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Randomized Controlled Trial
, 31 (4), 396-404

Efficacy and Safety of 0.6% Sodium Alginate Solution in Endoscopic Submucosal Dissection for Esophageal and Gastric Neoplastic Lesion: A Randomized Controlled Study

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Randomized Controlled Trial

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 et al. Dig Endosc.

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.

Keywords: endoscopic submucosal dissection; gastric neoplasms; randomized controlled trials; sodium alginate; sodium hyaluronate.

Conflict of interest statement

The funding for this study was provided by Kaigen Pharma Corporation, Osaka, Japan, which is to receive approval for marketing of the medical device from the Ministry of Health Labor, and Welfare of Japan. The funding source had no role in the design, practice or analysis of this study. Kaigen Pharma Corporation contracted and paid all hospitals on the basis of good clinical practice.

Figures

Figure 1
Figure 1
Flow chart of the study. *1Excluded for the following reasons: one patient for withdrawal of consent and one patient for meeting exclusion criteria. *2Discontinued for the following reasons: two patients for withdrawal of consent and two patients for meeting exclusion criteria. *3Discontinued because of no neoplastic lesions by endoscopy. *4Discontinued for the following reasons: one patient for occurrence of an adverse event during the study, one patient for treatment of another lesion, two patients for performance of other treatments because of deeper submucosal invasion and one patient for no neoplastic lesions by histopathology.

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