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

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.

Study Overview

• Status: Completed
• Conditions: Fistula Pancreatic
• Intervention / Treatment: Procedure: Fast Degradable, Biodegradable ARCHEMEDES stent

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Capitol
    • Copenhagen, Capitol, Denmark, 2100
      • Rigshospitalet

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Stent; Placement of biodegradable stent intraoperatively.	Procedure: Fast Degradable, Biodegradable ARCHEMEDES stent; Fast Degradable, Biodegradable ARCHEMEDES stent. Placed in the pancreaticojejunostomy.
No Intervention: No stent; Control group. No placement of stent.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
POPF	Number of participants with a Postoperative pancreatic fistula	30 days
Number of participants with a Biliary fistula	Postoperative biliary fistula	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complications to stent placement	Incidence of complications to placement of the biodegradable stent, including displacement.	30 days
Postoperative complications	Overall incidence of complications following PD classified according to Clavien-Dindo	30 days postoperative
Mortality	Participant Mortality at 30 and 90 days	30 days and 90 days
LOS	Participant Length of hospital stay (LOS).	Length in days, from surgery until discharge ( up to 200 days from surgery)
Quality of Life according to VR12 Quality of Life Score	Patient reported quality of life according to VR12 Quality of Life Score (activity level, pain episodes, pain levels, patient mood)	30 days post surgery

Collaborators and Investigators

• Sponsor: Rigshospitalet, Denmark

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2023
• Primary Completion (Actual): May 1, 2025
• Study Completion (Actual): May 1, 2025

Study Registration Dates

• First Submitted: December 14, 2023
• First Submitted That Met QC Criteria: January 12, 2024
• First Posted (Actual): January 16, 2024

Study Record Updates

• Last Update Posted (Actual): June 8, 2025
• Last Update Submitted That Met QC Criteria: June 4, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Fistula; postoperative pancreatic fistula; pancreatoduodenectomy
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Digestive System Diseases; Pancreatic Diseases; Digestive System Fistula; Fistula; Pancreatic Fistula
• Other Study ID Numbers: Stent-trial

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No