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Percutaneous Transhepatic Cholangiography Versus Endoscopic Ultrasound Guided Biliary Drainage (PETRUS)

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ClinicalTrials.gov Identifier: NCT01686425
Recruitment Status : Unknown
Verified June 2013 by Universitaire Ziekenhuizen Leuven.
Recruitment status was:  Recruiting
First Posted : September 18, 2012
Last Update Posted : June 13, 2013
Sponsor:
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven

Brief Summary:

Patients with obstructive jaundice due to locally advanced/metastatic malignancy with dilated intrahepatic bile ducts will be recruited from the department of Gastroenterology and Hepatology at the University Hospital of Leuven.

This population will have failed ERCP or will be considered when ERCP is not possible due to altered surgical anatomy.

Patients will be randomized to either PTC or EUS guided biliary drainage


Condition or disease Intervention/treatment
Malignant Biliary Obstruction Procedure: Percutaneous transhepatic cholangiography vs. endoscopic biliary drainage

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Percutaneous Transhepatic Cholangiography Versus Endoscopic Ultrasound Guided Biliary Drainage in Advanced Biliary Tract Malignancy That Failed ERCP (PETRUS Study): A Randomized Pilot Study
Study Start Date : July 2012
Estimated Primary Completion Date : July 2014
Estimated Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Percutaneous Transhepatic cholangiography Procedure: Percutaneous transhepatic cholangiography vs. endoscopic biliary drainage
Percutaneous transhepatic cholangiography biliary drainage is compared tot endoscopic biliary drainage in the management of malignant biliary obstruction not amenable to ERCP
Active Comparator: Endoscopic Ultrasound guided biliary drainage Procedure: Percutaneous transhepatic cholangiography vs. endoscopic biliary drainage
Percutaneous transhepatic cholangiography biliary drainage is compared tot endoscopic biliary drainage in the management of malignant biliary obstruction not amenable to ERCP



Primary Outcome Measures :
  1. Pain: Post-procedural pain as measured by visual analogue score (VAS) at 2, 24, and 72 hours following the procedures [ Time Frame: 72 hours ]

    - Primary endpoints

    • Pain: Post-procedural pain as measured by visual analogue score (VAS) at 2, 24, and 72 hours following the procedures
    • Biochemical changes: Bilirubin decrease at 2 and 4 weeks


Secondary Outcome Measures :
  1. Major complications including bile leak, bleeding, sepsis or death [ Time Frame: Participants will be followed for the duration of their hospital stay and for up to 4 weeks. In addition patients will be followed up to death or for a maximum period of 1 year following the procedure ]

    - Secondary endpoints

    • Major complications including bile leak, bleeding, sepsis or death
    • Duration of procedures
    • Length of ICU stay
    • Minor complications



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients older than 18 years presenting with malignant obstructive jaundice
  • Locally advanced primary or metastatic malignancy involving the biliary tract
  • Patients in whom an ERCP have failed or where an ERCP is not possible due to surgically altered anatomy (eg. Post-Whipple).

Exclusion Criteria:

  • Resectable biliary tract malignancy with curative intent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01686425


Contacts
Contact: Schalk van der Merwe, MD, PhD +32 16 34 42 99 schalk.vandermerwe@uzleuven.be

Locations
Belgium
UZ Leuven Recruiting
Leuven, Belgium, 3000
Contact: Schalk van der Merwe, MD, PhD    +32 16 34 42 99    schalk.vandermerwe@uzleuven.be   
Contact: Frederik Nevens, MD, PhD    +32 16 34 42 99    frederik.nevens@uzleuven.be   
Sub-Investigator: Frederik Nevens, MD, PhD         
Sub-Investigator: Werner Van Steenbergen, MD, PhD         
Sub-Investigator: Chris Verslype, MD, PhD         
Sub-Investigator: David Cassiman, MD, PhD         
Sub-Investigator: Wim Laleman, MD, PhD         
Sub-Investigator: Geert Maleux, MD, PhD         
Principal Investigator: Schalk van der Merwe, MD, PhD         
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Investigators
Principal Investigator: Schalk van der Merwe, MD, PhD UZ Leuven

Responsible Party: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT01686425     History of Changes
Other Study ID Numbers: ML8383
First Posted: September 18, 2012    Key Record Dates
Last Update Posted: June 13, 2013
Last Verified: June 2013

Keywords provided by Universitaire Ziekenhuizen Leuven:
Cholestasis
Malignancy
ERCP
PTC
EUS-BD