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.