Relieving the Bile Ducts Prior to Pancreatoduodenectomy

NCT ID: NCT05434520

Last Updated: 2022-06-28

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

Total Enrollment

722 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-01

Study Completion Date

2022-03-01

Brief Summary

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The aim of this study was to assess the risk and complications after preoperative drainage of biliary obstruction in patients who underwent pancreatoduodenectomy.

A retrospective cohort study of all patients who underwent pancreatoduodenectomy from January 1st, 2015 to September 30th, 2021. Patients who had preoperative bile duct drainage were compared to patients without intervention. Type of interventions, complications and outcome after surgery were compared using univariate and multivariate analysis.

Detailed Description

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Obstructive jaundice is a common problem in pancreatic and periampullary tumors, but preoperative biliary drainage in patients with hyperbilirubinemia is still controversial. The aim of this retrospective cohort study was to assess the risk and complications after preoperative drainage of biliary obstruction in patients who underwent pancreatoduodenectomy.

A retrospective cohort study of all patients who underwent pancreatoduodenectomy from January 1st, 2015 to September 30th, 2021.

Conditions

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Pancreas Cancer Surgery-Complications Biliary Fistula

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Preoperative biliary drainage

Patients who had undergone preoperative biliary drainage (ERC og PTC) prior to pancreatoduodenectomy

Preoperative biliary drainage (ERC og PTC-aided)

Intervention Type PROCEDURE

Placement of biliary stent (plastic, covered SEMS, uncovered SEMS) endoscopic by ERC or placement of plastic catheter by PTC

No preoperative biliary drainage

Patients who had not undergone preoperative biliary drainage (ERC og PTC) prior to pancreatoduodenectomy

No interventions assigned to this group

Interventions

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Preoperative biliary drainage (ERC og PTC-aided)

Placement of biliary stent (plastic, covered SEMS, uncovered SEMS) endoscopic by ERC or placement of plastic catheter by PTC

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* All patients who had undergone pancreatoduodenectomy

Exclusion Criteria

* None
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

Principal Investigator

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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PDPTC1

Identifier Type: -

Identifier Source: org_study_id

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