C24.0
Conditions
Interventions
Group 1: Liver transplantation
Sponsors
Charité - Universitätsmedizin Berlin, Chirurgische Klinik, Campus Charité Mitte | Charité Campus Virchow-Klinikum
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: • Protocol defined diagnosis of perihilarcholangiocarcinoma in patients with primary sclerosing cholangitis (PSC): i.e. histological diagnosis of cholangiocarcinoma (obtained via ERC) or dominant stenosis plus cytological diagnosis of severe dysplasia or two subsequent cytological results of severe dysplasia or carcinoma whereby the second has been obtained after 2 weeks of antibiotic treatment to exclude inflammatory changes • Protocol defined diagnosis of perihilar cholangiocarcinoma in patients without PSC: clinical diagnosis of proximal bile duct cancer based on ERC plus a second method (CT or MRI), cytology is obtained during ERC, but a cytological result of carcinoma or severe dysplasia is not mandatory • tumor not curatively resectable as judged by an experienced hepatobiliary surgeon (> 50 liver resections for perihilar cholangiocarcinoma) • on-line review of defined patient data and acceptance for priority listing by an Eurotransplant expert panel consisting of two experts recruited from the Eurotransplant Liver Allocation Committee; in case of split decision addition of a third expert for definite decision on priority listing with a respective matchMELD. • obligatory diagnostic laparoscopy (including robotic approach) or laparotomy before priority listing (see SOP diagnostic laparoscopy (including robotic approach)/laparotomy, chapter, chapter 7.5.1.4) • age between 18 and 70 years • negative pregnancy test • informed consent before study enrolment (all other procedures are clinical routine procedures in the management of these patients)
Exclusion criteria
Exclusion criteria: • locally very advanced, unresectable tumor infiltrating adjacent other organs, the main trunk of the hepatic artery • a visible tumor mass on CT or MRI scan larger than 3 cm in diameter • highly elevated CA 19-9 levels (> 1000 U/ml) • Decompression of the bile ducts by external drainage (PTCD) • tumors suspicious for gallbladder cancer • known lymph node or distant metastasis (determined mandatory by CT scan/MRI and diagnostic laparoscopy (including robotic approach) or laparotomy, further investigations if deemed necessary, a PET scan is recommended) • patients undergoing multi-organ transplantation or have undergone previous solid organ or bone marrow transplantation • previous photodynamic therapy, radiation, brachytherapy or combinations of these procedures • previous tumor biopsy (except via ERC) systematic lymphadenectomy (except SOP defined diagnostic laparoscopy (including robotic approach/laparotomy), surgical preparation at the region of the hepatoduodenal ligament (except cholecystectomy for other reasons) or previous completed or attempted surgery for hilar cholangiocarcinoma • pregnancy or breastfeeding • patients unwilling to consent to saving and propagation of pseudonymized medical data for study reasons • general contraindications for liver transplantation • subjects who are legally detained in an official institute
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of microscopic tumor clearance (R0) after liver transplantation. The freedom from tumors is documented in the pathological report, which is usually available no later than 7 days after transplantation. | — |
Secondary
| Measure | Time frame |
|---|---|
| • Overall survival after 36 months • Recurrence-free survival after 36 months • Postoperative complication rate (III - V according to Dindo-Clavien) As part of the aftercare, there are 4-weekly visits until month 3 and then every 3 months until 2 years after transplantation. | — |
Countries
Germany
Contacts
Public ContactAndrea Köpke
Charité - Universitätsmedizin Berlin, Chirurgische Klinik, Campus Charité Mitte | Campus Virchow-Klinikum
Outcome results
None listed