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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Stomach Neoplasm

Intervention / Treatment
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* Drug: Oozfix
* Drug: Greenplast


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Gastric adenocarcinoma patient who underwent radical gastrectomy at Bucheon St. Mary's Hospital Patient's Age is above 19 and less than 80 ECOG performance score : 0 2 Exclusion Criteria: Patient who underwent emergent gastrectomy Patient who requires palliative gastrectomy due to advanced or metastatic carcinoma Patient who requires operation due to other malignancy other than adenocrcinoma Patient who underwent emergent gastrectomy or pancreatectomy before this study Patient who underwent chemoradiation Patient who took anticoagulants or with coagulopathy

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oozfix<br>Arm with oozfix after gastrectomy | Drug: Oozfix<br>* Directly apply carboxymetyl starch (Oozfix) 5 gram evenly at the suprapancreatic surgical bed after gastrectomy<br>* Other names: Case group;|
| Active Comparator: Greenplast<br>Arm with greenplast after gastrectomy | Drug: Greenplast<br>* Directly apply Greenplast (Aprotinin 1000kIU/mL, Thrombin 500IU/mL, Fibrinogen 95mg/mL) 4 gram evenly at the suprapancreatic surgical bed after gastrectomy<br>* Other names: Control Group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ratio of (patient who suffers from) pancreatic fistula | Ratio of patient who suffers from pancreatic fistula | Postoperative day 3 |