Neoplasms

All Conditions

Digestive System Diseases

Rare Diseases

Cholangiocarcinoma

Klatskin Tumor

Cholangitis

Cholangitis, Sclerosing

Adenocarcinoma

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Bile Duct Diseases

Biliary Tract Diseases

Gastrointestinal Diseases

Bile Duct Cancer

Primary Sclerosing Cholangitis

Antineoplastic Agents

All Drugs and Chemicals

Hematinics

Capecitabine

Fluorouracil

Liver Extracts

Antimetabolites

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

Liver transplantation

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

45 Gy external radiations

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

Endoluminal bile duct Brachytherapy

Capecitabine - administered till liver transplantation

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

Pre liver transplantation laparoscopic hand assisted staging

Umberto Cillo, MD

Enrico Gringeri, MD

Domenico Bassi, MD

Giacomo Zanus, MD

Daniele Neri, MD

Francesco D'Amico, MD

Alessandro Vitale, MD

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.

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

Azienda Ospedaliera di Padova

Director of the Hepatobiliary Surgery and Liver Transplantation Unit

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Liver Transplantation for Hilar Cholangiocarcinoma in Association With Neoadjuvant Radio- and Chemo-therapy	NCT01549795	Hilar Cholangio... Primary Scleros...	Liver transplan... 45 Gy external ... Endoluminal bil... Capecitabine Pre liver trans...	18 Years - 65 Years	Azienda Ospedaliera di Padova
Liver Transplantation for Hilar Cholangiocarcinoma in Association With Neoadjuvant Radio- and Chemo-therapy	NCT01549795	Hilar Cholangio... Primary Scleros...	Liver transplan... 45 Gy external ... Endoluminal bil... Capecitabine Pre liver trans...	18 Years - 65 Years	Azienda Ospedaliera di Padova

Spots Global Cancer Trial Database for 45 gy external radiations