Liver Transplant for Larger Hepatocellular Carcinoma in Malatya: The Role of GGT and AFP

Completed

• Conditions: Hepatocellular Carcinoma; Liver Transplant Disorder
• Interventions: Procedure: Liver transplantation

• Registration Number: NCT04412161
• Lead Sponsor: Inonu University

Brief Summary

Retrospective data on 50 prospectively-collected HCC patients with beyond-Milan criteria with \>6cm tumors were analyzed. 5-year OS of 76.2% was found in patients with both AFP \<200 ng/ml and GGT \<104 IU/mL with tumors less than 10 cm diameter. Thus, GGT values add to AFP in patient prognosis.

Detailed Description

Background:A retrospective analysis was performed of prospectively-collected transplant data on outcomes of patients with large size HCCs,to examine possible prognostically-useful factors.Methods:A total of 50 patients having tumors greater than 6cm maximum diameter were identified. Their survival and full clinical characteristics were examined, with respect to serum AFP and GGT levels.Results:Using ROC analysis, cutoff values of AFP 200 ng/ml and GGT 104 IU/ml were identified and used in this study. Significantly longer overall-survival and disease-free-survival were found for patients who had lower values of either parameter, compared with higher values.Even greater differences in survival were found when the 2 parameters were combined, with best survival (5-year OS of 76,2% versus 0%, p=0.002).The most consistent clinical correlates for these longer survivals were degree of tumor differentiation and absence of microscopic portal venous invasion.Two tumor size bands were identified,to search for the limits of this approach with larger tumors, namely 6-10 and \>10cm.Combination parameters in 6-10cm band reflected 5-year OS of 76,2% vs. 0%,in patients with low AFP plus low GGT vs. other groups.Beyond 10cm,no patients had low AFP plus low GGT.Conclusions:AFP and GGT,both singly and together, represent a simple prognostic identifier for patients with large size HCCs being treated by liver transplantation.

Study Timeline

• Study Start: 2006-04-19
• Primary Completion: 2019-01-01
• Study Completion: 2019-12-01
• Status Verified: 2020-05
• Study First Submitted: 2020-05-29
• Study First Submitted QC: 2020-05-29
• Last Update Submitted: 2020-05-29
• Study First Posted: 2020-06-02
• Last Update Posted: 2020-06-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Liver transplant patients with maximum tumor diameter greater than 6 cm of hepatocellular carcinoma

Exclusion Criteria

• Early postoperative mortality (within 90 days)
• Advanced stage tumors (explant patology revealed that tumor continues in the surgical cite such as positive lymph node metastases, macroscopic portal vein trombosis, diaphragmatic invasion, etc)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Extra-Malatya	Liver transplantation	Liver transplant patients with MTD\>6 cm of HCC

Primary Outcome Measures

Name	Time	Method
overall and disease free survivals	five years follow up	to analyse the factors that effect the survivals