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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT01549795 |
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Date of registration:
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07/03/2012 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Liver Transplantation for Hilar Cholangiocarcinoma in Association With Neoadjuvant Radio- and Chemo-therapy
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Scientific title:
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Trapianto di Fegato Per Colangiocarcinoma (CCA) Ilare in Associazione a Radio e Chemioterapia Neoadiuvante |
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Date of first enrolment:
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January 2012 |
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Target sample size:
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33 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01549795 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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N/A
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Countries of recruitment
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Italy
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Contacts
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Name:
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Umberto Cillo, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Azienda Ospedaliera di Padova |
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Name:
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Umberto Cillo, MD |
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Address:
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Telephone:
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+390498218547 |
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Email:
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cillo@unipd.it |
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Affiliation:
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Name:
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Umberto Cillo, MD |
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Address:
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Telephone:
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+390498218547 |
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Email:
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cillo@unipd.it |
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Affiliation:
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Name:
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Enrico Gringeri, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Azienda Ospedaliera di Padova |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Older than 18 years
- Male or female
- Diagnosis of Cholangiocarcinoma using:
- PTBD biopsy or Brushing cytology
- Ca 19-9>100mg/ml and/or liver mass at CT or MRI with malignant stenosis apperance at
Cholangiography,
- Non resectable tumour araising above the cystic duct
- Absence of intra and extra hepatic metastasis
- ECOG score(Eastern Cooperative Oncology Group) 0
- ASA score (American Society of Anesthesiologists) = 3
- Ability to understand and willingness to sign the written informed consent form (ICF)
Exclusion Criteria:
- Intrahepatic Cholangiocarcinoma
- Non controlled infection
- Previous radio or chemotherapy
- Previsous bile duct resection or attempt to resection
- Intra and/or extrahepatic metastasis
- Preivious malignant neoplasm (within 5 years)
- Execution of trans peritoneal biopsy
- Tumour diameter more than 3 cm
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Hilar Cholangiocarcinoma
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Primary Sclerosing Cholangitis
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Intervention(s)
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Radiation: 45 Gy external radiations
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Procedure: Pre liver transplantation laparoscopic hand assisted staging
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Procedure: Liver transplantation
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Drug: Capecitabine
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Radiation: Endoluminal bile duct Brachytherapy
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Primary Outcome(s)
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Time to recurrence after liver transplant
[Time Frame: 24 months]
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Percentage of patients free of disease at 24 months post-transplant
[Time Frame: 24 months]
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Secondary Outcome(s)
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Progression disease free survival
[Time Frame: 24 months]
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Overall 2 years survival after liver transplantation
[Time Frame: 24 months]
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Complication rate due to radiotherapy (Hepatic artery thrombosis and Portal vein thrombosis)
[Time Frame: 24 months]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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