Intraoperative Biodegradable Stent Placement to Reduce Complications After Pancreatoduodenectomy
- Conditions
- Fistula Pancreatic
- Interventions
- Procedure: Fast Degradable, Biodegradable ARCHEMEDES stent
- Registration Number
- NCT06205693
- Lead Sponsor
- Rigshospitalet, Denmark
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 50
- Patients undergoing a pancreatoduodenectomy
- Patients aged 18 or above
- Patients who have given an informed consent
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Stent Fast Degradable, Biodegradable ARCHEMEDES stent Placement of biodegradable stent intraoperatively.
- Primary Outcome Measures
Name Time Method POPF 30 days Number of participants with a Postoperative pancreatic fistula
Number of participants with a Biliary fistula 30 days Postoperative biliary fistula
- Secondary Outcome Measures
Name Time Method LOS Length in days, from surgery until discharge ( up to 200 days from surgery) Participant Length of hospital stay (LOS).
Mortality 30 days and 90 days Participant Mortality at 30 and 90 days
Complications to stent placement 30 days Incidence of complications to placement of the biodegradable stent, including displacement.
Postoperative complications 30 days postoperative Overall incidence of complications following PD classified according to Clavien-Dindo
Quality of Life according to VR12 Quality of Life Score 30 days post surgery Patient reported quality of life according to VR12 Quality of Life Score (activity level, pain episodes, pain levels, patient mood)
Trial Locations
- Locations (1)
Rigshospitalet
🇩🇰Copenhagen, Capitol, Denmark