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Intraoperative Biodegradable Stent Placement to Reduce Complications After Pancreatoduodenectomy

NCT06205693 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-06-08

No results posted yet for this study

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

PROCEDURE

Fast Degradable, Biodegradable ARCHEMEDES stent

Fast Degradable, Biodegradable ARCHEMEDES stent. Placed in the pancreaticojejunostomy.

Sponsors & Collaborators

  • Rigshospitalet, Denmark

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-01
Primary Completion
2025-05-01
Completion
2025-05-01

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06205693 on ClinicalTrials.gov