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Liver Transplantation for Hilar Cholangiocarcinoma in Association With Neoadjuvant Radio- and Chemo-therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01549795
Recruitment Status : Unknown
Verified July 2012 by Prof. Umberto Cillo, Azienda Ospedaliera di Padova.
Recruitment status was:  Recruiting
First Posted : March 9, 2012
Last Update Posted : July 18, 2012
Information provided by (Responsible Party):
Prof. Umberto Cillo, Azienda Ospedaliera di Padova

Brief Summary:

Single-arm pilot clinical trial. Patients with non operable CC associated with PSC will be subjected to liver transplantation after a neoadjuvant multimodal therapy protocol.

Cholangiocarcinoma (CC) accounts for 3% of all gastrointestinal cancers; it is more frequent in patients with primary sclerosing cholangitis (PSC), who carry an 8%-12% risk of developing this type of neoplasm. Only a minority of patients are suitable for resection partly because of the anatomic position of the tumor (which often arises from the bile duct bifurcation) and partly because of the frequently coexisting liver disease. In fact, CC is currently considered a major contraindication to liver transplantation (OLT) at the majority of centers, given a 5-year survival rate of 0%-35%.

New strategies have been developed for the treatment of this kind of cancer arising in PSC. The Nebraska University group showed a 1 and 3 years survival of 55 and 45 % combining a neoadjuvant intra bile duct barchytherapy and 5-FU based chemotherapy with liver transplantation. University of Pittsburg proposed also a neoadjuvant protocol prior to liver transplantation based on systemic chemotherapy and external radiotherapy reporting a 53% 5 years survival. More convincing results come from the Mayo Clinic. An accurate selection of patients and a proper neoadjuvant multimodal therapy (chemotherapy, external radiotherapy and intraluminal bile duct brachytherapy) lead to a 80% 5 years survival after liver transplantation.

Condition or disease Intervention/treatment Phase
Hilar Cholangiocarcinoma Primary Sclerosing Cholangitis Procedure: Liver transplantation Radiation: 45 Gy external radiations Radiation: Endoluminal bile duct Brachytherapy Drug: Capecitabine Procedure: Pre liver transplantation laparoscopic hand assisted staging Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 33 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Trapianto di Fegato Per Colangiocarcinoma (CCA) Ilare in Associazione a Radio e Chemioterapia Neoadiuvante
Study Start Date : January 2012
Estimated Primary Completion Date : July 2013

Intervention Details:
  • Procedure: Liver transplantation
    Liver transplantation using classic technique and avoiding proximal ilum dissection. The donor hepatic artery will be anastomosed to a jump graft connected to the Aorta. In case of positive margin of the bile duct at a frozen section analysis the liver transplant will be performed after an adjunctive pancreatodudodenctomy
  • Radiation: 45 Gy external radiations
    45 Gy in 30 fractions, 1,5 Gy twice a day) and 5-FU iv infusion- 3 week treatment
  • Radiation: Endoluminal bile duct Brachytherapy
    Brachytherapy (20 Gy a 1 cm in 20-25h) - administered 2 weeks after radiotherapy completion
  • Drug: Capecitabine
    Capecitabine - administered till liver transplantation
  • Procedure: Pre liver transplantation laparoscopic hand assisted staging
    Pre liver transplantation laparoscopic hand assisted staging for sampling hepatic artery lymph nodes and assessing peritoneal disease.

Primary Outcome Measures :
  1. Percentage of patients free of disease at 24 months post-transplant [ Time Frame: 24 months ]
  2. Time to recurrence after liver transplant [ Time Frame: 24 months ]

Secondary Outcome Measures :
  1. Progression disease free survival [ Time Frame: 24 months ]
  2. Overall 2 years survival after liver transplantation [ Time Frame: 24 months ]
  3. Complication rate due to radiotherapy (Hepatic artery thrombosis and Portal vein thrombosis) [ Time Frame: 24 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01549795

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Contact: Umberto Cillo, MD +390498218547
Contact: Enrico Gringeri, MD +390498218547

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Azienda Ospedaliera di Padova Recruiting
Padova, Italy, 35100
Contact: Umberto Cillo, MD    +390498218547   
Contact: Enrico Gringeri, MD    +390498218547   
Principal Investigator: Umberto Cillo, MD         
Sub-Investigator: Enrico Gringeri, MD         
Sub-Investigator: Domenico Bassi, MD         
Sub-Investigator: Giacomo Zanus, MD         
Sub-Investigator: Daniele Neri, MD         
Sub-Investigator: Francesco D'Amico, MD         
Sub-Investigator: Alessandro Vitale, MD         
Sponsors and Collaborators
Azienda Ospedaliera di Padova
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Study Chair: Umberto Cillo, MD Azienda Ospedaliera di Padova
Principal Investigator: Enrico Gringeri, MD Azienda Ospedaliera di Padova
Additional Information:
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Responsible Party: Prof. Umberto Cillo, Director of the Hepatobiliary Surgery and Liver Transplantation Unit, Azienda Ospedaliera di Padova Identifier: NCT01549795    
Other Study ID Numbers: 2372P
First Posted: March 9, 2012    Key Record Dates
Last Update Posted: July 18, 2012
Last Verified: July 2012
Keywords provided by Prof. Umberto Cillo, Azienda Ospedaliera di Padova:
Liver transplantation
Neoadjuvant radio- chemo-therapy
Additional relevant MeSH terms:
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Klatskin Tumor
Cholangitis, Sclerosing
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases
Liver Extracts
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents