Living Donor Liver Transplantation for Intrahepatic Cholangiocarcinoma

NCT06539377 | Not Yet Recruiting

• 1 other identifier: 2024-3430-BO
• Study Type: interventional
• Target: 6
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is supposed to make liver transplantation available for treatment in well selected patients suffering from non-resectable intrahepatic cholangiocarcinoma. Donor organ shortage is currently the main problem for organ transplantation world-wide. Thus, the particular indication "non-resectable intrahepatic cholangiocarcinoma" is currently excluded in terms of transplantation. Given those circumstances, transplantation via living donation might be the best option. This procedure does not reduce the deceased donor organ supply because living donation is the primary treatment option in these patients (not subsidiary).

Conditions

Living Donor Liver Transplantation; Liver Transplantation; Neoadjuvant Therapy

Keywords

intrahepatic cholangiocarcinoma; living donor liver transplantation; neoadjuvant therapy; SIRT

Outcome Measures

Primary Outcomes (1)

• Five year overall survival

  Survival from time of transplantation to time of death or last follow up

  Five years

Secondary Outcomes (2)

• Recurrence-free survival

  Five years

• Donor and Recipient morbidity

  Five years

Study Arms (1)

Living donor liver transplantation

EXPERIMENTAL

The evaluation tests prior the transplantation will be performed following the standard protocol for the evaluation of a waiting list applicants prior liver transplantation. The aim of this procedure is to rule out any significant co-morbidities (e.g. cardiologic diseases, other malignancies) which would preclude liver transplantation. After successful evaluation of the recipient and waiting list registration with Eurotransplant, the AB0-compatible donor will be evaluated as well according to a center-specific protocol. For a local control of the tumor, an additional local-ablative therapy (SIRT) is mandatory.

Procedure: Living donor liver transplantation

Interventions

Living donor liver transplantation PROCEDURE

Liver transplantation from living donor donation (SII/III as left-lateral donation during a "two stage"-procedure or left lobe donation or right lobe donation) in patients with unresectable intrahepatic cholangiocarcinoma.

Living donor liver transplantation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• non-resectable intrahepatic cholangiocarcinoma (either for localization / distribution of the carcinoma or for estimated function of the liver in case of liver fibrosis / cirrhosis)
• biopsy proven grading G1 / G2
• in case of mixed hepatocellular carcinoma / cholangiocarcinoma, the cholangiocarcinoma also must have a grading of G1 / G2
• response to chemotherapy in terms of stable or regressive disease (imaging studies, tumor marker CA19-9, any chemotherapy regime allowed, a local-ablative therapy in means of a SIRT is mandatory
• peritoneal carcinosis / extrahepatic spread ruled out in PET-CT and/or MRT/CT and, at latest, during exploration
• age ≥ 18
• blood-group compatible living donor available
• in female patients: negative pregnancy test
• written informed consent before study enrolment of donor and recipient (all other procedures are clinical routine procedures in the management of these patients)

You may not qualify if:

• extrahepatic tumor/metastases
• G3 tumors
• progress under neoadjuvant treatment according to the RECIST-criteria
• pregnancy or breastfeeding
• patients unwilling to consent to saving and propagation of pseudonymized medical data for study reasons
• general contraindications for liver transplantation

Sponsors & Collaborators

• Jena University Hospital: lead

Related Publications (5)

• Goldaracena N, Gorgen A, Sapisochin G. Current status of liver transplantation for cholangiocarcinoma. Liver Transpl. 2018 Feb;24(2):294-303. doi: 10.1002/lt.24955.

  PMID: 29024405 BACKGROUND

• Ziogas IA, Giannis D, Economopoulos KP, Hayat MH, Montenovo MI, Matsuoka LK, Alexopoulos SP. Liver Transplantation for Intrahepatic Cholangiocarcinoma: A Meta-analysis and Meta-regression of Survival Rates. Transplantation. 2021 Oct 1;105(10):2263-2271. doi: 10.1097/TP.0000000000003539.

  PMID: 33196623 BACKGROUND

• Chan KM, Tsai CY, Yeh CN, Yeh TS, Lee WC, Jan YY, Chen MF. Characterization of intrahepatic cholangiocarcinoma after curative resection: outcome, prognostic factor, and recurrence. BMC Gastroenterol. 2018 Dec 4;18(1):180. doi: 10.1186/s12876-018-0912-x.

  PMID: 30514231 BACKGROUND

• Lunsford KE, Javle M, Heyne K, Shroff RT, Abdel-Wahab R, Gupta N, Mobley CM, Saharia A, Victor DW, Nguyen DT, Graviss EA, Kaseb AO, McFadden RS, Aloia TA, Conrad C, Li XC, Monsour HP, Gaber AO, Vauthey JN, Ghobrial RM; Methodist-MD Anderson Joint Cholangiocarcinoma Collaborative Committee (MMAJCCC). Liver transplantation for locally advanced intrahepatic cholangiocarcinoma treated with neoadjuvant therapy: a prospective case-series. Lancet Gastroenterol Hepatol. 2018 May;3(5):337-348. doi: 10.1016/S2468-1253(18)30045-1. Epub 2018 Mar 13.

  PMID: 29548617 BACKGROUND

• McMillan RR, Javle M, Kodali S, Saharia A, Mobley C, Heyne K, Hobeika MJ, Lunsford KE, Victor DW 3rd, Shetty A, McFadden RS, Abdelrahim M, Kaseb A, Divatia M, Yu N, Nolte Fong J, Moore LW, Nguyen DT, Graviss EA, Gaber AO, Vauthey JN, Ghobrial RM. Survival following liver transplantation for locally advanced, unresectable intrahepatic cholangiocarcinoma. Am J Transplant. 2022 Mar;22(3):823-832. doi: 10.1111/ajt.16906. Epub 2021 Dec 27.

  PMID: 34856069 BACKGROUND

MeSH Terms

Conditions

Cholangiocarcinoma

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Utz Settmacher, Prof

  Jena University Hospital

  STUDY DIRECTOR

• Falk Rauchfuss, Prof

  Jena University Hospital

  STUDY DIRECTOR

• Laura Schwenk, MD

  Jena University Hospital

  STUDY DIRECTOR

Central Study Contacts

Falk Rauchfuss, Prof

CONTACT

0049 3641 9 322695; falk.rauchfuss@med.uni-jena.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med. Falk Rauchfuß, Sectio head liver transplantation, Principal investigator

Model Details: Curative treatment of unresectable intrahepatic cholangiocarcinoma via living donor donation and one- or two-staged hepatectomy

Study Record Dates

• First Submitted: July 30, 2024
• First Posted: August 6, 2024
• Study Start: September 1, 2024
• Primary Completion (Estimated): October 1, 2030
• Study Completion (Estimated): October 1, 2031
• Last Updated: August 6, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share