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CompletedNCT04412161Updated Jun 2, 2020

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

An observational study in Hepatocellular Carcinoma and Liver Transplant Disorder, sponsored by Inonu University. Completed. Per ClinicalTrials.gov, last updated 2020-06-02.

Sponsored by Inonu University · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
50
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Hepatocellular Carcinoma
  • Liver Transplant Disorder

Keywords

  • Hepatic malignancy
  • GGT
  • living donor
03

In context

Carcinoma

6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.

This study's enrollment of 50 is below the median of 149 across 1,175 observational studies indexed under Carcinoma.

Browse Carcinoma studies →

Lead sponsor

Inonu University is the lead sponsor of 375 studies on the registry; 86 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

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

Exclusion criteria

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)
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
50 participants (actual)
Patient registry
No

Groups and cohorts

  • Extra-Malatya

    Liver transplant patients with MTD\>6 cm of HCC

    Procedure: Liver transplantation

Interventions

  • ProcedureLiver transplantation

    Living donor liver transplantation

06

What researchers measure

Primary outcomes

  1. overall and disease free survivals

    to analyse the factors that effect the survivals

    Time frame: five years follow up

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 2, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04412161
Lead sponsor
Inonu University
Responsible party
Volkan Ince (MD, FEBS, Assoc.Prof, Inonu University) — Principal investigator
First posted
Jun 2, 2020
Start date
Apr 19, 2006
Primary completion
Jan 1, 2019
Completion
Dec 1, 2019
Last update
Jun 2, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2020. You cannot join it, but the record below documents what was studied.

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