Percutaneous Transhepatic Cholangiography Versus Endoscopic Ultrasound Guided Biliary Drainage (PETRUS)
This study is currently recruiting participants.
Verified September 2012 by Universitaire Ziekenhuizen Leuven
Sponsor:
Universitaire Ziekenhuizen Leuven
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:
NCT01686425
First received: July 10, 2012
Last updated: September 25, 2012
Last verified: September 2012
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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
|
Show Detailed Description 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
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: | September 25, 2012 |
| 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 May 16, 2013