Resection And Partial Liver Segmental Transplantation With Delayed Total Hepatectomy

NCT ID: NCT04865471

Last Updated: 2024-04-23

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-01
• Study Completion Date: 2025-10-31

Brief Summary

RAPID is an auxiliary liver transplantation where a small liver partial graft (namely left lateral segments from living or cadaveric donors) is implanted orthotopically after a left hepatectomy of the native liver. Subsequently, in order to implement a fast regeneration of the transplanted segments a portal flow diversion is operated in the direction of the future remnant. After obtaining a fast regeneration of the auxiliary future remnant liver the native liver hepatectomy is completed as in a two stage- hepatectomy. Peculiar inclusion criteria will be adopted for patient selection with particular reference to the admission of patients with <3 lung metastases radically treated before transplantation.

Conditions

Liver Metastases

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Liver transplantation

Auxiliary liver transplantation and staged hepatectomy

Group Type: EXPERIMENTAL

Liver transplantation

Intervention Type: PROCEDURE

Auxiliary liver transplantation and staged hepatectomy

Interventions

Liver transplantation

Auxiliary liver transplantation and staged hepatectomy

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• ≥ 18 and <70 years
• Performance status, ECOG 0-1
• Histologically proved adenocarcinoma in colon or rectum
• BRAF wild-type CRC on primary tumor or liver metastases
• High standard oncological surgical resection of the primary tumor
• Liver metastases not eligible for curative liver resection confirmed by the validation committee
• At least one line (3 months) of chemotherapy
• At least 6 months time span from CRC resection and date of being listed on the transplantation list.
• At least 8 weeks of tumor control: stable disease or partial response according to RECIST 1.1 criteria
• No signs of extra hepatic metastatic disease or local recurrence on CT, MRI and Pet-CT except patients may have <3 lung lesions all<15mm resected or treated by radiotherapy or metastatic hilar nodes treated by resection and without recurrence at 3 months from resection or radiotherapy.
• Satisfactory blood tests creatinine in normal level, PLT >60.000/mm3, GB>2500/mm3
• CEA stable or in decrease
• Signed informed consent and expected cooperation of the patients for the treatment and follow up

Exclusion Criteria

• Weight loss >10% the last 6 months
• Patient BMI > 30
• Participation refusal
• General contraindication to LT
• Other malignancies in the previous 5 years
• Pregnancy or breast feeding
• Any reason why, in the opinion of the investigator, the patient should not participate

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istituto Oncologico Veneto IRCCS

OTHER

Sponsor Role: collaborator

Azienda Ospedaliera di Padova

OTHER

Sponsor Role: lead

Responsible Party

Prof. Umberto Cillo

Prof

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

U.O.C Chirurgia Epatobiliare e Trapianti Epatici, Azienda Ospedaliera di Padova

Padua, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Umberto Cillo, MD

Role: CONTACT

cillo@unipd.it

049.8212211-1897 ext. +39

Sara Lonardi, MD

Role: CONTACT

sara.lonardi@iov.veneto.it

Facility Contacts

Umberto Cillo, MD

Role: primary

cillo@unipd.it

Other Identifiers

AOP1838

Identifier Type: -

Identifier Source: org_study_id