BACKGROUND:Sodium hyaluronate (SH) solution has been used for submucosal injection in endoscopic resection to create a long-lasting submucosal fluid "cushion." OBJECTIVES: Our purpose was to assess the usefulness and safety of 0.4% SH solution in endoscopic resection. DESIGN: A prospective multicenter randomized controlled trial. SETTING:Six referral hospitals in Japan. PATIENTS: One hundred forty patients with 5- to 20-mm gastric intramucosal neoplastic lesions. INTERVENTIONS: Patients were randomized into 0.4% SH and control groups. Endoscopic resection was performed with 0.4% SH or normal saline solution for submucosal injection. PRIMARY OUTCOME MEASURE: The usefulness of 0.4% SH solution was assessed by en bloc complete resection and the formation and maintenance of mucosal lesion-lifting during endoscopic resection. SECONDARY OUTCOME MEASURES: (1) steepness of mucosal lesion lifting, (2) complications, (3) time required for mucosal resection, (4) volume of submucosal injection solution, and (5) ease of mucosal resection. Safety was assessed by analyzing adverse events during the study period. RESULTS: The usefulness rate was significantly higher for the 0.4% SH group (88.4%, 61/69) than for the control group (58.6%, 41/70). As secondary outcome measures, significant intergroup differences (P < .001) were noted for (1) steepness of mucosal lesion lifting, (2) volume of submucosal injection solution, and (3) ease of mucosal resection. No serious adverse events were encountered in either group. LIMITATIONS: Lack of blinding. Safety was not a powered outcome measure. CONCLUSIONS: Using 0.4% SH as a submucosal injection solution in endoscopic resection enabled the formation and maintenance of sufficient mucosal lesion lifting for gastric intramucosal lesions, reducing the need for additional injections and simplifying mucosal resection. Use of 0.4% SH thus simplifies the complicated procedures involved in endoscopic resection.
RCT Entities:
BACKGROUND:Sodium hyaluronate (SH) solution has been used for submucosal injection in endoscopic resection to create a long-lasting submucosal fluid "cushion." OBJECTIVES: Our purpose was to assess the usefulness and safety of 0.4% SH solution in endoscopic resection. DESIGN: A prospective multicenter randomized controlled trial. SETTING: Six referral hospitals in Japan. PATIENTS: One hundred forty patients with 5- to 20-mm gastric intramucosal neoplastic lesions. INTERVENTIONS:Patients were randomized into 0.4% SH and control groups. Endoscopic resection was performed with 0.4% SH or normal saline solution for submucosal injection. PRIMARY OUTCOME MEASURE: The usefulness of 0.4% SH solution was assessed by en bloc complete resection and the formation and maintenance of mucosal lesion-lifting during endoscopic resection. SECONDARY OUTCOME MEASURES: (1) steepness of mucosal lesion lifting, (2) complications, (3) time required for mucosal resection, (4) volume of submucosal injection solution, and (5) ease of mucosal resection. Safety was assessed by analyzing adverse events during the study period. RESULTS: The usefulness rate was significantly higher for the 0.4% SH group (88.4%, 61/69) than for the control group (58.6%, 41/70). As secondary outcome measures, significant intergroup differences (P < .001) were noted for (1) steepness of mucosal lesion lifting, (2) volume of submucosal injection solution, and (3) ease of mucosal resection. No serious adverse events were encountered in either group. LIMITATIONS: Lack of blinding. Safety was not a powered outcome measure. CONCLUSIONS: Using 0.4% SH as a submucosal injection solution in endoscopic resection enabled the formation and maintenance of sufficient mucosal lesion lifting for gastric intramucosal lesions, reducing the need for additional injections and simplifying mucosal resection. Use of 0.4% SH thus simplifies the complicated procedures involved in endoscopic resection.
Authors: D W Schölvinck; L Alvarez Herrero; O Goto; S L Meijer; H Neuhaus; B Schumacher; J J G H M Bergman; B L A M Weusten Journal: Surg Endosc Date: 2014-12-06 Impact factor: 4.584