Ultrasound-guided Percutaneous Biliary Drainage With Primary Metal Implantation by Endoscopic Luminal Guidance

May 17, 2018 updated by: Daniel Schmitz, Theresienkrankenhaus und St. Hedwig-Klinik GmbH

Ultrasound-guided Percutaneous Biliary Drainage With Primary Metal Implantation by Endoscopic Luminal Guidance in Patients With Malignant Extrahepatic Bile Duct Obstruction

In a recently published meta-analysis (Sharaiha, Gastrointestinal Endoscopy, 2017), it is reported that percutaneous transhepatic biliary drainage (PTBD) is less clinical successful, causes more adverse events and needs more re-interventions than endoscopic ultrasound guided biliary drainage (EUBD) in patients with malignant, extrahepatic bile duct obstruction. The conclusion was, that EUBD should be prefered in this clinical setting in future.

An improved technique of PTBD may provide better results for coming comparative studies.

The investigators of this retrospective study therefore analyzed all PTBDs that were performed in a period of nine years in a tertiary referral hospital. In this cohort, the analysis focused on PTBDs with primary metal stent implantation by endoscopic luminal guidance.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

When Endoscopic Retrograde Cholangiopancreaticography (ERCP) is not successful or is not possible to be performed due to anatomical reasons (altered anatomy after abdominal surgery) in patients with malignant extrahepatic bile duct obstruction, an alternative method is necessary for biliary drainage. In a recently published meta-analysis (Sharaiha, Gastrointestinal Endoscopy, 2017), it is reported that percutaneous transhepatic biliary drainage (PTBD) is less clinical successful, causes more adverse events and needs more re-interventions than endoscopic ultrasound guided biliary drainage (EUBD) in patients with malignant, extrahepatic bile duct obstruction. The conclusion was, that EUBD should be prefered in this clinical setting in future.

An improved technique of PTBD may provide better results for coming comparative studies.

The investigators of this retrospective study therefore analyzed all PTBDs that were performed in a period of nine years in a tertiary referral hospital. In this cohort, the analysis focused on PTBDs with primary metal stent implantation by endoscopic luminal guidance considering technical and clinical success, access route, procedure time, fluoroscopic time, radiation exposure, adverse events and survival probability in an observation time of six months.

Study Type

Observational

Enrollment (Actual)

66

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Mannheim, Germany, 68165
        • Tertiary referral hospital: Theresienkrankenhaus und St. Hedwig Hospital, Academic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

All patients which met the mentioned inclusion and exclusion criteria were enrolled in the study consecutively

Description

Inclusion Criteria:

  • age ≥ 18 years
  • not curatively operable, malignant disease with proximal or distal bile duct obstruction
  • elevated serum bilirubin level and/or elevated alkaline phosphatase to at least a twofold degree
  • histologically verified diagnosis
  • at least one cross-sectional imaging method like computed tomography or magnetic resonance imaging of the abdomen has to be performed

Exclusion Criteria:

  • uncorrectable coagulopathy (prothrombin time < 50%, platelet count < 50.000/nl, partial thromboplastin time (PTT) > 50 sec.
  • advanced tumor disease with limited life expectancy (< 1 month)
  • diffuse liver metastasis
  • pregnant or breast feeding women
  • potentially curatively, operable, malignant bile duct obstruction
  • diseases which can be cured by chemotherapy (for example aggressive non Hodgkin-lymphoma).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
technical success
Time Frame: 1 minute after injection of a radiocontrast agent into the expanded metal stent
metal stent was implanted successfully bridging the tumor stenosis
1 minute after injection of a radiocontrast agent into the expanded metal stent

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
clinical success
Time Frame: 7 days
decrease of Serum Bilirubin level >50%
7 days
adverse events
Time Frame: Up to 30 days after the intervention
the report of any adverse events after the procedure, grading of adverse events according to the ASGE lexicon's severity grading system
Up to 30 days after the intervention
re-interventions
Time Frame: 6 months
Number of re-interventions (ERCP or PTCD) that are necessary after successful PTBD (for example due to stent migration or stent occlusion)
6 months
overall survival
Time Frame: 2 years
death in the follow up afterperformed PTBD
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Theresienkrankenhaus und St. Hedwig-Klinik GmbH

Investigators

  • Study Director: Jochen Rudi, Prof.Dr.med., Theresienkrankenhaus und St.Hedwigsklinik GmbH

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2008

Primary Completion (Actual)

October 30, 2017

Study Completion (Actual)

December 31, 2017

Study Registration Dates

First Submitted

April 23, 2018

First Submitted That Met QC Criteria

May 17, 2018

First Posted (Actual)

May 30, 2018

Study Record Updates

Last Update Posted (Actual)

May 30, 2018

Last Update Submitted That Met QC Criteria

May 17, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PTBD retro 001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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