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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by Universitaire Ziekenhuizen Leuven
Sponsor:
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:
NCT01686425
First received: July 10, 2012
Last updated: June 12, 2013
Last verified: June 2013
  Purpose

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 Intervention
Malignant Biliary Obstruction
Procedure: Percutaneous transhepatic cholangiography vs. endoscopic biliary drainage

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Universitaire Ziekenhuizen Leuven:

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

    - 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:
  • 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 ] [ Designated as safety issue: Yes ]

    - Secondary endpoints

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


Estimated Enrollment: 60
Study Start Date: July 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT01686425     History of Changes
Other Study ID Numbers: ML8383
Study First Received: July 10, 2012
Last Updated: June 12, 2013
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

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

ClinicalTrials.gov processed this record on November 27, 2014