Efficacy and safety of 0.6% sodium alginate solution in endoscopic submucosal dissection for esophageal and gastric neoplastic lesion: A randomized controlled study

Naomi Uemura, Ichiro Oda, Yutaka Saito, Hiroyuki Ono, Junko Fujisaki, Nobuyuki Matsuhashi, Ken Ohata, Naohisa Yahagi, Tomoyuki Yada, Masahiro Satoh, Hisao Tajiri, Masafumi Inomata, Seigo Kitano

Research output: Contribution to journalArticle

3 Citations (Scopus)

Abstract

Objectives: Sodium alginate (SA) solution has characteristic viscoelasticity. We aimed to determine efficacy and safety of 0.6% SA for submucosal injection during endoscopic submucosal dissection (ESD) in patients with localized neoplastic lesion in the esophageal and gastric mucosa. Methods: We conducted a randomized controlled study at six major hospitals in Japan including 130 patients with endoscopically localized neoplastic lesion in the esophageal and gastric mucosa and eligible for ESD. Patients were randomly assigned to SA or 0.4% sodium hyaluronate (SH) group (control); ESD was performed using a submucosal injection of SA/SH. As a primary outcome measure, non-inferiority of SA against SH was investigated using en bloc complete resection in ESD and formation and maintenance of mucosal elevation upon injection as an efficacy index. Adverse events during the study were evaluated as safety outcome measures. This study was registered with Pharmaceuticals and Medical Devices Agency (clinical trial no. 28-277/2016-18; clinical trial identification no. KP2013-009_C001). Results: Efficacy rate of submucosal injection during ESD was 91.7% (55/60) and 88.7% (55/62) in the SA and SH groups, respectively, demonstrating non-inferiority of SA against SH. Adverse events for which a causal relationship with submucosal injection solution could not be eliminated were noted in 8.2% (5/61) and 4.7% (3/64) in the SA and SH groups, respectively, but symptoms disappeared without treatment/after drug administration in both groups. Conclusions: In Japan, 0.4% SH is the only commercially approved formulation for submucosal injection during ESD. The study results may expand submucosal injection solution options in clinical practice.

Original languageEnglish
JournalDigestive Endoscopy
DOIs
Publication statusPublished - 2019 Jan 1

Fingerprint

Hyaluronic Acid
Stomach
Safety
Injections
Gastric Mucosa
Japan
Outcome Assessment (Health Care)
Clinical Trials
alginic acid
Endoscopic Mucosal Resection
Pharmaceutical Preparations
Maintenance
Equipment and Supplies
Control Groups

Keywords

  • endoscopic submucosal dissection
  • gastric neoplasms
  • randomized controlled trials
  • sodium alginate
  • sodium hyaluronate

ASJC Scopus subject areas

  • Radiology Nuclear Medicine and imaging
  • Gastroenterology

Cite this

Efficacy and safety of 0.6% sodium alginate solution in endoscopic submucosal dissection for esophageal and gastric neoplastic lesion : A randomized controlled study. / Uemura, Naomi; Oda, Ichiro; Saito, Yutaka; Ono, Hiroyuki; Fujisaki, Junko; Matsuhashi, Nobuyuki; Ohata, Ken; Yahagi, Naohisa; Yada, Tomoyuki; Satoh, Masahiro; Tajiri, Hisao; Inomata, Masafumi; Kitano, Seigo.

In: Digestive Endoscopy, 01.01.2019.

Research output: Contribution to journalArticle

Uemura, Naomi ; Oda, Ichiro ; Saito, Yutaka ; Ono, Hiroyuki ; Fujisaki, Junko ; Matsuhashi, Nobuyuki ; Ohata, Ken ; Yahagi, Naohisa ; Yada, Tomoyuki ; Satoh, Masahiro ; Tajiri, Hisao ; Inomata, Masafumi ; Kitano, Seigo. / Efficacy and safety of 0.6% sodium alginate solution in endoscopic submucosal dissection for esophageal and gastric neoplastic lesion : A randomized controlled study. In: Digestive Endoscopy. 2019.
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abstract = "Objectives: Sodium alginate (SA) solution has characteristic viscoelasticity. We aimed to determine efficacy and safety of 0.6{\%} SA for submucosal injection during endoscopic submucosal dissection (ESD) in patients with localized neoplastic lesion in the esophageal and gastric mucosa. Methods: We conducted a randomized controlled study at six major hospitals in Japan including 130 patients with endoscopically localized neoplastic lesion in the esophageal and gastric mucosa and eligible for ESD. Patients were randomly assigned to SA or 0.4{\%} sodium hyaluronate (SH) group (control); ESD was performed using a submucosal injection of SA/SH. As a primary outcome measure, non-inferiority of SA against SH was investigated using en bloc complete resection in ESD and formation and maintenance of mucosal elevation upon injection as an efficacy index. Adverse events during the study were evaluated as safety outcome measures. This study was registered with Pharmaceuticals and Medical Devices Agency (clinical trial no. 28-277/2016-18; clinical trial identification no. KP2013-009_C001). Results: Efficacy rate of submucosal injection during ESD was 91.7{\%} (55/60) and 88.7{\%} (55/62) in the SA and SH groups, respectively, demonstrating non-inferiority of SA against SH. Adverse events for which a causal relationship with submucosal injection solution could not be eliminated were noted in 8.2{\%} (5/61) and 4.7{\%} (3/64) in the SA and SH groups, respectively, but symptoms disappeared without treatment/after drug administration in both groups. Conclusions: In Japan, 0.4{\%} SH is the only commercially approved formulation for submucosal injection during ESD. The study results may expand submucosal injection solution options in clinical practice.",
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T1 - Efficacy and safety of 0.6% sodium alginate solution in endoscopic submucosal dissection for esophageal and gastric neoplastic lesion

T2 - A randomized controlled study

AU - Uemura, Naomi

AU - Oda, Ichiro

AU - Saito, Yutaka

AU - Ono, Hiroyuki

AU - Fujisaki, Junko

AU - Matsuhashi, Nobuyuki

AU - Ohata, Ken

AU - Yahagi, Naohisa

AU - Yada, Tomoyuki

AU - Satoh, Masahiro

AU - Tajiri, Hisao

AU - Inomata, Masafumi

AU - Kitano, Seigo

PY - 2019/1/1

Y1 - 2019/1/1

N2 - Objectives: Sodium alginate (SA) solution has characteristic viscoelasticity. We aimed to determine efficacy and safety of 0.6% SA for submucosal injection during endoscopic submucosal dissection (ESD) in patients with localized neoplastic lesion in the esophageal and gastric mucosa. Methods: We conducted a randomized controlled study at six major hospitals in Japan including 130 patients with endoscopically localized neoplastic lesion in the esophageal and gastric mucosa and eligible for ESD. Patients were randomly assigned to SA or 0.4% sodium hyaluronate (SH) group (control); ESD was performed using a submucosal injection of SA/SH. As a primary outcome measure, non-inferiority of SA against SH was investigated using en bloc complete resection in ESD and formation and maintenance of mucosal elevation upon injection as an efficacy index. Adverse events during the study were evaluated as safety outcome measures. This study was registered with Pharmaceuticals and Medical Devices Agency (clinical trial no. 28-277/2016-18; clinical trial identification no. KP2013-009_C001). Results: Efficacy rate of submucosal injection during ESD was 91.7% (55/60) and 88.7% (55/62) in the SA and SH groups, respectively, demonstrating non-inferiority of SA against SH. Adverse events for which a causal relationship with submucosal injection solution could not be eliminated were noted in 8.2% (5/61) and 4.7% (3/64) in the SA and SH groups, respectively, but symptoms disappeared without treatment/after drug administration in both groups. Conclusions: In Japan, 0.4% SH is the only commercially approved formulation for submucosal injection during ESD. The study results may expand submucosal injection solution options in clinical practice.

AB - Objectives: Sodium alginate (SA) solution has characteristic viscoelasticity. We aimed to determine efficacy and safety of 0.6% SA for submucosal injection during endoscopic submucosal dissection (ESD) in patients with localized neoplastic lesion in the esophageal and gastric mucosa. Methods: We conducted a randomized controlled study at six major hospitals in Japan including 130 patients with endoscopically localized neoplastic lesion in the esophageal and gastric mucosa and eligible for ESD. Patients were randomly assigned to SA or 0.4% sodium hyaluronate (SH) group (control); ESD was performed using a submucosal injection of SA/SH. As a primary outcome measure, non-inferiority of SA against SH was investigated using en bloc complete resection in ESD and formation and maintenance of mucosal elevation upon injection as an efficacy index. Adverse events during the study were evaluated as safety outcome measures. This study was registered with Pharmaceuticals and Medical Devices Agency (clinical trial no. 28-277/2016-18; clinical trial identification no. KP2013-009_C001). Results: Efficacy rate of submucosal injection during ESD was 91.7% (55/60) and 88.7% (55/62) in the SA and SH groups, respectively, demonstrating non-inferiority of SA against SH. Adverse events for which a causal relationship with submucosal injection solution could not be eliminated were noted in 8.2% (5/61) and 4.7% (3/64) in the SA and SH groups, respectively, but symptoms disappeared without treatment/after drug administration in both groups. Conclusions: In Japan, 0.4% SH is the only commercially approved formulation for submucosal injection during ESD. The study results may expand submucosal injection solution options in clinical practice.

KW - endoscopic submucosal dissection

KW - gastric neoplasms

KW - randomized controlled trials

KW - sodium alginate

KW - sodium hyaluronate

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