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.
BACKGROUND
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.


METHODS
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.


RESULTS
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.


CONCLUSIONS
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.
Hirasaki
Shoji
S
Department of Internal Medicine, Sumitomo Besshi Hospital, Ehime, Japan. hirasaki@icknet.ne.jp
Kozu
Takahiro
T
Yamamoto
Hironori
H
Sano
Yasushi
Y
Yahagi
Naohisa
N
Oyama
Tsuneo
T
Shimoda
Tadakazu
T
Sugano
Kentaro
K
Tajiri
Hisao
H
Takekoshi
Takao
T
Saito
Daizo
D
D000368:Aged; D000369:Aged, 80 and over; D003110:Colonic Neoplasms / Q000473:pathology / Q000601:surgery*; D004724:Endoscopy / Q000379:methods*; D005260:Female; D006801:Humans; D006820:Hyaluronic Acid / Q000008:administration & dosage* / Q000009:adverse effects; D007267:Injections; D007413:Intestinal Mucosa; D007564:Japan; D008297:Male; D008875:Middle Aged; D009361:Neoplasm Invasiveness; D011446:Prospective Studies; D012004:Rectal Neoplasms / Q000473:pathology / Q000601:surgery*; D016896:Treatment Outcome; D055675:Viscosupplements / Q000008:administration & dosage* / Q000009:adverse effects
D055675:Viscosupplements; D006820:Hyaluronic Acid