Usefulness and safety of 0.4% sodium hyaluronate solution as a submucosal fluid "cushion" for endoscopic resection of colorectal mucosal neoplasms: A prospective multi-center open-label trial
- Equal contributors
1 Department of Internal Medicine, Sumitomo Besshi Hospital, Ehime, Japan
2 Endoscopy Division, National Cancer Center Hospital, Tokyo, Japan
3 Department of Internal medicine, Division of Gastroenterology, Jichi Medical University, Tochigi, Japan
4 Division of Digestive Endoscopy, National Cancer Center Hospital East, Chiba, Japan
5 Department of Gastroenterology, Toranomon Hospital, Tokyo, Japan
6 Department of Gastroenterology, Saku General Hospital, Nagano, Japan
7 Clinical Laboratory Division, National Cancer Center Hospital, Tokyo, Japan
8 Department of Internal Medicine, The Jikei University School of Medicine, Tokyo, Japan
9 Department of Gastroenterology, Maeda Hospital, Tokyo, Japan
10 Nihonbashi Daizo Clinic, Tokyo, Japan
BMC Gastroenterology 2009, 9:1 doi:10.1186/1471-230X-9-1Published: 8 January 2009
Sodium hyaluronate (SH) solution has been used for submucosal injection in endoscopic resection to create a long-lasting submucosal fluid "cushion". Recently, we proved the usefulness and safety of 0.4% SH solution in endoscopic resection for gastric mucosal tumors. To evaluate the usefulness of 0.4% SH as a submucosal injection solution for colorectal endoscopic resection, we conducted an open-label clinical trial on six referral hospitals in Japan.
A prospective multi-center open-label study was designed. A total of 41 patients with 5–20 mm neoplastic lesions localized in the colorectal mucosa at six referral hospitals in Japan in a single year period from December 2002 to November 2003 were enrolled and underwent endoscopic resection with SH. The usefulness of 0.4% SH was assessed by the en bloc complete resection and the formation and maintenance of mucosal lesion-lifting during endoscopic resection. Safety was evaluated by analyzing adverse events during the study period.
The usefulness rate was high (82.5%; 33/40). The following secondary outcome measures were noted: 1) steepness of mucosal lesion-lifting, 75.0% (30/40); 2) intraoperative complications, 10.0% (4/40); 3) time required for mucosal resection, 6.7 min; 4) volume of submucosal injection, 6.8 mL and 5) ease of mucosal resection, 87.5% (35/40). Two adverse events of bleeding potentially related to 0.4% SH were reported.
Using 0.4% SH solution enabled sufficient lifting of a colorectal intramucosal lesion during endoscopic resection, reducing the need for additional injections and the risk of perforation. Therefore, 0.4% SH may contribute to the reduction of complications and serve as a promising submucosal injection solution due to its potentially superior safety in comparison to normal saline solution.