Intraoperative Biodegradable Stent Placement to Reduce Complications After Pancreatoduodenectomy

NCT06205693 | Completed DMC

• 1 other identifier: Stent-trial
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Fistula Pancreatic

Keywords

Fistula; postoperative pancreatic fistula; pancreatoduodenectomy

Outcome Measures

Primary Outcomes (2)

• POPF

  Number of participants with a Postoperative pancreatic fistula

  30 days

• Number of participants with a Biliary fistula

  Postoperative biliary fistula

  30 days

Secondary Outcomes (5)

• Complications to stent placement

  30 days

• Postoperative complications

  30 days postoperative

• Mortality

  30 days and 90 days

• LOS

  Length in days, from surgery until discharge ( up to 200 days from surgery)

• Quality of Life according to VR12 Quality of Life Score

  30 days post surgery

Study Arms (2)

Stent

ACTIVE COMPARATOR

Placement of biodegradable stent intraoperatively.

Procedure: Fast Degradable, Biodegradable ARCHEMEDES stent

No stent

NO INTERVENTION

Control group. No placement of stent.

Interventions

Fast Degradable, Biodegradable ARCHEMEDES stent PROCEDURE

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

Stent

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing a pancreatoduodenectomy
• Patients aged 18 or above
• Patients who have given an informed consent

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Rigshospitalet

Copenhagen, Capitol, 2100, Denmark

Location

MeSH Terms

Conditions

Pancreatic Fistula; Fistula

Condition Hierarchy (Ancestors)

Digestive System Fistula; Digestive System Diseases; Pancreatic Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The investigators will mask the allocation for the outcome assessors and trial statistician who will conduct the analyses, and the author group while writing the abstract for the trial report with the two intervention groups coded as 0 and 1. Due to the nature of the intervention and control, the trial will not be blinded for the surgeons performing the interventions
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Generel Surgeon

Model Details: prospective, randomized, blinded clinical superiority trial

Study Record Dates

• First Submitted: December 14, 2023
• First Posted: January 16, 2024
• Study Start: October 1, 2023
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: June 8, 2025

Record last verified: 2025-06

Locations

DK (1)