Actively Recruiting
Comparison of Effectiveness of TissuePatchTM in Preventing Postoperative Pancreatic Fistula
Led by Xijing Hospital of Digestive Diseases · Updated on 2024-05-08
154
Participants Needed
1
Research Sites
191 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Postoperative pancreatic fistula is one of the most serious complications after gastric cancer surgery and can lead to surgery-related death. Postoperative pancreatic fistula for gastric cancer often occurs in accidental injury of pancreas during peripancreatic lymph node dissection, blunt separation of pancreatic capsule injury, laparoscopic instrument clamp and long-term compression of pancreas, etc. TissePatchTM is a synthetic, self-adhesive, absorbable surgical sealant and barrier used to seal and reinforce wounds and prevent leakage of air, blood, and fluid during neurosurgery, spine, chest, and soft tissue surgery. Therefore, we proposed whether the use of TissuePatchTM can reduce the occurrence of pancreatic fistula after gastric cancer surgery, and the clinical trial of the effectiveness of TissuePatchTM on the prevention of pancreatic fistula after radical gastrectomy of gastric cancer can provide new clinical data for the prevention of pancreatic fistula after gastric cancer surgery, and help reduce a series of adverse reactions caused by pancreatic fistula in patients.
CONDITIONS
Official Title
Comparison of Effectiveness of TissuePatchTM in Preventing Postoperative Pancreatic Fistula
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histological confirmation of gastric adenocarcinoma
- Clinical stage cT1-4a, N0-3, M0 according to the 8th AJCC TNM staging system
- Completion of all three cycles of preoperative SOX chemotherapy for locally advanced tumors (cT3-4aN+M0)
- Age between 18 and 75 years
- No incurable factors such as cancer metastasis to other organs
- Voluntary written informed consent provided
You will not qualify if you...
- Requirement for pancreatic resection assessed before or during surgery
- Emergency surgery related to gastric cancer
- Gastric stump carcinoma
- Distant metastasis found during operation leading only to abdominal exploration or palliative surgery
- Uncontrolled seizures, central nervous system diseases, or mental disorders
- Uncorrectable coagulation problems
- Severe uncontrolled recurrent infections or other severe uncontrolled diseases
- Diseases needing immunosuppressive treatment, such as organ transplantation or systemic lupus erythematosus
- Other diseases requiring simultaneous surgery
AI-Screening
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Trial Site Locations
Total: 1 location
1
Xijing Hospital of Digestive Disease
Xi'an, Shaanxi, China, 710032
Actively Recruiting
Research Team
X
xiaohua Li, MD,PH.D
CONTACT
Z
zhenchang Mo
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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