NCT06205693

Intraoperative Biodegradable Stent Placement to Reduce Complications After Pancreatoduodenectomy

Intraoperative Biodegradable Stent Placement to Reduce Complications After Pancreatoduodenectomy - Protocol and Statistical Analysis Plan for Randomized, Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Rigshospitalet, Denmark · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Fistula Pancreatic

Interventions

Type	Name	Description
PROCEDURE	Fast Degradable, Biodegradable ARCHEMEDES stent	Fast Degradable, Biodegradable ARCHEMEDES stent. Placed in the pancreaticojejunostomy.

Timeline

• Start date: 2023-10-01
• Primary completion: 2025-05-01
• Completion: 2025-05-01
• First posted: 2024-01-16
• Last updated: 2025-06-08

Locations

1 site across 1 country: Denmark