Brief Article
Copyright ©2013 Baishideng Publishing Group Co., Limited. All rights reserved.
World J Gastroenterol. May 28, 2013; 19(20): 3069-3076
Published online May 28, 2013. doi: 10.3748/wjg.v19.i20.3069
Efficacy and safety of 0.4 percent sodium hyaluronate for endoscopic submucosal dissection of gastric neoplasms
Young Dae Kim, Jun Lee, Ju Yeon Cho, Seok Won Kim, Seong Hwan Kim, Young Kwan Cho, Jin Seok Jang, Ji Sun Han, Joo Young Cho
Young Dae Kim, Jun Lee, Ju Yeon Cho, Seok Won Kim, Division of Gastroenterology and Hepatology, Department of Internal Medicine, Medical School, Chosun University, Gwangju 501-717, South Korea
Seong Hwan Kim, Young Kwan Cho, Department of Internal Medicine, Eulji Hospital, Eulji University, Seoul 139-872, South Korea
Jin Seok Jang, Ji Sun Han, Department of Internal Medicine, Dong A University College of Medicine, Busan 602-715, South Korea
Joo Young Cho, Department of Internal Medicine, Institute for Digestive Research, Digestive Disease Center, Soonchunhyang University College of Medicine, Seoul 140-743, South Korea
Author contributions: Kim YD, Kim SH, Jang JS and Cho JY supervised and performed the experiments; Lee J, Cho JY, Kim SW, Cho YK and Han JS performed the majority of the experiments; Kim YD drafted and wrote the manuscript.
Supported by BMI Korea, Co., Ltd
Correspondence to: Joo Young Cho, MD, PhD, Department of Internal Medicine, Institute for Digestive Research, Digestive Disease Center, Soonchunhyang University College of Medicine, 22, Daesagwn-gil, Yongsangu, Seoul 140-743, South Korea. cjy6695@dreamwiz.com
Telephone: +82-2-7099202 Fax: +82-2-7099202
Received: December 29, 2012
Revised: March 19, 2013
Accepted: April 13, 2013
Published online: May 28, 2013
Processing time: 149 Days and 19.1 Hours
Abstract

AIM: To evaluate the efficacy and safety of sodium hyaluronate solution (SH) in endoscopic submucosal dissection (ESD) of gastric neoplasms.

METHODS: 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.

RESULTS: 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.

CONCLUSION: 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.

Keywords: Sodium hyaluronate; Endoscopic submucosal dissection; Gastric neoplasm; Endoscopic mucosal resection

Core tip: Saline-assisted endoscopic mucosal resection is an established method for excision of nonpolypoid early neoplastic lesions of the gastrointestinal tract. However, it is sometimes difficult to maintain a desired level of tissue elevation after injection of saline, especially when using a one-channeled endoscope. Adequate elevation of the mucosa and sufficient elevation time is achieved more effectively when a material more viscous than normal saline (NS) is used. The 0.4% sodium hyaluronate solution (SH) used in this study provides a more effective and prolonged cushion effect for large lesions without serious adverse events compared to NS. Therefore, endoscopic submucosal dissection (ESD) with SH is more useful than ESD with NS.