TY - JOUR
T1 - Usefulness and safety of 0.4% sodium hyaluronate solution as a submucosal fluid "cushion" in endoscopic resection for gastric neoplasms
T2 - a prospective multicenter trial
AU - Yamamoto, Hironori
AU - Yahagi, Naohisa
AU - Oyama, Tsuneo
AU - Gotoda, Takuji
AU - Doi, Toshihiko
AU - Hirasaki, Shoji
AU - Shimoda, Tadakazu
AU - Sugano, Kentaro
AU - Tajiri, Hisao
AU - Takekoshi, Takao
AU - Saito, Daizo
N1 - Funding Information:
The following authors report that they have no disclosures relevant to this publication: N. Yahagi, T. Oyama, T. Gotoda, T. Doi, S. Hirasaki, T. Shimoda, D. Saito. H. Yamamoto holds a patent entitled “Method of endoscopic mucosal resection using mucopolysacharide and local injection preparation” filed on May 16, 2000 (U.S. Patent No. 6,319,260). T. Takekoshi, K. Sugano, and H. Tajiri had a financial relationship with Seikagaku Corporation as consultancies for this study. Seikagaku Corporation, Tokyo, Japan, which is to receive approval for manufacture of the medical device from the Ministry of Health, Labor, and Welfare of Japan, supported this clinical study. Seikgaku Corporation contracted and paid all hospitals on the basis of good clinical practice as a clinical trial .
PY - 2008/5
Y1 - 2008/5
N2 - 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. Main Outcome Measurements: 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.
AB - 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. Main Outcome Measurements: 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.
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U2 - 10.1016/j.gie.2007.07.039
DO - 10.1016/j.gie.2007.07.039
M3 - Article
C2 - 18155216
AN - SCOPUS:42649129870
SN - 0016-5107
VL - 67
SP - 830
EP - 839
JO - Gastrointestinal Endoscopy
JF - Gastrointestinal Endoscopy
IS - 6
ER -