Osamu Goto1, Tsuneo Oyama2, Hiroyuki Ono3, Akiko Takahashi2, Mitsuhiro Fujishiro4, Yukata Saito5, Seiichiro Abe5, Mitsuru Kaise1, Katsuhiko Iwakiri1, Naohisa Yahagi6. 1. Department of Gastroenterology, Nippon Medical School Graduate School of Medicine, Tokyo, Japan. 2. Division of Endoscopy, Saku Central Hospital Advanced Care Center, Saku, Japan. 3. Division of Endoscopy, Shizuoka Cancer Center, Shizuoka, Japan. 4. Department of Gastroenterology and Hepatology, Nagoya University Graduate School of Medicine, Nagoya, Japan. 5. Endoscopy Division, National Cancer Center Hospital, Tokyo, Japan. 6. Division of Research and Department for Minimally Invasive Treatment, Cancer Center, Keio University School of Medicine, Tokyo, Japan.
Abstract
BACKGROUND AND AIMS: Endoscopic hand-suturing (EHS) provides secure intraluminal mucosal closure and should decrease the risk of adverse events after gastric endoscopic submucosal dissection (ESD). We prospectively investigated the feasibility and safety of EHS after gastric ESD, particularly for preventing post-ESD bleeding. METHODS: Patients scheduled for gastric ESD at 3 institutions were prospectively recruited. Just after ESD, the mucosal defect was closed by EHS. The primary outcome was endoscopic assessment of adequately sustained closure of the defect on postoperative day 3. Endoscopy was performed to assess maintenance of the closure for the primary outcome. During postoperative weeks 3 to 4, patients were interviewed as outpatients about any occurrence of delayed bleeding. RESULTS: Data from 30 patients (15 each who did or did not take antithrombotic agents) were analyzed. Mucosal closure by EHS was completed in 29 of 30 cases (97%) and was well maintained on postoperative day 3 in 25 cases (84%). Emergency endoscopy was required for major postoperative bleeding in 3 cases (10%), including 1 in which suturing had been incomplete. Excluding 1 patient with a remnant stomach, the other 24 with sustained closure had no bleeding, regardless of whether they did or did not take antithrombotic agents (0/11 and 0/13, respectively). No serious adverse events occurred during EHS. CONCLUSIONS: Results show that EHS is feasible and safe with favorable outcomes. Provided that mucosal suturing is successfully completed and sustained, post-ESD bleeding can be decreased even in patients undergoing antithrombotic therapy. (Clinical trial registration number: UMIN 000033988.).
BACKGROUND AND AIMS: Endoscopic hand-suturing (EHS) provides secure intraluminal mucosal closure and should decrease the risk of adverse events after gastric endoscopic submucosal dissection (ESD). We prospectively investigated the feasibility and safety of EHS after gastric ESD, particularly for preventing post-ESD bleeding. METHODS:Patients scheduled for gastric ESD at 3 institutions were prospectively recruited. Just after ESD, the mucosal defect was closed by EHS. The primary outcome was endoscopic assessment of adequately sustained closure of the defect on postoperative day 3. Endoscopy was performed to assess maintenance of the closure for the primary outcome. During postoperative weeks 3 to 4, patients were interviewed as outpatients about any occurrence of delayed bleeding. RESULTS: Data from 30 patients (15 each who did or did not take antithrombotic agents) were analyzed. Mucosal closure by EHS was completed in 29 of 30 cases (97%) and was well maintained on postoperative day 3 in 25 cases (84%). Emergency endoscopy was required for major postoperative bleeding in 3 cases (10%), including 1 in which suturing had been incomplete. Excluding 1 patient with a remnant stomach, the other 24 with sustained closure had no bleeding, regardless of whether they did or did not take antithrombotic agents (0/11 and 0/13, respectively). No serious adverse events occurred during EHS. CONCLUSIONS: Results show that EHS is feasible and safe with favorable outcomes. Provided that mucosal suturing is successfully completed and sustained, post-ESD bleeding can be decreased even in patients undergoing antithrombotic therapy. (Clinical trial registration number: UMIN 000033988.).