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This study evaluated the efficacy of fibrin glue for preventing post-endoscopic submucosal dissection (ESD) bleeding in high-risk patients for bleeding (expected iatrogenic ulcer size ≥ 40 mm or receiving antithrombotic therapy).A multicenter, open-label, randomized controlled trial was performed at four tertiary-medical centers in Korea between July 1, 2020, and June 22, 2022. Patients with gastric neoplasm and a high risk of post-ESD bleeding were enrolled and allocated at 1:1 to a control group (standard ESD) or a fibrin glue group (fibrin glue applied to iatrogenic ulcers after standard ESD). The primary outcome was overall bleeding events within 4 weeks. The secondary outcomes were acute bleeding (within 48 hours post-ESD) and delayed bleeding (48 hours to 4 weeks post-ESD).In total, 254 patients were randomized and 247 patients were included in the modified intention-to-treat population (125 patients in the fibrin glue group, 122 patients in the control group). Overall bleeding events occurred in 12.0% (15/125) of the fibrin glue group and 13.1% (16/122) of the control group (p=0.791). Acute bleeding events were significantly less common in the fibrin glue group than in the control group (1/125 vs. 7/122, p=0.034). Delayed bleeding events occurred in 11.2% (14/125) of the fibrin glue group and 7.3% (9/122) in the control group (p=0.301).This trial failed to show a preventive effect of fibrin glue on overall post-ESD bleeding in high-risk patients. However, the secondary outcomes suggest a potential sealing effect of fibrin glue during the acute period.

INTRODUCTION: Endoscopic submucosal dissection (ESD) is a preferred treatment option for superficial esophageal squamous cell carcinoma (SESCC). However, only few studies compared long-term survival outcomes of ESD with surgery. This study compared the overall survival (OS), recurrence-free survival, and complication rates of ESD with those of surgery. METHODS: We reviewed patients who underwent ESD (n = 70) or surgery (n = 114) for SESCC at Seoul National University Hospital from 2011 to 2017. A propensity score-matched analysis was used to reduce selection bias. To increase the precision of our results interpretation, subgroups were analyzed according to the depth of tumor invasion. RESULTS: In the matching study, the ESD group (n = 34) showed comparable survival outcomes with the surgery group (n = 34). The 5-year OS rates were 89.4% vs 87.8% for the ESD and the surgery groups, respectively; similarly, the 5-year recurrence-free survival rates were 90.9% and 91.6%, respectively. The ESD group showed a lower early major complication rate (2.9% [1 of 34] vs 23.5% [8 of 34], P < 0.001) and shorter hospital stay (median, 3.0 days vs 16.5 days, P < 0.001) than the surgery group. In the tumor in situ (Tis)-subgroup, ESD showed better OS than esophagectomy (P = 0.030). Between-group comparisons of survival outcomes in the T1a and T1b subgroups revealed no significant differences. DISCUSSION: Long-term outcomes of ESD are comparable with surgery for patients with SESCC. For early major complications and duration of hospital stay, ESD was associated with better outcomes than radical surgery. These results support ESD as the preferred treatment option for SESCC.