Efficacy of Loco-regional Treatment for Hepatocellular Carcinoma Prior to Living Donor Liver Transplantation in Egypt

Completed

• Conditions: Hepatocellular Carcinoma (HCC); Living Donor Liver Transplantation
• Interventions: Procedure: loco regional therapies for HCC

• Registration Number: NCT02990351
• Lead Sponsor: Ain Shams University

Brief Summary

This study aimed to analyze the outcomes of loco-regional treatment prior Living Donor Liver Transplantation in patients with HCC.

Detailed Description

50 patients received LDLT at Ain Shams Centre for Organ Transplantation (ASCOT) over 1 year of whom data of 29 HCC patients were analyzed. Twenty patients met the Milan criteria (68.97%) \& 4 (13.8%) were beyond Milan but met UCSF criteria and 5 were exceeding UCSF criteria (17.2%).All patients underwent preoperative LRTs, The protocol of bridging/down staging, methods, duration of follow up, the number of the patients who were successfully down-staged before LT and their outcomes after LT were recorded.

Study Timeline

• Study Start: 2014-12
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2016-12
• Study First Submitted: 2016-12-04
• Study First Submitted QC: 2016-12-08
• Last Update Submitted: 2016-12-08
• Study First Posted: 2016-12-13
• Last Update Posted: 2016-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

Inclusion Criteria

1. Adult patients 18-65 years
2. Patients transplanted for HCC within Milan and UCSF criteria who underwent pre transplant bridge or down staging treatment for HCC

Exclusion Criteria

1. Tumor progression on the waiting list
2. Vascular invasion by imaging studies
3. Extrahepatic or lymph node metastasis

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
HCC patients	loco regional therapies for HCC	29 HCC patients who had loco regional therapies for HCC were analyzed. Twenty patients met the Milan criteria (68.97%) \& 4 (13.8%) were beyond Milan but met UCSF criteria and 5 were exceeding UCSF criteria (17.2%).All patients underwent preoperative LRTs, The protocol of bridging/down staging, methods, duration of follow up, the number of the patients who were successfully down-staged before LT and their outcomes after LT were recorded.

Primary Outcome Measures

Name	Time	Method
Radiological Response ( complete / partial / tumour progression)in the Radiology (CT/ MRI) before transplantation	3 months	the success of loco-regional therapy for hepatocellular carcinoma in term of radiological complete or partial response in the last spiral triphasic abdominal CT and /or MRI before transpalantation

Secondary Outcome Measures

Name	Time	Method
the degree of accuracy between the last CT/ MRI and the pathology of explant in term of number , size and ablation (complete necrosis ) for HCC	3 months	1. presence of viable tumour tissue in the explant pathology,; 2. mictro vascular invasion; 3. capsular or lymph node invasion the degree of accuracy between the last CT/ MRI and the pathology of explant