Comparison of Effectiveness of TissuePatchTM in Preventing Postoperative Pancreatic Fistula (NCT05404256) | Clinical Trial Compass
UnknownNot Applicable
Comparison of Effectiveness of TissuePatchTM in Preventing Postoperative Pancreatic Fistula
China154 participantsStarted 2022-08-01
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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)
* 18-75 years old
* No incurable factors such as cancer cell metastasis in other organs
* Written informed consent signed voluntarily
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of pancreatic fistula after radical gastrectomy