Clinical efficacy of EMR with submucosal injection of a fibrinogen mixture: a prospective randomized trial

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. Submucosal injection is essential to performing EMR easily, and various solutions have been proposed to create a long-lasting submucosal fluid cushion. To assess the efficacy of a fibrinogen mixture (FM) as a submucosal injection solution. A prospective, randomized, controlled trial. At a tertiary care, academic medical center. 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. We performed EMR only with a conventional method. En bloc resection rate, complete resection rate, complications, and other procedure-related outcomes. 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). 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. The FM is a reliable submucosal injection solution for conventional EMR.