BACKGROUND: The prevention of bleeding after endoscopic submucosal dissection (ESD) for gastric neoplasms is still an important problem. OBJECTIVE: To investigate the efficacy and safety of a shielding method that uses polyglycolic acid (PGA) sheets and fibrin glue to prevent post-ESD bleeding in high-risk patients. DESIGN: A nonrandomized trial with historical control subjects. SETTING: A single academic hospital in Japan. PATIENTS: From July 2013 to February 2014, 45 ESD-induced ulcers in 41 patients with a high risk of bleeding were enrolled in a study group. Forty-one consecutive ESD-induced ulcers in 37 control subjects with a high risk of bleeding were treated in 2013 before the first enrollment. INTERVENTIONS: We placed PGA sheets on the mucosal defect and fixed with fibrin glue in the study group. MAIN OUTCOME MEASUREMENTS: The post-ESD bleeding rate. RESULTS: The post-ESD bleeding occurred at a rate of 6.7% in the study group (3/45 lesions) and 22.0% in the historical control group (9/41 lesions). There was a significant difference in the post-ESD bleeding rate between the 2 groups (P = .041). LIMITATIONS: A nonrandomized trial with historical control subjects; a single-center analysis; small sample size. CONCLUSIONS: The endoscopic tissue shielding method with PGA sheets and fibrin glue appears to be promising for the prevention of post-ESD bleeding. ( CLINICAL TRIAL REGISTRATION NUMBER: UMIN000011058.).
BACKGROUND: The prevention of bleeding after endoscopic submucosal dissection (ESD) for gastric neoplasms is still an important problem. OBJECTIVE: To investigate the efficacy and safety of a shielding method that uses polyglycolic acid (PGA) sheets and fibrin glue to prevent post-ESD bleeding in high-risk patients. DESIGN: A nonrandomized trial with historical control subjects. SETTING: A single academic hospital in Japan. PATIENTS: From July 2013 to February 2014, 45 ESD-induced ulcers in 41 patients with a high risk of bleeding were enrolled in a study group. Forty-one consecutive ESD-induced ulcers in 37 control subjects with a high risk of bleeding were treated in 2013 before the first enrollment. INTERVENTIONS: We placed PGA sheets on the mucosal defect and fixed with fibrin glue in the study group. MAIN OUTCOME MEASUREMENTS: The post-ESD bleeding rate. RESULTS: The post-ESD bleeding occurred at a rate of 6.7% in the study group (3/45 lesions) and 22.0% in the historical control group (9/41 lesions). There was a significant difference in the post-ESD bleeding rate between the 2 groups (P = .041). LIMITATIONS: A nonrandomized trial with historical control subjects; a single-center analysis; small sample size. CONCLUSIONS: The endoscopic tissue shielding method with PGA sheets and fibrin glue appears to be promising for the prevention of post-ESD bleeding. ( CLINICAL TRIAL REGISTRATION NUMBER: UMIN000011058.).