Intraoperative Biodegradable Stent Placement to Reduce Complications After Pancreatoduodenectomy

Not Applicable

Recruiting

• 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

Study Timeline

• Study Start: 2023-10-01
• Study First Submitted: 2023-12-14
• Status Verified: 2024-01
• Study First Submitted QC: 2024-01-12
• Last Update Submitted: 2024-01-12
• Study First Posted: 2024-01-16
• Last Update Posted: 2024-01-16
• Primary Completion: 2024-07-01
• Study Completion: 2024-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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.

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