Post-operative Drainage After Pancreaticoduodenectomy

NCT ID: NCT05270564

Last Updated: 2022-03-08

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-01

Study Completion Date

2025-03-31

Brief Summary

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The study compares regular use of surgical drains and no use of surgical drains in patients subjected to pancreaticoduodenectomy with expected low to intermediate risk for post operative pancreatic fistula.

Detailed Description

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Conditions

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Pancreatic Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized controlled study
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Drain

Surgical drains used as routine

Group Type ACTIVE_COMPARATOR

Drain

Intervention Type PROCEDURE

Surgical drains are placed as a standard of care (control arm) or not (experimental arm)

No drain

No surgical drain used

Group Type EXPERIMENTAL

No drain

Intervention Type PROCEDURE

Surgical drains are placed as a standard of care (control arm) or not (experimental arm)

Interventions

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Drain

Surgical drains are placed as a standard of care (control arm) or not (experimental arm)

Intervention Type PROCEDURE

No drain

Surgical drains are placed as a standard of care (control arm) or not (experimental arm)

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients undergoing pancreaticoduodenectomy of both sexes
* Patients with predicted risk score of 10 or less of pancreatic fistula
* Written informed consent
* Expected survival time \> 6 months

Exclusion Criteria

* Patients with predicted high risk of fistula with a risk score above 10
* Patients with intraabdominal abscess or infection
* ASA score \> 3
* Pregnancy
* Expected lack of compliance
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Lund University

OTHER

Sponsor Role collaborator

Linkoeping University

OTHER_GOV

Sponsor Role lead

Responsible Party

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Bergthor Björnsson

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bergthor Björnsson

Role: PRINCIPAL_INVESTIGATOR

Linkoeping University

Locations

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Linkoping University Hospital

Linköping, , Sweden

Site Status RECRUITING

Skanes University Hospital

Lund, , Sweden

Site Status RECRUITING

Countries

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Sweden

Central Contacts

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Bergthor Björnsson

Role: CONTACT

+46703766890

Facility Contacts

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Bergthor Björnsson

Role: primary

+46703766890

Bobby Tingstedt

Role: primary

Other Identifiers

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Drain_1

Identifier Type: -

Identifier Source: org_study_id

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