NCT06205693
Completed
N/A
Intraoperative Biodegradable Stent Placement to Reduce Complications After Pancreatoduodenectomy - Protocol and Statistical Analysis Plan for Randomized, Clinical Trial
ConditionsFistula Pancreatic
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Fistula Pancreatic
- Sponsor
- Rigshospitalet, Denmark
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- POPF
- Status
- Completed
- Last Updated
- 10 months ago
Overview
Brief Summary
The aim of this prospective, randomized, blinded clinical superiority trial is to establish intraoperative placement of biodegradable stents in the pancreatojejunostomy as a safe, effective, and feasible preventive measure against pancreatic fistula following pancreatoduodenectomy.
The investigators hypothesize that intraoperative placement of biodegradable stents in the pancreatojejunostomy is safe and can reduce the risk of pancreatic leakage following pancreatoduodenectomy in patients who have not undergone PBD.
Investigators
Waqas Farooqui
Generel Surgeon
Rigshospitalet, Denmark
Eligibility Criteria
Inclusion Criteria
- •Patients undergoing a pancreatoduodenectomy
- •Patients aged 18 or above
- •Patients who have given an informed consent
Exclusion Criteria
- •Patients who do not or cannot give an informed consent.
- •Patients with at a high risk or with previous history of multiple thrombo-embolic diseases or bleeding disorders.
- •Patients undergoing active immunosuppressive therapy.
Outcomes
Primary Outcomes
POPF
Time Frame: 30 days
Number of participants with a Postoperative pancreatic fistula
Number of participants with a Biliary fistula
Time Frame: 30 days
Postoperative biliary fistula
Secondary Outcomes
- Mortality(30 days and 90 days)
- LOS(Length in days, from surgery until discharge ( up to 200 days from surgery))
- Complications to stent placement(30 days)
- Postoperative complications(30 days postoperative)
- Quality of Life according to VR12 Quality of Life Score(30 days post surgery)
Study Sites (1)
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