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

Bucheon St. Mary's Hospital

Status and phase: Enrolling; Phase 4

Conditions: Stomach Neoplasm

Treatments: Drug: Greenplast; Drug: Oozfix

Study type: Interventional

Funder types: Other

Identifiers

NCT05645198

HC22DISC0039

Details and patient eligibility

About

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.

Full 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.

Enrollment: 180 estimated patients

Sex: All

Ages: 19 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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180 participants in 2 patient groups

Oozfix

Experimental group

Description:

Arm with oozfix after gastrectomy

Treatment:

Drug: Oozfix

Greenplast

Active Comparator group

Description:

Arm with greenplast after gastrectomy

Treatment:

Drug: Greenplast