Usefulness and safety of 0.4% sodium hyaluronate solution as a submucosal fluid "cushion" in endoscopic resection for gastric neoplasms: a prospective multicenter trial

Hironori Yamamoto, Naohisa Yahagi, Tsuneo Oyama, Takuji Gotoda, Toshihiko Doi, Shoji Hirasaki, Tadakazu Shimoda, Kentaro Sugano, Hisao Tajiri, Takao Takekoshi, Daizo Saito

Research output: Contribution to journalArticle

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Abstract

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.

Original languageEnglish
Pages (from-to)830-839
Number of pages10
JournalGastrointestinal Endoscopy
Volume67
Issue number6
DOIs
Publication statusPublished - 2008 May
Externally publishedYes

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Hyaluronic Acid
Multicenter Studies
Stomach Neoplasms
Safety
Injections
Outcome Assessment (Health Care)
Stomach
Maintenance
Control Groups
Sodium Chloride
Japan
Referral and Consultation
Randomized Controlled Trials

ASJC Scopus subject areas

  • Gastroenterology

Cite this

Usefulness and safety of 0.4% sodium hyaluronate solution as a submucosal fluid "cushion" in endoscopic resection for gastric neoplasms : a prospective multicenter trial. / Yamamoto, Hironori; Yahagi, Naohisa; Oyama, Tsuneo; Gotoda, Takuji; Doi, Toshihiko; Hirasaki, Shoji; Shimoda, Tadakazu; Sugano, Kentaro; Tajiri, Hisao; Takekoshi, Takao; Saito, Daizo.

In: Gastrointestinal Endoscopy, Vol. 67, No. 6, 05.2008, p. 830-839.

Research output: Contribution to journalArticle

Yamamoto, Hironori ; Yahagi, Naohisa ; Oyama, Tsuneo ; Gotoda, Takuji ; Doi, Toshihiko ; Hirasaki, Shoji ; Shimoda, Tadakazu ; Sugano, Kentaro ; Tajiri, Hisao ; Takekoshi, Takao ; Saito, Daizo. / Usefulness and safety of 0.4% sodium hyaluronate solution as a submucosal fluid "cushion" in endoscopic resection for gastric neoplasms : a prospective multicenter trial. In: Gastrointestinal Endoscopy. 2008 ; Vol. 67, No. 6. pp. 830-839.
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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

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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