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NCT05645198
The Effect of Carboxymetyl Starch (Oozfix) on Preventing Postoperative Complication After Gastrectomy
Conditions: Stomach Neoplasm
Sex: All
Ages: 19 Years – 80 Years
Phase: PHASE4
Enrollment: 180
Sponsor: Bucheon St. Mary's Hospital
Location: Korea, Republic of
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.
Eligibility Criteria
Inclusion Criteria:Gastric adenocarcinoma patient who underwent radical gastrectomy at Bucheon St. Mary's HospitalPatient's Age is above 19 and less than 80ECOG performance score : 0~2Exclusion Criteria:Patient who underwent emergent gastrectomyPatient who requires palliative gastrectomy due to advanced or metastatic carcinomaPatient who requires operation due to other malignancy other than adenocrcinomaPatient who underwent emergent gastrectomy or pancreatectomy before this studyPatient who underwent chemoradiationPatient who took anticoagulants or with coagulopathy
Source: ClinicalTrials.gov (NCT05645198). StuddyBuddy aggregates publicly available trial information.