Resection And Partial Liver Segmental Transplantation With Delayed Total Hepatectomy (RAPID-Padova)

University of Padua

Status: Enrolling

Conditions: Liver Metastases

Treatments: Procedure: Liver transplantation

Study type: Interventional

Funder types: Other

Identifiers

NCT04865471

AOP1838

Details and patient eligibility

About

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.

Enrollment: 18 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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18 participants in 1 patient group

Liver transplantation

Experimental group

Description:

Auxiliary liver transplantation and staged hepatectomy

Treatment:

Procedure: Liver transplantation