Perihilar Cholangiocarcinoma
Conditions
Keywords
Liver transplantation
Brief summary
LITALHICA is a prospective non-randomized study aimed at exploring the outcome of liver transplantation in selected patients with unresectable perihilar cholangiocarcinoma (pCCA) after treatment with standard of care chemotherapy, in terms of overall survival and quality of life. Additionally, the study aims to identify pre-transplant biological markers and clinical factors that can stratify patients with the best post-transplant prognosis. Finally, the study aims to investigate the role of preoperative PET-MRI, especially in relation to lymph node locations, by correlating the results with histological examination after hilar lymphadenectomy.
Interventions
PROCEDURELiver transplantation
Patients will undergo liver transplantation according to the standard procedures of the institutional Center's protocol (cadaveric or living donor transplantation, whole or partial liver). Liver transplantation is preceded by an exploratory laparotomy with clinical evaluation and frozen section examination of lymph nodes in the hepatoduodenal ligament and along the common hepatic artery/celiac axis.
Sponsors
Azienda Sanitaria Ospedaliera
Istituto Oncologico Veneto IRCCS
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of pCCA (transcatheter biopsy or brush cytology, CA 19-9 \> 100 mg/mL and/or a mass on cross-sectional imaging with a malignant appearing stricture on cholangiography, or biliary ploidy with a malignant appearing stricture on cholangiography) * Unresectable tumor above cystic duct (pancreatoduodenectomy for microscopic involvement of CBD) or resectable pCCA arising in PSC * Absence of major vascular invasion, extrahepatic disease, or involvement of regional lymph nodes * No extrahepatic metastatic disease * Radial tumor diameter ≤3 cm * At least six months between first diagnosis of pCCA and date of inclusion * At least six months of SOC chemotherapy, achieving disease stability or partial response
Exclusion criteria
* Uncontrollable infection * Prior radiotherapy or chemotherapy * Prior biliary surgical resection or attempted surgical resection * Diameter of tumor \>3cm * Presence of intra-hepatic metastases or iCCA * Present or past evidence of extrahepatic metastatic disease * Transperitoneal biopsy (including percutaneous ecography-guided FNA) * Prior neoplasms, except those treated curatively for more than 5 years without recurrence * Substance abuse and medical, psychological, or social conditions that may interfere with the patient's participation in the study * Pregnant or breastfeeding women * Medical-surgical contraindications for liver transplantation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) | 3 and 5 years | Survival from time of transplantation to time of death or last follow up |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival comparison with chemotherapy alone | 3 years | Comparison of 3-year survival between patients enrolled in the LITALHICA study and survival of a population balanced for prognostic factors and disease characteristics from the database of the Veneto Oncological Institute (IOV) |
| Progression-Free Survival (PFS) | 3 and 5 years | Survival from time of transplantation to time of death or first evidence of progression of disease |
| Overall survival from the time of recurrence | 5 years | Survival from time of recurrence to time of death or last follow up |
| Progression-free survival comparison with chemotherapy alone | 3 years | Comparison of 3-year progression-free survival between patients enrolled in the LITALHICA study and progression-free survival of a population balanced for prognostic factors and disease characteristics from the database of the Veneto Oncological Institute (IOV) |
| Biological markers | 5 years | Correlation of overall survival and recurrence with tissue and circulating biological markers (immunohistochemistry, proteomics, circulating tumor cells, circulating tumor DNA, new molecular markers) |
| Morbidity | 90 days | Morbidity at 90 days (according to Clavien-Dindo and Comprehensive Complication Index, CCI) |
| Cancer-related mortality | 3 and 5 years | Risk of mortality with sole relation to death by tumor progression |
| Drop out | 5 years | Percentage of patients who do not complete the procedure (drop-out) stratified by cause |
| Concordance of surgical and PET/MRI staging | Perioperative | Asses if lymph nodes described as suspicious at the preoperative PET-MRI confirm to be pathological at the histological evaluation after lymphadenectomy of the hepatic hilum and exploratory laparotomy |
| Quality of life assessed using EORTC QLQ-C30 | 5 years | Quality of life assessed using EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer QLQ Core Questionnaire) 30 items questionnaire (scale 1-4 or 1-7, 1 being the lowest and 4 or 7 the highest, accordingly) |
| Quality of life assessed using FACT-Hep questionnaire | 5 years | Quality of life assessed using FACT-Hep questionnaire (Functional Assessment of Cancer Therapy - Hepatobiliary) questionnaire about quality of life in the last 7 days (scale 0-4, 0 being the lowest and 4 the highest) |
Countries
Italy
Contacts
CONTACTEnrico Gringeri, Prof.
PRINCIPAL_INVESTIGATOREnrico Gringeri, Prof.
Azienda Ospedale Università di Padova
Outcome results
None listed