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

NCT05645198 | Unknown Phase 4 DMC

• 1 other identifier: HC22DISC0039
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Stomach Neoplasm

Outcome Measures

Primary Outcomes (1)

• Ratio of (patient who suffers from) pancreatic fistula

  Ratio of patient who suffers from pancreatic fistula

  Postoperative day 3

Study Arms (2)

Oozfix

EXPERIMENTAL

Arm with oozfix after gastrectomy

Drug: Oozfix

Greenplast

ACTIVE COMPARATOR

Arm with greenplast after gastrectomy

Drug: Greenplast

Interventions

Oozfix DRUG

Directly apply carboxymetyl starch (Oozfix) 5 gram evenly at the suprapancreatic surgical bed after gastrectomy

Also known as: Case group

Oozfix

Greenplast DRUG

Directly apply Greenplast (Aprotinin 1000kIU/mL, Thrombin 500IU/mL, Fibrinogen 95mg/mL) 4 gram evenly at the suprapancreatic surgical bed after gastrectomy

Also known as: Control Group

Greenplast

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bucheon St. Mary's Hospital: lead

Study Sites (1)

BucheonStMarys

Bucheon-si, South Korea

RECRUITING

Related Publications (1)

• 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.

  PMID: 33319151 BACKGROUND

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Diagnosis-Related Groups; Control Groups

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Prospective Payment System; Reimbursement Mechanisms; Insurance, Health, Reimbursement; Financing, Organized; Economics; Health Care Economics and Organizations; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Hayemin LEE

  Bucheon St. Mary's Hospital

  STUDY CHAIR

Central Study Contacts

Hayemin LEE

CONTACT

+82+032-340-7631; hymin@catholic.ac.kr

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 15, 2022
• First Posted: December 9, 2022
• Study Start: October 26, 2022
• Primary Completion: December 31, 2024
• Study Completion: January 31, 2025
• Last Updated: December 9, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)