Percutaneous Transhepatic Cholangiography Versus Endoscopic Ultrasound Guided Biliary Drainage

NCT01686425 | Unknown

• 1 other identifier: ML8383
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Malignant Biliary Obstruction

Keywords

Cholestasis; Malignancy; ERCP; PTC; EUS-BD

Outcome Measures

Primary Outcomes (1)

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

  \- 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

  72 hours

Secondary Outcomes (1)

• Major complications including bile leak, bleeding, sepsis or death

  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

Study Arms (2)

Percutaneous Transhepatic cholangiography

ACTIVE COMPARATOR

Procedure: Percutaneous transhepatic cholangiography vs. endoscopic biliary drainage

Endoscopic Ultrasound guided biliary drainage

ACTIVE COMPARATOR

Procedure: Percutaneous transhepatic cholangiography vs. endoscopic biliary drainage

Interventions

Percutaneous transhepatic cholangiography vs. endoscopic biliary drainage PROCEDURE

Percutaneous transhepatic cholangiography biliary drainage is compared tot endoscopic biliary drainage in the management of malignant biliary obstruction not amenable to ERCP

Endoscopic Ultrasound guided biliary drainage; Percutaneous Transhepatic cholangiography

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• Resectable biliary tract malignancy with curative intent

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

UZ Leuven

Leuven, 3000, Belgium

RECRUITING

MeSH Terms

Conditions

Cholestasis; Neoplasms

Condition Hierarchy (Ancestors)

Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases

Study Officials

• Schalk van der Merwe, MD, PhD

  UZ Leuven

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Schalk van der Merwe, MD, PhD

CONTACT

+32 16 34 42 99; schalk.vandermerwe@uzleuven.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2012
• First Posted: September 18, 2012
• Study Start: July 1, 2012
• Primary Completion: July 1, 2014
• Study Completion: December 1, 2014
• Last Updated: June 13, 2013

Record last verified: 2013-06

Locations

BE (1)