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

Hepatocellular Carcinoma Clinical Trial

Official title:

Retrospective Cohort Study-Analysis of LT Patients With HCC (Maximum Tumor Diameter > 6 cm).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04412161
• Other study ID #: GGT-HCC-6CM
• Status: Completed
• Start date: April 19, 2006
• Est. completion date: December 1, 2019

Study information

• Verified date: May 2020
• Source: Inonu University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 1, 2019
• Est. primary completion date: January 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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)

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma
• Liver Transplant Disorder

Intervention

Procedure:
• Liver transplantation
Living donor liver transplantation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Inonu University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall and disease free survivals	to analyse the factors that effect the survivals	five years follow up