Stomach Neoplasm
Conditions
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.
Interventions
DRUGOozfix
Directly apply carboxymetyl starch (Oozfix) 5 gram evenly at the suprapancreatic surgical bed after gastrectomy
DRUGGreenplast
Directly apply Greenplast (Aprotinin 1000kIU/mL, Thrombin 500IU/mL, Fibrinogen 95mg/mL) 4 gram evenly at the suprapancreatic surgical bed after gastrectomy
Sponsors
Bucheon St. Mary's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Gastric adenocarcinoma patient who underwent radical gastrectomy at Bucheon St. Mary's Hospital 2. Patient's Age is above 19 and less than 80 3. ECOG performance score : 0\ 2
Exclusion criteria
1. Patient who underwent emergent gastrectomy 2. Patient who requires palliative gastrectomy due to advanced or metastatic carcinoma 3. Patient who requires operation due to other malignancy other than adenocrcinoma 4. Patient who underwent emergent gastrectomy or pancreatectomy before this study 5. Patient who underwent chemoradiation 6. Patient who took anticoagulants or with coagulopathy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ratio of (patient who suffers from) pancreatic fistula | Postoperative day 3 | Ratio of patient who suffers from pancreatic fistula |
Countries
South Korea
Contacts
Primary ContactHayemin LEE
Outcome results
None listed