The Intention-to-treat Effect of Bridge Therapies in the Setting of Milan-in Patients

NCT03723304 | Completed

• 1 other identifier: #0002
• Study Type: observational
• Target: 1,083
• Locations: 1 country
• Sites: 1

Brief Summary

In patients with hepatocellular cancer (HCC) meeting the Milan Criteria (MC), the usefulness of loco-regional therapies (LRT) in the context of liver transplantation (LT) is still debated. The inconsistent literature data are the result of initial selection biases among treated and untreated patients. In order to overcome these shortcomings, an inverse probability of treatment weighting (IPTW) analysis was done in a large patient cohort. After using a competing-risk analysis, the primary end-point of the study aims at identifying the risk factors of HCC-specific LT failure, defined as pre-LT tumour-related drop-out or post-LT recurrence.

Conditions

Liver Cancer; Transplant; Failure, Liver

Outcome Measures

Primary Outcomes (1)

• Tumour-specific liver transplant failure rate

  Any case of tumor-related drop-out during the waiting list period or post-transplant recurrence

  up to 5 years from first referral

Study Arms (2)

Direct liver transplant

All the cases listed for liver transplantation and then transplanted/dropped-out without undergoing any neo-adjuvant loco-regional treatment

Procedure: Direct liver transplant

Bridging followed by transplant

All the cases listed for liver transplantation and then transplanted/dropped-out after undergoing at least one neo-adjuvant loco-regional treatment

Procedure: Bridging followed by transplant

Interventions

Bridging followed by transplant PROCEDURE

Trans-arterial chemoembolization or percutaneous alcohol injection or radio-frequency ablation during the waiting time followed by liver transplant

Bridging followed by transplant

Direct liver transplant PROCEDURE

Direct liver transplant (no neoadjuvant approaches during the waiting time period)

Direct liver transplant

Eligibility Criteria

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

Study Population

Patients with radiological/post-bioptic diagnosis of hepatocellular cancer listed for liver transplantation receiving or not receiving any neo-adjuvant treatment before transplant/drop-out

You may qualify if:

• adults (≥18-year old) listed for liver transplant with a morphologic and/or histologic confirmed hepatocellular cancer

You may not qualify if:

• Milan Criteria-out status at first referral
• transplantation or de-listing before January 1, 2001
• other means of loco-regional treatments such as partial hepatectomy, trans-arterial radio-embolization or external radiotherapy
• misdiagnosed mixed hepatocellular-cholangiocellular cancer or cholangiocellular cancer

Sponsors & Collaborators

• European Hepatocellular Cancer Liver Transplant Group: lead

Study Sites (1)

UCL

Brussels, Belgium

Location

Related Publications (1)

• Lai Q, Vitale A, Iesari S, Finkenstedt A, Mennini G, Onali S, Hoppe-Lotichius M, Manzia TM, Nicolini D, Avolio AW, Mrzljak A, Kocman B, Agnes S, Vivarelli M, Tisone G, Otto G, Tsochatzis E, Rossi M, Viveiros A, Ciccarelli O, Cillo U, Lerut J; European Hepatocellular Cancer Liver Transplant Study Group. The Intention-to-Treat Effect of Bridging Treatments in the Setting of Milan Criteria-In Patients Waiting for Liver Transplantation. Liver Transpl. 2019 Jul;25(7):1023-1033. doi: 10.1002/lt.25492.

  PMID: 31087772 DERIVED

MeSH Terms

Conditions

Liver Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases

Study Officials

• Quirino Lai, MD PhD

  UCL Brussels

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2018
• First Posted: October 29, 2018
• Study Start: March 1, 2018
• Primary Completion: October 15, 2018
• Study Completion: October 15, 2018
• Last Updated: October 29, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)