Spots Global Cancer Trial Database for The Effect of Carboxymetyl Starch (Oozfix) on Preventing Postoperative Complication After Gastrectomy

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Trial Identification

Brief Title: The Effect of Carboxymetyl Starch (Oozfix) on Preventing Postoperative Complication After Gastrectomy

Official Title: The Effect of Carboxymetyl Starch (Oozfix) on Preventing Postoperative Complication After Gastrectomy: Single-center, Non-inferiority, Open-label Randomized Trial

Study ID: NCT05645198

Conditions

Stomach Neoplasm

Interventions

Oozfix

Greenplast

Study Description

Brief Summary: Although the technique of radical gastrectomy had been advanced, postoperative complication can occur in 13\~25% of patient after radical gastrectomy. Pancreatic fistula and postoperative bleeding was reported as 2\~30% and 1\~2%, respectively. These complications often result fatal clinical course, so localized fibrin agent has been widely used at postoperative surgical bed after radical gastrectomy. Recently, natural origin polysaccharide-based carboxymetyl starch was approved as localized coagulative, no well-designed report was adressed in gastric cancer surgery field. This agent can formate physical barrier after application, thus can prevent microbleeding or pancreatic fistula after gastrectomy. THIS study is single-center, non-inferiority, open-label randomized trial that evaluates the effect of carboxymetyl starch (Oozfix) on preventing postoperative complication after gastrectomy.

Detailed Description: Although the technique of radical gastrectomy had been advanced, postoperative complication can occur in 13\~25% of patient after radical gastrectomy. Pancreatic fistula and postoperative bleeding was reported as 2\~30% and 1\~2%, respectively. These complications often result fatal clinical course, so localized fibrin agent has been widely used at postoperative surgical bed after radical gastrectomy. Recently, natural origin polysaccharide-based carboxymetyl starch was approved as localized coagulative, no well-designed report was adressed in gastric cancer surgery field. This agent can formate physical barrier after application, thus can prevent microbleeding or pancreatic fistula after gastrectomy. THIS study is single-center, non-inferiority, open-label randomized trial that evaluates the effect of carboxymetyl starch (Oozfix) on preventing postoperative complication after gastrectomy.