Clinical trial · Interventional
The Effect of Carboxymetyl Starch (Oozfix) on Preventing Postoperative Complication After Gastrectomy
The Effect of Carboxymetyl Starch (Oozfix) on Preventing Postoperative Complication After Gastrectomy: Single-center, Non-inferiority, Open-label Randomized Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Stomach Neoplasm | Gastric Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Greenplast | Drug | — | UNRESOLVED |
| Oozfix | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Oozfix
- description
- Arm with oozfix after gastrectomy
- interventionNames
- Drug: Oozfix
- type
- ACTIVE_COMPARATOR
- label
- Greenplast
- description
- Arm with greenplast after gastrectomy
- interventionNames
- Drug: Greenplast
Primary outcomes (1)
- measure
- Ratio of (patient who suffers from) pancreatic fistula
- timeFrame
- Postoperative day 3
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (1)
- BACKGROUNDWashio 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