic acid sheets and fibrin glue on bleeding after gastric endoscopic submucosal dissection for the patients taking anticoagulants or dual antiplatelet drugs

Tsuji Yosuke0 个研究点目标入组 130 人开始时间: 2020年8月3日最近更新: 2023年10月17日

试验速览

暂无简介。

•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

•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

发起方

Tsuji Yosuke