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

• DOI: 10.1111/den.13352
• Publication Date: 2019-01-24T02:14:56Z
• Authors: 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
• Keywords: Endoscopic submucosal dissection; Sodium hyaluronate; Endoscopic mucosal resection

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