1.
Efficacy and safety of novel hemostatic gel in endoscopic sphincterotomy or endoscopic papillectomy: A multicenter, randomized controlled clinical trial
Choi JH, Cho IR, Lee SH, Kim JS, Park N, Lee MW, Jang DK, Paik WH, Ahn DW, Ryu JK, et al
Digestive and liver disease : official journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver. 2023
Abstract
BACKGROUND Endoscopists often experience obstacles with traditional hemostasis using the side-viewing duodenoscope for bleeding after endoscopic sphincterotomy (EST) or endoscopic papillectomy (EP). AIMS In this randomized controlled trial, we evaluated the efficacy and safety of a novel hemostatic gel for post-EST or post-EP bleeding. METHODS A randomized trial was conducted from November 2020 to December 2021 at two tertiary centers in South Korea. Patients who experienced bleeding immediately after EST or EP were enrolled in the study, and primary hemostasis was achieved with either the novel hemostatic gel or epinephrine spray. RESULTS A total of 84 patients were enrolled in this study, and 41 patients were finally analyzed in each group. Hemostatic gel was significantly superior to epinephrine spray for successful primary hemostasis (100% vs. 85.4%; P = 0.026). ). In terms of delayed bleeding, no significant difference was observed between the hemostatic gel and epinephrine spray (2.4% vs. 7.3%; P = 0.329). The mean procedural time was significantly higher for the hemostatic gel than epinephrine spray (3.23 ± 1.94 vs. 1.76 ± 0.99 min; P < 0.001), and no differences were observed in the adverse events. CONCLUSIONS The novel hemostatic gel is expected to achieve satisfactory results with easier hemostasis for immediate bleeding after EST or EP. (Registered in Clinical Research Information Service: KCT0005607).
2.
Clinical efficacy of EMR with submucosal injection of a fibrinogen mixture: a prospective randomized trial
Lee SH, Park JH, Park do H, Chung IK, Kim HS, Park SH, Kim SJ, Cho HD
Gastrointestinal Endoscopy. 2006;64((5):):691-6.
Abstract
BACKGROUND Submucosal injection is essential to performing EMR easily, and various solutions have been proposed to create a long-lasting submucosal fluid cushion. OBJECTIVE To assess the efficacy of a fibrinogen mixture (FM) as a submucosal injection solution. DESIGN A prospective, randomized, controlled trial. SETTING At a tertiary care, academic medical center. PATIENTS A total of 72 patients with early gastric neoplasm were randomly assigned to receive EMR with submucosal injection of normal saline solution (NS) or an FM. INTERVENTION We performed EMR only with a conventional method. MAIN OUTCOME MEASUREMENTS En bloc resection rate, complete resection rate, complications, and other procedure-related outcomes. RESULTS No significant differences were observed between the 2 groups (the FM group vs the NS group) in the rates of en bloc resection (80. 6% vs 88. 9%), complete resection rate (86. 1% vs 80. 6%), and recurrence rate (3% vs 6. 1%). Mean procedure time was significantly shorter in the FM group vs the NS group (11. 39 +/- 3. 07 minutes vs 13. 93 +/- 3. 26 minutes; P < . 05). Mean submucosal injection volume of the FM group was significantly less than that of the NS group (9. 81 +/- 2. 26 mL vs 14. 32 +/- 2. 35 mL; P < . 05). Also, additional submucosal injection to maintain elevation of the lesion was less frequently required in the FM group than in the NS group (5. 6% vs 33. 3%; P < . 05). LIMITATIONS The main limitations were the method of EMR (only included the conventional method) and the size of lesions (<30 mm), because a long-lasting submucosal fluid cushion was more important in the dissection method and larger tumors. CONCLUSIONS The FM is a reliable submucosal injection solution for conventional EMR.