Efficacy and safety of 0.4 percent sodium hyaluronate for endoscopic submucosal dissection of gastric neoplasms

Abstract

To evaluate the efficacy and safety of sodium hyaluronate solution (SH) in endoscopic submucosal dissection (ESD) of gastric neoplasms. A prospective multicenter randomized, double blind, controlled trial was designed and utilized in this study. A total of 76 patients with 5-20 mm sized gastric neoplasms were enrolled at three academic hospitals in South Korea from June 2011 to October 2011. Patients were randomly assigned to the 0.4% sodium hyaluronate or control groups. All lesions underwent endoscopic ESD. ESD was performed with 0.4%SH and normal saline (NS) solution for submucosal injection. Efficacy was assessed using en bloc resection and the number of additional injections. Secondary evaluation variables were the volume of injection material, steepness of mucosal elevation, bleeding rate, procedural time and operator satisfaction. Finally, the safety was assessed by analyzing adverse events during the study. The usefulness rate in the 0.4%SH group and the controlled group had statistically significant difference under intention to treat (ITT) analysis (90.91% vs 61.11% P = 0.0041). Under per protocol (PP), the usefulness rate is statistically significant different (93.10% vs 61.76%, P = 0.0036). The difference in volume of the solution injected between 0.4%SH group and the controlled group and NS group was also statistically significant under intention to treat and per protocol analysis (ITT: 0.03 ± 0.02 mL vs 0.06 ± 0.03 mL, P = 0.0003, PP: 0.03 ± 0.02 mL vs 0.06 ± 0.03 mL, P = 0.0004). Satisfaction above the grade good was significantly higher in the SH group under intention to treat and per protocol analysis (ITT: 90.91% vs 61.11%, P = 0.0041, PP = 93.11% vs 61.77%, P = 0.0022). Adverse events above grade 3 were not noticed in either group. All adverse events were treated and were judged as not associated with the submucosal injection solutions. 0.4%SH solution is a safe and effective agent that doesn't cause any significant adverse events and is useful for submucosal injection during ESD.