Comparison of Effectiveness of TissuePatchTM in Preventing Postoperative Pancreatic Fistula
Randomized Controlled Trial for Comparison of the Effects of Preventing Postoperative Pancreatic Fistula by With Versus Without TissuePatchTM Cover the Wound Surface of Pancreatic Capsule
Xijing Hospital of Digestive Diseases
154 participants
Aug 1, 2022
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria6
- Histological confirmation of gastric adenocarcinoma
- Stage cT1-4a, N0-3, M0 (according to the 8th AJCC TNM staging system)
- For locally advanced tumors (cT3-4aN+M0), preoperative completion of all three cycles of chemotherapy (SOX)
- -75 years old
- No incurable factors such as cancer cell metastasis in other organs
- Written informed consent signed voluntarily
Exclusion Criteria9
- Assessment of preoperative or intraoperative requiring pancreatic resection
- Gastric cancer-related emergency surgery
- Gastric stump carcinoma
- In cases of distant metastasis discovered during operation, only abdominal exploration or palliative surgery were adopt.
- Uncontrolled seizures, central nervous system diseases or mental disorders
- Uncorrectable coagulation dysfunction
- Severe uncontrolled recurrent infections or other severe uncontrolled concomitant diseases
- Diseases requiring immunosuppressive treatment, such as organ transplantation, SLE, etc
- Other diseases requiring simultaneous surgery
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Interventions
Radical gastrectomy +D2 lymphadenectomy+TissuePatchTM to seal pancreatic tissue surface
Radical gastrectomy +D2 lymphadenectomy
Locations(1)
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NCT05404256