Usefulness and safety of 0.4% sodium hyaluronate solution as a submucosal fluid "cushion" in endoscopic resection for gastric neoplasms: a prospective multicenter trial.
BACKGROUND
Sodium hyaluronate (SH) solution has been used for submucosal injection in endoscopic resection to create a long-lasting submucosal fluid "cushion."


OBJECTIVE
Our purpose was to assess the usefulness and safety of 0.4% SH solution in endoscopic resection.


METHODS
A prospective multicenter randomized controlled trial.


METHODS
Six referral hospitals in Japan.


METHODS
One hundred forty patients with 5- to 20-mm gastric intramucosal neoplastic lesions.


METHODS
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.


METHODS



METHODS
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.


METHODS
(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.


CONCLUSIONS
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.
D000276:Adjuvants, Immunologic / Q000008:administration & dosage*; D000368:Aged; D016099:Endoscopy, Gastrointestinal / Q000379:methods*; D005260:Female; D005500:Follow-Up Studies; D005743:Gastrectomy / Q000379:methods*; D005753:Gastric Mucosa; D006801:Humans; D006820:Hyaluronic Acid / Q000008:administration & dosage*; D015552:Injections, Intralesional; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D011446:Prospective Studies; D013274:Stomach Neoplasms / Q000188:drug therapy / Q000473:pathology / Q000601:surgery*; D016896:Treatment Outcome
D000276:Adjuvants, Immunologic; D006820:Hyaluronic Acid