Intraoperative Biodegradable Stent Placement to Reduce Complications After Pancreatoduodenectomy

NCT ID: NCT06205693

Last Updated: 2025-06-08

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-01

Study Completion Date

2025-05-01

Brief Summary

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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

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Conditions

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Fistula Pancreatic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

prospective, randomized, blinded clinical superiority trial
Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors
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

Study Groups

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Stent

Placement of biodegradable stent intraoperatively.

Group Type ACTIVE_COMPARATOR

Fast Degradable, Biodegradable ARCHEMEDES stent

Intervention Type PROCEDURE

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

No stent

Control group. No placement of stent.

Group Type NO_INTERVENTION

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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rigshospitalet, Denmark

OTHER

Sponsor Role lead

Responsible Party

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Waqas Farooqui

Generel Surgeon

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Rigshospitalet

Copenhagen, Capitol, Denmark

Site Status

Countries

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Denmark

Other Identifiers

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Stent-trial

Identifier Type: -

Identifier Source: org_study_id

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