The Role of Transpapillary Stenting in the Treatment of Bile Leakage After Liver Transection.

NCT ID: NCT01960712

Last Updated: 2020-10-06

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

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2017-05-31

Brief Summary

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Bile leakage after liver transection is treated by external drainage. The question addressed is whether downstream control by transpapillary stent insertion into distal bile duct can enhance healing.

Detailed Description

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All patients who present with clinically significant bile leakage after liver resection at postoperative day two or longer are offered the opportunity to become randomized to either continuous external drainage or the addition of transpapillary stent.

Conditions

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Bile Leakage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Continued external drainage

Continued external drainage alone.

Group Type NO_INTERVENTION

No interventions assigned to this group

Continued external drainage + transpapillary stent

External drainage + transpapillary plastic stent (7-10 Fr).

Group Type ACTIVE_COMPARATOR

Transpapillary plastic stent (7-10 Fr)

Intervention Type DEVICE

Duodenoscopy plus transpapillary bile cannulation plus stent insertion.

Interventions

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Transpapillary plastic stent (7-10 Fr)

Duodenoscopy plus transpapillary bile cannulation plus stent insertion.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Liver resection including at least two liver segments.

Exclusion Criteria

* Hepatobiliary digestive anastomosis.
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jansson, Anders, M.D.

INDIV

Sponsor Role collaborator

Karolinska University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Lars Lundell

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lars Lundell, Professor

Role: PRINCIPAL_INVESTIGATOR

Karolinska University Hospital

Locations

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Karolinska University Hospital

Stockholm, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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2006/1142-31/3

Identifier Type: OTHER

Identifier Source: secondary_id

2006/1142-31/3

Identifier Type: -

Identifier Source: org_study_id

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