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

NCT ID: NCT04412161

Last Updated: 2020-06-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-04-19

Study Completion Date

2019-12-01

Brief Summary

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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

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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.

Conditions

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Hepatocellular Carcinoma Liver Transplant Disorder

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Extra-Malatya

Liver transplant patients with MTD\>6 cm of HCC

Liver transplantation

Intervention Type PROCEDURE

Living donor liver transplantation

Interventions

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Liver transplantation

Living donor liver transplantation

Intervention Type PROCEDURE

Eligibility Criteria

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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)
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Inonu University

OTHER

Sponsor Role lead

Responsible Party

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Volkan Ince

MD, FEBS, Assoc.Prof

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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GGT-HCC-6CM

Identifier Type: -

Identifier Source: org_study_id

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