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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Stomach Neoplasm
• Intervention / Treatment: Drug: Oozfix; Drug: Greenplast

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.

• Study Type: Interventional
• Enrollment (Anticipated): 180
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Hayemin LEE; Phone Number: +82+032-340-7631; Email: hymin@catholic.ac.kr

Study Locations

• Korea, Republic of
  • Bucheon-Si, Korea, Republic of
    • Recruiting
    • BucheonStMarys
    • Contact: Hayemin Lee

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

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

Publications and helpful links

General Publications

• Washio M, Yamashita K, Niihara M, Hosoda K, Hiki N. Postoperative pancreatic fistula after gastrectomy for gastric cancer. Ann Gastroenterol Surg. 2020 Sep 21;4(6):618-627. doi: 10.1002/ags3.12398. eCollection 2020 Nov. Review.

Study record dates

Study Major Dates

• Study Start (Actual): October 26, 2022
• Primary Completion (Anticipated): December 31, 2024
• Study Completion (Anticipated): January 31, 2025

Study Registration Dates

• First Submitted: November 15, 2022
• First Submitted That Met QC Criteria: December 8, 2022
• First Posted (Estimate): December 9, 2022

Study Record Updates

• Last Update Posted (Estimate): December 9, 2022
• Last Update Submitted That Met QC Criteria: December 8, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms; Postoperative Complications
• Other Study ID Numbers: HC22DISC0039

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No