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

Trapianto di Fegato Per Colangiocarcinoma (CCA) Ilare in Associazione a Radio e Chemioterapia Neoadiuvante

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01549795
Enrollment
33
Registered
2012-03-09
Start date
2012-01-31
Completion date
Unknown
Last updated
2012-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hilar Cholangiocarcinoma, Primary Sclerosing Cholangitis

Keywords

Liver transplantation, Neoadjuvant radio- chemo-therapy

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.

Interventions

PROCEDURELiver 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

RADIATION45 Gy external radiations

45 Gy in 30 fractions, 1,5 Gy twice a day) and 5-FU iv infusion- 3 week treatment

RADIATIONEndoluminal bile duct Brachytherapy

Brachytherapy (20 Gy a 1 cm in 20-25h) - administered 2 weeks after radiotherapy completion

DRUGCapecitabine

Capecitabine - administered till liver transplantation

PROCEDUREPre liver transplantation laparoscopic hand assisted staging

Pre liver transplantation laparoscopic hand assisted staging for sampling hepatic artery lymph nodes and assessing peritoneal disease.

Sponsors

Azienda Ospedaliera di Padova
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
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

Design outcomes

Primary

MeasureTime frame
Percentage of patients free of disease at 24 months post-transplant24 months
Time to recurrence after liver transplant24 months

Secondary

MeasureTime frame
Complication rate due to radiotherapy (Hepatic artery thrombosis and Portal vein thrombosis)24 months
Progression disease free survival24 months
Overall 2 years survival after liver transplantation24 months

Countries

Italy

Contacts

Primary ContactUmberto Cillo, MD
cillo@unipd.it+390498218547
Backup ContactEnrico Gringeri, MD
enrico.gringeri@unipd.it+390498218547

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026