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OpenTrials
Completed

NCT Number: NCT06205693

Intraoperative Biodegradable Stent Placement to Reduce Complications After Pancreatoduodenectomy

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rigshospitalet

Copenhagen, Capitol, 2100, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

Fast Degradable, Biodegradable ARCHEMEDES stent

Procedure

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

Primary outcomes

  1. POPF

    Time frame: 30 days

    Number of participants with a Postoperative pancreatic fistula

  2. Number of participants with a Biliary fistula

    Time frame: 30 days

    Postoperative biliary fistula

Secondary outcomes

  1. Complications to stent placement

    Time frame: 30 days

    Incidence of complications to placement of the biodegradable stent, including displacement.

  2. Postoperative complications

    Time frame: 30 days postoperative

    Overall incidence of complications following PD classified according to Clavien-Dindo

  3. Mortality

    Time frame: 30 days and 90 days

    Participant Mortality at 30 and 90 days

  4. LOS

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

    Participant Length of hospital stay (LOS).

  5. Quality of Life according to VR12 Quality of Life Score

    Time frame: 30 days post surgery

    Patient reported quality of life according to VR12 Quality of Life Score (activity level, pain episodes, pain levels, patient mood)

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Registry information

Official study title

Intraoperative Biodegradable Stent Placement to Reduce Complications After Pancreatoduodenectomy - Protocol and Statistical Analysis Plan for Randomized, Clinical Trial

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jan 16, 2024
Registry last updated
Jun 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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