Evaluation of the diagnostic efficacy of the CT cholangiography performed by administering an intra-venous contrast medium with biliary excretion (Biliscopin) in patients with malignancies of the bile ducts or with postoperative biliary complications. - ND

• Conditions: Patients with obstructive jaundice due to a biliary malignancy (Klatskin tumor, tumor of the middle or distal bile ducts or Galbladder tumors)Patients with post-cholecistectomy iatrogenic lesions of the bile ducts or with biliary complications after liver transplantation.; MedDRA version: 9.1Level: LLTClassification code 10062883; MedDRA version: 9.1Level: LLTClassification code 10004665; MedDRA version: 9.1Level: LLTClassification code 10061008; MedDRA version: 9.1Level: LLTClassification code 10004647

• Registration Number: EUCTR2008-004762-83-IT
• Lead Sponsor: AZIENDA SANITARIA OSPEDALIERA S. GIOVANNI BATTISTA DI TORINO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09-30
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

- Patients with obstructive jaundice due to a biliary malignancy (Klatskin tumor, tumor of the middle or distal bile ducts or Galbladder tumors)
- Patients with post-cholecistectomy iatrogenic lesions of the bile ducts or with biliary complications after liver transplantation.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Contraindication to intravenous infusion of contrast medium (such as cardiac or pulmunary insufficiency, hepatic feilure and hypersensitivity to iodine contrast medium; hypertyroidism, pheocromocitoma and monoclonal gammopathy)
- patient with endoscopic or percutaneus biliary drainage

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified