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OpenTrials
Completed

NCT Number: NCT01960712

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

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.

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Key information

Conditions

Bile Leakage

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Karolinska University Hospital

Stockholm, 14186, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Liver resection including at least two liver segments.

Exclusion criteria

  • Hepatobiliary digestive anastomosis.

Treatment and study plan

Transpapillary plastic stent (7-10 Fr)

Device

Duodenoscopy plus transpapillary bile cannulation plus stent insertion.

Primary outcomes

  1. Number of days of bile leakage from the abdominal cavity

    Time frame: From intervention until day discharge from hospital

Secondary outcomes

  1. General complications rates. Postoperative hospital stay

    Time frame: From intervention until day of discharge from hospital

Sponsors and collaborators

Lead sponsor

Karolinska University Hospital

Other

Collaborators

  • Jansson, Anders, M.D.

Registry information

Important dates

Study start
2008
Primary completion
2017
Study completion
2017
First posted
Oct 11, 2013
Registry last updated
Oct 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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