title: 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.
abstract: 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.
authors.affiliation: Department of Internal Medicine, Sumitomo Besshi Hospital, Ehime, Japan. hirasaki@icknet.ne.jp
authors.forename: Shoji
authors.initials: S
authors.lastname: Hirasaki
authors.forename: Takahiro
authors.initials: T
authors.lastname: Kozu
authors.forename: Hironori
authors.initials: H
authors.lastname: Yamamoto
authors.forename: Yasushi
authors.initials: Y
authors.lastname: Sano
authors.forename: Naohisa
authors.initials: N
authors.lastname: Yahagi
authors.forename: Tsuneo
authors.initials: T
authors.lastname: Oyama
authors.forename: Tadakazu
authors.initials: T
authors.lastname: Shimoda
authors.forename: Kentaro
authors.initials: K
authors.lastname: Sugano
authors.forename: Hisao
authors.initials: H
authors.lastname: Tajiri
authors.forename: Takao
authors.initials: T
authors.lastname: Takekoshi
authors.forename: Daizo
authors.initials: D
authors.lastname: Saito
mesh_terms: 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
chemical_list: D055675:Viscosupplements; D006820:Hyaluronic Acid