E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10062883 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10004665 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10061008 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10004647 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
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. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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. |
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E.4 | Principal 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 |
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E.5 End points |
E.5.1 | Primary end point(s) |
To evaluate the CT cholangiography with Biliscopins 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. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
ALTRE METODICHE DIAGNOSTICHE (CPRM, CPT) |
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E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 0 |