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


N/A
18 Years
65 Years
Open (Enrolling)
Both
Hilar Cholangiocarcinoma, Primary Sclerosing Cholangitis

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Percentage of patients free of disease at 24 months post-transplant

Outcome Time Frame:

24 months

Safety Issue:

No

Principal Investigator

Umberto Cillo, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Azienda Ospedaliera di Padova

Authority:

Italy: Ethics Committee

Study ID:

2372P

NCT ID:

NCT01549795

Start Date:

January 2012

Completion Date:

Related Keywords:

  • Hilar Cholangiocarcinoma
  • Primary Sclerosing Cholangitis
  • Liver transplantation
  • Neoadjuvant radio- chemo-therapy
  • Cholangitis
  • Cholangitis, Sclerosing
  • Cholangiocarcinoma
  • Klatskin's Tumor

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