1.
A Randomized, Controlled Trial of Fibrin Glue to Prevent Bleeding after Gastric Endoscopic Submucosal Dissection
Lee HD, Lee E, Kim SG, Shin CM, Park JC, Choi KD, HahnSoo-Jeong Cho S
The American journal of gastroenterology. 2022
Abstract
INTRODUCTION 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). METHODS 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). 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, 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). 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.
2.
Polysaccharide hemostatic powder to prevent bleeding after endoscopic submucosal dissection in high risk patients: a randomized controlled trial
Jung DH, Moon HS, Park CH, Park JC
Endoscopy. 2021;53(10):994-1002
Abstract
BACKGROUND : Bleeding after endoscopic submucosal dissection (ESD) is a severe adverse event. Several methods to prevent post-ESD bleeding (PEB) have been introduced; however, they have not been widely used because of technical difficulties. We aimed to investigate whether polysaccharide hemostatic powder (PHP), which is very easy to apply, can prevent early post-ESD bleeding, especially in patients with a high risk of post-ESD bleeding. METHODS : This was a prospective, multicenter, randomized, open-label, controlled trial. Patients with a high risk for post-ESD bleeding were enrolled. Patients with gastric neoplasms in whom the resected specimen size was expected to be > 40 mm and those who were regularly taking antithrombotic agents were defined as high risk patients. Patients were randomly assigned to the PHP or control groups. RESULTS Between May 2017 and September 2018, 143 patients were enrolled (PHP group, 73; control group, 70). The total post-ESD bleeding rate was 6.3 % (PHP group, 5.5 % vs. control group, 7.1 %; P = 0.74). There was no bleeding within 7 days after ESD in the PHP group. Continued antithrombotic use was an independent risk factor for post-ESD bleeding. In subgroup analysis excluding the patients who continued to take antithrombotic agents (n = 129) during ESD, the rate of post-ESD bleeding tended to be lower in the PHP group than in the control group (0 % vs. 6.3 %; P = 0.06). CONCLUSION : PHP did not demonstrate a significant effect on the prevention of post-ESD bleeding in this study. Further larger scale, randomized controlled trials are needed to confirm this.