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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01960712
Enrollment
40
Registered
2013-10-11
Start date
2008-11-30
Completion date
2017-05-31
Last updated
2020-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bile Leakage

Brief summary

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

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.

Interventions

DEVICETranspapillary plastic stent (7-10 Fr)

Duodenoscopy plus transpapillary bile cannulation plus stent insertion.

Sponsors

Jansson, Anders, M.D.
CollaboratorINDIV
Karolinska University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

* Liver resection including at least two liver segments.

Exclusion criteria

* Hepatobiliary digestive anastomosis.

Design outcomes

Primary

MeasureTime frame
Number of days of bile leakage from the abdominal cavityFrom intervention until day discharge from hospital

Secondary

MeasureTime frame
General complications rates. Postoperative hospital stayFrom intervention until day of discharge from hospital

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026