Stomach NeoplasmPhase 4OOZFIXNCT05645198
The Effect of Carboxymetyl Starch (Oozfix) on Preventing Postoperative Complication After Gastrectomy
A Phase 4 study testing Oozfix and Greenplast in people with Stomach Neoplasm, run by Bucheon St. Mary's Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Stomach Neoplasm
- What is being tested?
- Oozfix and Greenplast
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteSouth Korea
- Study dates
- 26 Oct 2022to 31 Jan 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
BucheonStMarys
Bucheon-si
Hayemin Lee
About this study
Official title: 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.
Read the 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.
- Conditions
- Stomach Neoplasm
- Being tested
- Oozfix, Greenplast
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OozfixDrug
Also called Case group
Directly apply carboxymetyl starch (Oozfix) 5 gram evenly at the suprapancreatic surgical bed after gastrectomy
GreenplastDrug
Also called Control Group
Directly apply Greenplast (Aprotinin 1000kIU/mL, Thrombin 500IU/mL, Fibrinogen 95mg/mL) 4 gram evenly at the suprapancreatic surgical bed after gastrectomy
| Study group | Role | What they receive |
|---|---|---|
| Oozfix | Experimental | Arm with oozfix after gastrectomy Receives: Drug: Oozfix |
| Greenplast | Active comparator | Arm with greenplast after gastrectomy Receives: Drug: Greenplast |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ratio of (patient who suffers from) pancreatic fistula
Ratio of patient who suffers from pancreatic fistula
Measured: Postoperative day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2022
- Study start26 Oct 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stomach NeoplasmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bucheon St. Mary's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hayemin Lee, Bucheon St. Mary's Hospital
- Investigators
- Hayemin LEE, Study chair, Bucheon St. Mary's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05645198
- Sponsor's protocol ID
- HC22DISC0039
- Acronym
- OOZFIX
- Status last verified
- Dec 2022
- First submitted
- 15 Nov 2022
- Last updated
- 9 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 33319151
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Carboxymetyl Starch (Oozfix) on Preventing Postoperative Complication After Gastrectomy: Single-center, Non-inferiority, Open-label Randomized Trial
- ClinicalTrials.gov ID
- NCT05645198
- Acronym / sponsor ID
- OOZFIX / HC22DISC0039
- Conditions
- Stomach Neoplasm
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Bucheon St. Mary's HospitalUniversity, hospital or other
- Study start
- 26 Oct 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Jan 2025 (estimated)
- First posted
- 9 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oozfix | Experimental | Drug: OozfixArm with oozfix after gastrectomy |
| Greenplast | Active comparator | Drug: GreenplastArm with greenplast after gastrectomy |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OozfixAlso: Case groupDirectly apply carboxymetyl starch (Oozfix) 5 gram evenly at the suprapancreatic surgical bed after gastrectomy | Drug | Oozfix |
| GreenplastAlso: Control GroupDirectly apply Greenplast (Aprotinin 1000kIU/mL, Thrombin 500IU/mL, Fibrinogen 95mg/mL) 4 gram evenly at the suprapancreatic surgical bed after gastrectomy | Drug | Greenplast |
Primary outcome
Ratio of (patient who suffers from) pancreatic fistula
Time frame: Postoperative day 3
Ratio of patient who suffers from pancreatic fistula
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2022.
- Background: PubMed 33319151Washio 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hayemin LEE study chair
Bucheon St. Mary's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Oozfix and Greenplast in people with Stomach Neoplasm, run by Bucheon St. Mary's Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hayemin LEE (+82+032-340-7631, hymin@catholic.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ratio of (patient who suffers from) pancreatic fistula (time frame: Postoperative day 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05645198, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2022; AzTrials last refreshed its copy on 8 Nov 2026.