Unique ID issued by UMIN | UMIN000020174 |
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Receipt number | R000023306 |
Scientific Title | Prospective multicenter trial for efficacy of potassium competitive acid blocker to reduce delayed bleeding after gastric endoscopic submucosal dissection in patients on antithrombotic therapy |
Date of disclosure of the study information | 2015/12/11 |
Last modified on | 2018/12/13 23:24:26 |
Prospective multicenter trial for efficacy of potassium competitive acid blocker to reduce delayed bleeding after gastric endoscopic submucosal dissection in patients on antithrombotic therapy
Preventive effect of P-CAB for postoperative bleeding after gastric ESD
Prospective multicenter trial for efficacy of potassium competitive acid blocker to reduce delayed bleeding after gastric endoscopic submucosal dissection in patients on antithrombotic therapy
Preventive effect of P-CAB for postoperative bleeding after gastric ESD
Japan |
Gastric neoplasm
Gastroenterology |
Malignancy
NO
To reveal the preventive effect of P-CAB for postoperative bleeding in high-risk patients after gastric ESD
Safety,Efficacy
Post-ESD bleeding rate
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Prevention
Medicine |
Daily use of Vonoplazan (day 1 - 28)
20 | years-old | <= |
Not applicable |
Male and Female
1. Diagnosis of gastric adenoma or early gastric cancer satisfying the Japanese guideline criteria.
2. On antithrombotic therapy
3. 20 years or older
4. Performance status (ECOG) is 0, 1 or 2
5. With a written informed consent.
1. History of gastrectomy
2. Schedule of endoscopic treatment for esophageal or duodenal lesion concurrently.
3. History of endoscopic treatment for upper GI lesion in the past 28 days.
4. Schedule of endoscopic treatment for upper GI lesion within 28 days after the gastric ESD.
5. Systemic administration (intravenously or orally) of either one or more drugs of corticosteroid, anticoagulant agent.
6. Diagnosis of psychiatric diseases.
7. With active bacterial or fungus infection.
8. With uncontrollable hypertension.
9. Disqualified for the study by physicians.
50
1st name | |
Middle name | |
Last name | Tetsuo Takehara |
Osaka university graduate school of medicine
Gastroenterology and hepatology
Yamadaoka2-2, Suita, Osaka
06-6879-5111
takehara@gh.med.osaka-u.ac.jp
1st name | |
Middle name | |
Last name | Yoshito Hayashi |
Osaka university graduate school of medicine
Gastroenterology and hepatology
Yamadaoka2-2, Suita, Osaka
06-6879-5111
y.hayashi@gh.med.osaka-u.ac.jp
Osaka Gut Forum (OGF)
n/a
Self funding
NO
2015 | Year | 12 | Month | 11 | Day |
Unpublished
Completed
2015 | Year | 12 | Month | 09 | Day |
2015 | Year | 12 | Month | 24 | Day |
2015 | Year | 12 | Month | 11 | Day |
2018 | Year | 12 | Month | 13 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023306
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