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

Sponsor
Bucheon St. Mary's Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05645198
Collaborator
(none)
180
Enrollment
1
Location
2
Arms
27.2
Anticipated Duration (Months)
6.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Although the technique of radical gastrectomy had been advanced, postoperative complication can occur in 1325% of patient after radical gastrectomy. Pancreatic fistula and postoperative bleeding was reported as 230% 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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Detailed Description

Although the technique of radical gastrectomy had been advanced, postoperative complication can occur in 1325% of patient after radical gastrectomy. Pancreatic fistula and postoperative bleeding was reported as 230% 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
180 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
The Effect of Carboxymetyl Starch (Oozfix) on Preventing Postoperative Complication After Gastrectomy: Single-center, Non-inferiority, Open-label Randomized Trial
Actual Study Start Date :
Oct 26, 2022
Anticipated Primary Completion Date :
Dec 31, 2024
Anticipated Study Completion Date :
Jan 31, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Oozfix

Arm with oozfix after gastrectomy

Drug: Oozfix
Directly apply carboxymetyl starch (Oozfix) 5 gram evenly at the suprapancreatic surgical bed after gastrectomy
Other Names:
  • Case group

    		•
    Active Comparator: Greenplast

    Arm with greenplast after gastrectomy

    Drug: Greenplast
    Directly apply Greenplast (Aprotinin 1000kIU/mL, Thrombin 500IU/mL, Fibrinogen 95mg/mL) 4 gram evenly at the suprapancreatic surgical bed after gastrectomy
    Other Names:
  • Control Group

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Ratio of (patient who suffers from) pancreatic fistula [Postoperative day 3]

      Ratio of patient who suffers from pancreatic fistula

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 BucheonStMarys Bucheon-Si Korea, Republic of

    Sponsors and Collaborators

    • Bucheon St. Mary's Hospital

    Investigators

    • Study Chair: Hayemin LEE, Bucheon St. Mary's Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Hayemin Lee, Assistant Professor, Bucheon St. Mary's Hospital
    ClinicalTrials.gov Identifier:
    NCT05645198
    Other Study ID Numbers:
    • HC22DISC0039
    First Posted:
    Dec 9, 2022
    Last Update Posted:
    Dec 9, 2022
    Last Verified:
    Dec 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Stomach Neoplasms
    Postoperative Complications

    Study Results

    No Results Posted as of Dec 9, 2022