A Randomized Controlled Trial of Fibrin Glue to Prevent Bleeding After Gastric Endoscopic Submucosal Dissection.

INTRODUCTION: This study evaluated the efficacy of fibrin glue for preventing postendoscopic submucosal dissection (ESD) bleeding in high-risk patients for bleeding (expected iatrogenic ulcer size ≥40 mm or receiving antithrombotic therapy). METHODS: A multicenter, open-label, randomized controlled trial was performed at 4 tertiary medical centers in South 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). RESULTS: 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 and 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) in the fibrin glue group and 7.3% (9/122) in the control group ( P = 0.301). DISCUSSION: 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.

Endoscopic Submucosal Dissection Versus Surgery for Superficial Esophageal Squamous Cell Carcinoma: A Propensity Score-Matched Survival Analysis.

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.

Exploring the possibility of endoscopic submucosal dissection for clinical submucosal invasive early gastric cancers.

BACKGROUND: The current standard treatment modality for clinical submucosal invasive (cT1b) early gastric cancer (EGC) is surgery. However, there are discrepancies in T staging between pre- and post-operative findings, and in cases of overestimation, patients may lose the opportunity to preserve the stomach. The aim of this study was to analyze surgical outcomes of cT1b EGC and determine the pre-treatment factors favoring ESD. METHODS: Patients who underwent gastrectomy for cT1b EGC with a tumor size of 30 mm or less in diameter and differentiated-type histology were retrospectively reviewed from January 2010 to December 2014. According to the final surgical pathologic results, two groups were classified: patients whose pathologic results qualified for current ESD indication (ESD-qualified group, n = 203) and patients whose pathologic results made them ineligible for ESD (ESD-disqualified group, n = 261). The preoperative clinical characteristics were compared. RESULTS: Forty-three percent of the patients (203/464) who underwent gastrectomy for cT1b EGC qualified for ESD; their endoscopic lesion tended to be smaller than 20 mm in size and located in the distal part of stomach. In addition, the ESD-qualified group showed a significantly higher proportion of well-differentiated tubular adenocarcinoma on endoscopic biopsy and of the flat/depressed type in the endoscopic evaluation. CONCLUSION: Forty-three percent of the patients with cT1b EGC who underwent gastrectomy had a chance to preserve their stomach by ESD. Therefore, pre-treatment factors such as endoscopic lesion size, location, histology, and gross type should be considered for treatment modality selection for cT1b EGC.