early gastric cancer/gastric adenoma
Conditions
Interventions
endoscopic tissue shielding method with PGA sheets and fibrin glue will be performed after gastric ESD.
endoscopic tissue shielding method with PGA sheets and fibrin glue will not be performed after g
Sponsors
Graduate School of Medicine, University of Tokyo
NTT Medical Center Tokyo, Takeda General Hospital, Sanraku Hospital, Tokatsu-Tsujinaka Hospital, Yokohama City University Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Meet at least one of the following criteria of high risk bleeding after ESD. a)resection size would exceed 40mm because tumor size is expected to be >= 20mm. b)resection size would exceed 40mm because ulcer scar is inside the tumor. c)resection size would exceed 40mm because multiple adjacent lesions have to be resected in an en block fashion. d)taking oral antithrombotic drug. 2)Post-ESD ulcer scar is expected to be one lesion (irrespective of the number of tumors). 3)Preoperative pathological diagnosis of gastric cancer or adenoma is confirmed by endoscopic biopsy. 4)no evidence of metastasis on computed tomography. 5)Aged 20 years old or over. 6)PS (ECOG) of 0 to 2. 7)Meet all of the following criteria (without blood transfusion in the past 14 days). a) Hb >=9g/dl b) Plt >=100,000/mm3 c) AST,ALT <=100IU/l d) Cre <=2.0mg/dl 8)Available to be observed for at least 28 days after ESD. 9)With written informed consent.
Exclusion criteria
Exclusion criteria: 1)History of endoscopic treatment for upper GI lesion in the past 28 days. 2)With a scheduled endoscopic treatment for esophageal lesion or duodenal lesion concurrently. 3)With a scheduled endoscopic treatment for upper GI lesion in 28 days after gastric ESD. 4)with heparinization. 5)With an allergy to proton pomp inhibitor. 6)Pregnant or lactation woman. 7) History of myocardial infarction or unstable angina pectoris within 3 months. 8)With uncontrollable hypertension. 9)Patients whom investigators judge to be unsuitable for this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| post-ESD bleeding rate(from soon after ESD to 28 days after ESD) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)late post-ESD bleeding rate(from meal commencement after ESD to 28 days after ESD) 2)blood transfusion rate associated with post-ESD bleeding 3)the rate of complications caused by PGA sheets or fibrin glue 4)risk factor for post-ESD bleeding 5)post-ESD bleeding rate in the patients whose resected specimen sizes are over 40mm 6)post-ESD bleeding rate in the cases where mucosal defects are shielding completely by PGA sheets 7)the rate of emergency endoscopy after ESD | — |
Countries
Japan
Contacts
Public ContactYosuke Kataoka
Graduate School of Medicine, University of Tokyo Department of gastroenterology Laboratory No.108
Outcome results
None listed