Resection And Partial Liver Segmental Transplantation With Delayed Total Hepatectomy

Not Applicable

Recruiting

• Conditions: Liver Metastases
• Interventions: Procedure: Liver transplantation

• Registration Number: NCT04865471
• Lead Sponsor: Azienda Ospedaliera di Padova

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-01
• Study First Submitted: 2021-02-23
• Study First Submitted QC: 2021-04-28
• Study First Posted: 2021-04-29
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-22
• Last Update Posted: 2024-04-23
• Primary Completion: 2025-10
• Study Completion: 2025-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 18

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Liver transplantation	Liver transplantation	Auxiliary liver transplantation and staged hepatectomy

Primary Outcome Measures

Name	Time	Method
Percent of transplanted patients receiving second stage hepatectomy within 4 weeks of segment 2/3 transplantation	within 4 weeks from liver transplantation	Rate of second stage hepatectomy performed within 4 weeks from transplatation

Secondary Outcome Measures

Name	Time	Method
Mortality	within 90 days from second stage hepatectomy	Rate of death within 90 days after second stage hepatectomy
Proportion of drop out	within 100 days from listing	Rate of drop out from listing
Progression free survival	3 and 5 years	Time from enrolement to either progression or censoring
Intention to treat survival after liver transplantation	3 and 5 years	Time from transplantation to either death or censoring
Complication rate	within 90 days after liver transplant	Complications according to Dindo Clavien Classification

Trial Locations

Locations (1)

U.O.C Chirurgia Epatobiliare e Trapianti Epatici, Azienda Ospedaliera di Padova; 🇮🇹 Padova, Italy