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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2012 by Prof. Umberto Cillo, Azienda Ospedaliera di Padova.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
Prof. Umberto Cillo, Azienda Ospedaliera di Padova Identifier:
First received: March 7, 2012
Last updated: July 17, 2012
Last verified: July 2012

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 Intervention
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

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Prof. Umberto Cillo, Azienda Ospedaliera di Padova:

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

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

Estimated Enrollment: 33
Study Start Date: January 2012
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
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.

Ages Eligible for Study:   18 Years to 65 Years   (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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01549795

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

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
Study Chair: Umberto Cillo, MD Azienda Ospedaliera di Padova
Principal Investigator: Enrico Gringeri, MD Azienda Ospedaliera di Padova
  More Information

Additional Information:
Responsible Party: Prof. Umberto Cillo, Director of the Hepatobiliary Surgery and Liver Transplantation Unit, Azienda Ospedaliera di Padova Identifier: NCT01549795     History of Changes
Other Study ID Numbers: 2372P
Study First Received: March 7, 2012
Last Updated: July 17, 2012

Keywords provided by Prof. Umberto Cillo, Azienda Ospedaliera di Padova:
Liver transplantation
Neoadjuvant radio- chemo-therapy

Additional relevant MeSH terms:
Cholangitis, Sclerosing
Klatskin Tumor
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 processed this record on September 21, 2017