Stomach Neoplasm Clinical Trial
— OOZFIXOfficial 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.
Status | Recruiting |
Enrollment | 180 |
Est. completion date | January 31, 2025 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 19 Years to 80 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | BucheonStMarys | Bucheon-Si |
Lead Sponsor | Collaborator |
---|---|
Bucheon St. Mary's Hospital |
Korea, Republic of,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Ratio of (patient who suffers from) pancreatic fistula | Ratio of patient who suffers from pancreatic fistula | Postoperative day 3 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03313700 -
Clinical Outcomes of Robotic Versus Laparoscopic Distal Gastrectomy for Gastric Cancer
|
N/A | |
Completed |
NCT03549494 -
Evaluation of Ocoxin®-Viusid® in Advanced Stomach Cancer and Gastric Esophagogastric Junction
|
Phase 2 | |
Completed |
NCT00935779 -
Ultra Structure Of Peritoneum At Electronic Microscopy In Control Subjects And Patients With Gastric Cancer
|
N/A | |
Completed |
NCT00144378 -
Irinotecan Versus Only Best Supportive Care for Gastric Cancer
|
Phase 3 | |
Completed |
NCT00290966 -
Randomized Multicenter Study Comparing Docetaxel Plus Cisplatin and 5-FU to Cisplatin Plus 5-FU in Advanced Gastric Cancer
|
Phase 2/Phase 3 | |
Recruiting |
NCT03348150 -
Gastrectomy + Cytoreductive Surgery + HIPEC for Gastric Cancer With Peritoneal Dissemination.
|
Phase 3 | |
Not yet recruiting |
NCT06085677 -
The Gastric HormonE BioMarkers of Preneoplastic Lesions Study
|
||
Recruiting |
NCT02969122 -
Treatment Strategy for Stage IV Gastric Cancer With Positive Peritoneal Cytology as the Only Non-curable Factor
|
N/A | |
Completed |
NCT01482299 -
RAD001 in Advanced Gastric Cancer Who Failed Standard First-line Treatment With pS6 Ser 240/4 Expression
|
Phase 2 | |
Active, not recruiting |
NCT03760822 -
Second-Line Chemotherapy With Ramucirumab +/- Paclitaxel in Elderly Advanced Gastric or Gastroesophageal Junction Cancer Patients
|
Phase 2 | |
Recruiting |
NCT00509964 -
Second-Line Irinotecan vs. ILF for AGC
|
Phase 2 | |
Completed |
NCT04889859 -
Impact of Biliopancreatic Limb Length on Diabetes Following Distal Gastrectomy
|
N/A | |
Completed |
NCT03071237 -
The Origin of Infrapyloric Artery
|
||
Recruiting |
NCT05184803 -
A Phase 2 Study of Neoadjuvant Docetaxel, Oxaliplatin, S-1 in Patients With Unresectable Locally Advanced or Distant Metastasis Limited to Lymph Node Gastric Cancer
|
Phase 2 | |
Completed |
NCT05714878 -
Multimodal Prehabilitation for Resectable Gastric Cancer
|
N/A | |
Completed |
NCT00142038 -
Docetaxel and Capecitabine in Advanced Gastric Cancer
|
Phase 2 | |
Not yet recruiting |
NCT04056260 -
ICG-NIR Guided Lymph Node Dissection in Gastric Cancer
|
N/A | |
Recruiting |
NCT03065257 -
Endoscopic Resection Multicenter Registry
|
N/A | |
Recruiting |
NCT04744649 -
Neoadjuvant Immunotherapy and Chemotherapy for Locally Advanced Esophagogastric Junction and Gastric Cancer Trial
|
Phase 2 | |
Recruiting |
NCT05640609 -
Capeox Regimen Combined With Sintilimab and Bevacizumab for Gastric Cancer
|
Phase 1/Phase 2 |