Evaluation of the bilo-enteric anastomoses with contrast-enhanced MR-cholangiopancreatography (MRCP) with PRIMOVIST (Gd-EOB-DTPA-enhanced MRCP): comparison with conventional T2-weighted MRCP. - ND

Conditions: Patients with clinical-echographical suspect of biliary pathology and pre-existing bilo-enteric anastomoses.
MedDRA version: 9.1Level: HLTClassification code 10019808Term: Hepatobiliary imaging procedures

Registration Number: EUCTR2009-010861-21-IT

Lead Sponsor: AZIENDA OSPEDALIERA PISANA

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

1. Adult (18 years and older) patients (men or women of any ethnic group). 2. Patients with clinical-echographical suspect of biliary pathology. 3. Patients with pre-existing bilo-enteric anastomoses. 4. Patients willing and able to undergo all study procedures. 5. Women in fertile age that use contraceptives. 6. Patients who have signed the written informed consent.
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

1. Pregnant or lactating women. 2. Patients with less than 3 months life expectation. 3. Patients presenting with contraindication to MR. 4. Patients with cardiac pacemakers and ferromagnetic implants 5. Patients taking class III antiarrhythmic and rifampicin 6. Patients with uncorrected hypokalemia or hypopotassemia 7. History of allergic disorder (of any severity) or allergic reaction to MR contrast media. 8.Patients with history of bronchial asthma and severe cardiovascular problem 9. Uncooperative, in the investigator?s opinion. 10. Severe renal impairment (GFR< 30ml/min /1.73 m2). 11. Severe hepatic impairment. 12. Participating in another clinical trial.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The purpose of this study is to assess the added efficacy of Primovist in MRCP in comparison to the conventional T2-weighted MRCP in depicting the biliary pathology in patients with pre-existing bilo-enteric anastomoses. The reference method is surgery finding, if scheduled, and/or a six-months-lasting clinical-radiological follow-up.;Secondary Objective: The secondary study objective is to monitor the incidence of AE in MR procedure.;Primary end point(s): Concordance rate between experimental procedures and reference standard results on a per patient basis. An exam will be considered concordant with the reference standard if the results in term of diagnostic findings will be exactly the same.

Secondary Outcome Measures