NIPH Clinical Trials Search

Randomized Controlled Trial to assess the efficacy of a shielding method that utilises polyglycolic acid(PGA) sheets and fibrin glue to prevent bleeding after endoscopic submucosal dissection (ESD) for gastric neoplasms

Basic Information

Recruitment status	Complete: follow-up complete
Health condition(s) or Problem(s) studied	early gastric cancer/gastric adenoma
Date of first enrollment	2014/09/15
Target sample size	140
Countries of recruitment	Japan
Study type	Interventional
Intervention(s)	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 gastric ESD.

Outcome(s)

Primary Outcome

post-ESD bleeding rate(from soon after ESD to 28 days after ESD)

Secondary Outcome

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

Key inclusion & exclusion criteria

Age minimum	20years-old
Age maximum	Not applicable
Gender	Male and Female
Include 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.
Exclude 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.