Living Donor Liver Transplantation With Two Stage Hepatectomy for Patients With Isolated, Irresectable Colorectal Liver Metastases

NCT03488953 | Recruiting DMC

• 1 other identifier: AVG-001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

Nearly one third of patients with colorectal cancer develop liver metastases. It is well known that the achievement of a R0-situation is one of the most important factors for a positive long-term outcome. Despite further advantages in multimodal treatment concepts, only 20 - 30 % of the patients with metastases can be resected in curative intention. Recent studies, especially from Norway, have shown that liver transplantation might be a feasible option in well selected patients since the complete hepatectomy with subsequent liver transplantation can be an option for the achievement of a R0 situation. In this study, we pursue the strategy of two-stage hepatectomy combined with a left-lateral living donor liver transplantation. Inclusion criteria are as follows: non-resectable liver metastases of a primary colorectal carcinoma with an assumed portal-venous drainage of the tumor and at least a "stable disease" after a period of eight weeks systemic chemotherapy. Patients are excluded from the study if there is an extrahepatic tumor burden (with the exception of resectable lung metastases) or if the patient is not suitable for liver transplantation due to co-morbidities. The transplantation itself will be undertaken as a living donor liver transplantation where the left lateral liver lobe (liver segments 2 \& 3) from a healthy volunteer donor will serve as graft. Prior transplantation, a left hemihepatectomy in the recipient is performed and the left lateral graft will be transplanted in this position. At the end of the transplantation procedure, the right portal vein will be closed to induce a rapid growth of the graft. The second step, and therefore the completion of the operation is performed after a growth period of the transplanted left-lateral lobe: in this procedure, the right hemi-liver of the recipient will be removed and the patient is supposed to be free of tumor at this point in time.

Conditions

Colorectal Cancer Metastatic; Liver Metastases

Keywords

Liver transplantation; Two-stage hepatectomy; Living donor liver transplantation

Outcome Measures

Primary Outcomes (1)

• Overall survival three years after 2nd-stage of hepatectomy

  Overall survival three years after 2nd-stage of hepatectomy

  3 years

Secondary Outcomes (3)

• Disease-free survival three years after 2nd-stage of hepatectomy

  3 years

• Morbidity of the recipient

  3 years

• Morbidity of the donor

  3 years

Study Arms (1)

Transplantation Arm

OTHER

Procedure: Living donor liver transplantation with two-staged hepatectomy.

Interventions

Living donor liver transplantation with two-staged hepatectomy. PROCEDURE

Two-stage hepatectomy combined with transplantation of left-lateral lobe from a living donor.

Transplantation Arm

Eligibility Criteria

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

You may qualify if:

• Patients with irresectable colorectal liver metastases without extrahepatic tumor burden, except resectable pulmonary metastases
• stable disease or regression after at least eight weeks of systemic chemotherapy

You may not qualify if:

• comorbidities precluding liver transplantation
• extrahepatic tumor spread, except resectable pulmonary metastases
• progression during chemotherapy

Sponsors & Collaborators

• Jena University Hospital: lead
• University Hospital Tuebingen: collaborator

Study Sites (2)

Jena University Hospital

Jena, 07747, Germany

RECRUITING

University Hospital Tübingen

Tübingen, 72076, Germany

RECRUITING

Related Publications (1)

• Rauchfuss F, Nadalin S, Konigsrainer A, Settmacher U. Living donor liver transplantation with two-stage hepatectomy for patients with isolated, irresectable colorectal liver-the LIVER-T(W)O-HEAL study. World J Surg Oncol. 2019 Jan 8;17(1):11. doi: 10.1186/s12957-018-1549-5.

  PMID: 30621712 DERIVED

Central Study Contacts

Falk Rauchfuss, M.D., M.Sc.

CONTACT

004936419322601; Falk.Rauchfuss@med.uni-jena.de

Ulrike McCaulley, Study Nurse

CONTACT

004936419322694; Ulrike.McCaulley@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: Senior Surgeon

Study Record Dates

• First Submitted: March 15, 2018
• First Posted: April 5, 2018
• Study Start: April 10, 2018
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: July 31, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2)