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

Shoji Hirasaki, Takahiro Kozu, Hironori Yamamoto, Yasushi Sano, Naohisa Yahagi, Tsuneo Oyama, Tadakazu Shimoda, Kentaro Sugano, Hisao Tajiri, Takao Takekoshi, Daizo Saito

Research output: Contribution to journalArticle

25 Citations (Scopus)

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. Conclusion: 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.

Original languageEnglish
Article number1
JournalBMC Gastroenterology
Volume9
DOIs
Publication statusPublished - 2009 Jan 8
Externally publishedYes

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Hyaluronic Acid
Colorectal Neoplasms
Safety
Injections
Japan
Referral and Consultation
Endoscopic Mucosal Resection
Intraoperative Complications
Sodium Chloride
Stomach
Mucous Membrane
Maintenance
Outcome Assessment (Health Care)
Clinical Trials
Hemorrhage

ASJC Scopus subject areas

  • Gastroenterology

Cite this

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. / Hirasaki, Shoji; Kozu, Takahiro; Yamamoto, Hironori; Sano, Yasushi; Yahagi, Naohisa; Oyama, Tsuneo; Shimoda, Tadakazu; Sugano, Kentaro; Tajiri, Hisao; Takekoshi, Takao; Saito, Daizo.

In: BMC Gastroenterology, Vol. 9, 1, 08.01.2009.

Research output: Contribution to journalArticle

Hirasaki, Shoji ; Kozu, Takahiro ; Yamamoto, Hironori ; Sano, Yasushi ; Yahagi, Naohisa ; Oyama, Tsuneo ; Shimoda, Tadakazu ; Sugano, Kentaro ; Tajiri, Hisao ; Takekoshi, Takao ; Saito, Daizo. / 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. In: BMC Gastroenterology. 2009 ; Vol. 9.
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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{"}. 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. Conclusion: 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.",
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T2 - A prospective multi-center open-label trial

AU - Hirasaki, Shoji

AU - Kozu, Takahiro

AU - Yamamoto, Hironori

AU - Sano, Yasushi

AU - Yahagi, Naohisa

AU - Oyama, Tsuneo

AU - Shimoda, Tadakazu

AU - Sugano, Kentaro

AU - Tajiri, Hisao

AU - Takekoshi, Takao

AU - Saito, Daizo

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