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Completed

NCT Number: NCT04412161

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Liver Transplantation

Procedure

Living donor liver transplantation

Primary outcomes

  1. overall and disease free survivals

    Time frame: five years follow up

    to analyse the factors that effect the survivals

Sponsors and collaborators

Lead sponsor

Inonu University

Other

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2019
Study completion
2019
First posted
Jun 2, 2020
Registry last updated
Jun 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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