Intraoperative Biodegradable Stent Placement to Reduce Complications After Pancreatoduodenectomy

Rigshospitalet

Status: Completed

Conditions: Fistula Pancreatic

Treatments: Procedure: Fast Degradable, Biodegradable ARCHEMEDES stent

Study type: Interventional

Funder types: Other

Identifiers

NCT06205693

Stent-trial

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients undergoing a pancreatoduodenectomy
2. Patients aged 18 or above
3. Patients who have given an informed consent

Exclusion criteria

1. Patients who do not or cannot give an informed consent.
2. Patients with at a high risk or with previous history of multiple thrombo-embolic diseases or bleeding disorders.
3. Patients undergoing active immunosuppressive therapy.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups

Stent

Active Comparator group

Description:

Placement of biodegradable stent intraoperatively.

Treatment:

Procedure: Fast Degradable, Biodegradable ARCHEMEDES stent

No stent

No Intervention group

Description:

Control group. No placement of stent.