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

Not Applicable

• Conditions: Hilar Cholangiocarcinoma; Primary Sclerosing Cholangitis

• Registration Number: NCT01549795
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-03-07
• Study First Submitted QC: 2012-03-08
• Study First Posted: 2012-03-09
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-17
• Last Update Posted: 2012-07-18
• Primary Completion: 2013-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 33

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Time to recurrence after liver transplant	24 months
Percentage of patients free of disease at 24 months post-transplant	24 months

Secondary Outcome Measures

Name	Time	Method
Progression disease free survival	24 months
Overall 2 years survival after liver transplantation	24 months
Complication rate due to radiotherapy (Hepatic artery thrombosis and Portal vein thrombosis)	24 months

Trial Locations

Locations (1)

Azienda Ospedaliera di Padova; 🇮🇹 Padova, Italy