Intraoperative Biodegradable Stent Placement to Reduce Complications After Pancreatoduodenectomy
NCT ID: NCT06205693
Last Updated: 2025-06-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
50 participants
INTERVENTIONAL
2023-10-01
2025-05-01
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Stent
Placement of biodegradable stent intraoperatively.
Fast Degradable, Biodegradable ARCHEMEDES stent
Fast Degradable, Biodegradable ARCHEMEDES stent. Placed in the pancreaticojejunostomy.
No stent
Control group. No placement of stent.
No interventions assigned to this group
Interventions
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Fast Degradable, Biodegradable ARCHEMEDES stent
Fast Degradable, Biodegradable ARCHEMEDES stent. Placed in the pancreaticojejunostomy.
Eligibility Criteria
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Inclusion Criteria
2. Patients aged 18 or above
3. Patients who have given an informed consent
Exclusion Criteria
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.
18 Years
ALL
No
Sponsors
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Rigshospitalet, Denmark
OTHER
Responsible Party
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Waqas Farooqui
Generel Surgeon
Locations
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Rigshospitalet
Copenhagen, Capitol, Denmark
Countries
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Other Identifiers
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Stent-trial
Identifier Type: -
Identifier Source: org_study_id
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