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: 9.1 Level: LLT Classification code 10062883 MedDRA version: 9.1 Level: LLT Classification code 10004665 MedDRA version: 9.1 Level: LLT Classification code 10061008 MedDRA version: 9.1 Level: LLT Classificat
Conditions
Interventions
Trade Name: BILISCOPIN
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Iotroxic acid
Concentration unit: g gram(s)
Concentration type: equal
Concentration number: 10.5-
Sponsors
AZIENDA SANITARIA OSPEDALIERA "S. GIOVANNI BATTISTA DI TORINO"
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the diagnostic accuracy of the CT cholangiography with Biliscopin in patients with malignancies of the bile ducts or with postoperative biliary complications by estimating sensitivity and specificity rates; and to compare the diagnostic characteristics of the CT cholangiography with Biliscopin with those of MRI cholangiography and/or percutaneous, transhepatic cholangiography.;Secondary Objective: To evaluate the inter-observer agreement in defining the biliary tree anatomy and the tumor extension on CT cholangiography images and to evaluate the tolerability of such an exam by clinically monitoring all patients since Biliscopin has been infused until 30 minuts after the end of the CT exam. Any adverse events during this time period will be recorded and clinically or pharmacologically treated.;Primary end point(s): To evaluate the CT cholangiography with Biliscopin?s diagnostic accuracy in identifying the biliary anatomy, the site and extent of the biliary stenosis/injury in patients with malignancies of the bile ducts or with postoperative biliary complications and to compare its diagnostic characteristics with those of MRI cholangiography and/or percutaneous transhepatic cholangiography. The aim of the study is to assess whether CT cholangiography with Biliscopin is at least equal to MRI cholangiography and/or percutaneous transhepatic cholangiography to propose it as a unique preoperative staging exam. Such a change in the preoperative work-up, i.e. 1 exam versus at least 2, will certainly benefit the patients and reduce the costs. | — |
Countries
Italy
Outcome results
None listed