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

Sponsor
Theresienkrankenhaus und St. Hedwig-Klinik GmbH (Other)
Overall Status
Completed
CT.gov ID
NCT03541590
Collaborator
(none)
66
Enrollment
1
Location
109
Actual Duration (Months)
0.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Percutaneous transhepatic biliary drainage

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 Design

Study Type:
Observational
Actual Enrollment :
66 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Ultrasound-guided Percutaneous Biliary Drainage With Primary Metal Implantation by Endoscopic Luminal Guidance in Patients With Malignant Extrahepatic Bile Duct Obstruction
Actual Study Start Date :
Dec 1, 2008
Actual Primary Completion Date :
Oct 30, 2017
Actual Study Completion Date :
Dec 31, 2017

Outcome Measures

Primary Outcome Measures

  1. technical success [1 minute after injection of a radiocontrast agent into the expanded metal stent]

    metal stent was implanted successfully bridging the tumor stenosis

Secondary Outcome Measures

  1. clinical success [7 days]

    decrease of Serum Bilirubin level >50%

  2. adverse events [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

  3. re-interventions [6 months]

    Number of re-interventions (ERCP or PTCD) that are necessary after successful PTBD (for example due to stent migration or stent occlusion)

  4. overall survival [2 years]

    death in the follow up afterperformed PTBD

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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).

Contacts and Locations

Locations

Site City State Country Postal Code
1 Tertiary referral hospital: Theresienkrankenhaus und St. Hedwig Hospital, Academic Mannheim Germany 68165

Sponsors and Collaborators

  • Theresienkrankenhaus und St. Hedwig-Klinik GmbH

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Daniel Schmitz, Principal investigator, Theresienkrankenhaus und St. Hedwig-Klinik GmbH
ClinicalTrials.gov Identifier:
NCT03541590
Other Study ID Numbers:
  • PTBD retro 001
First Posted:
May 30, 2018
Last Update Posted:
May 30, 2018
Last Verified:
May 1, 2018
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Daniel Schmitz, Principal investigator, Theresienkrankenhaus und St. Hedwig-Klinik GmbH
percutaneous biliary drainage
Additional relevant MeSH terms:
Cholestasis
Cholestasis, Extrahepatic

Study Results

No Results Posted as of May 30, 2018