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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

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
GroupInterventionDescription
StentFast Degradable, Biodegradable ARCHEMEDES stentPlacement of biodegradable stent intraoperatively.
Primary Outcome Measures
NameTimeMethod
POPF30 days

Number of participants with a Postoperative pancreatic fistula

Number of participants with a Biliary fistula30 days

Postoperative biliary fistula

Secondary Outcome Measures
NameTimeMethod
LOSLength in days, from surgery until discharge ( up to 200 days from surgery)

Participant Length of hospital stay (LOS).

Mortality30 days and 90 days

Participant Mortality at 30 and 90 days

Complications to stent placement30 days

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

Postoperative complications30 days postoperative

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

Quality of Life according to VR12 Quality of Life Score30 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

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