Resection And Partial Liver Segmental Transplantation With Delayed Total Hepatectomy

NCT04865471 | Recruiting

• 1 other identifier: AOP1838
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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

Keywords

Colorectal Liver Metastases; Auxiliary Liver Transplant

Outcome Measures

Primary Outcomes (1)

• Percent of transplanted patients receiving second stage hepatectomy within 4 weeks of segment 2/3 transplantation

  Rate of second stage hepatectomy performed within 4 weeks from transplatation

  within 4 weeks from liver transplantation

Secondary Outcomes (5)

• Intention to treat survival after liver transplantation

  3 and 5 years

• Progression free survival

  3 and 5 years

• Proportion of drop out

  within 100 days from listing

• Mortality

  within 90 days from second stage hepatectomy

• Complication rate

  within 90 days after liver transplant

Study Arms (1)

Liver transplantation

EXPERIMENTAL

Auxiliary liver transplantation and staged hepatectomy

Procedure: Liver transplantation

Interventions

Liver transplantation PROCEDURE

Auxiliary liver transplantation and staged hepatectomy

Liver transplantation

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Azienda Ospedaliera di Padova: lead
• Istituto Oncologico Veneto IRCCS: collaborator

Study Sites (1)

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

Padua, 35128, Italy

RECRUITING

MeSH Terms

Interventions

Liver Transplantation

Intervention Hierarchy (Ancestors)

Tissue Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Digestive System Surgical Procedures; Surgical Procedures, Operative; Organ Transplantation; Transplantation

Central Study Contacts

Umberto Cillo, MD

CONTACT

049.8212211-1897; cillo@unipd.it

Sara Lonardi, MD

CONTACT

sara.lonardi@iov.veneto.it

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

Study Record Dates

• First Submitted: February 23, 2021
• First Posted: April 29, 2021
• Study Start: October 1, 2020
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: April 23, 2024

Record last verified: 2024-04

Locations

IT (1)