Ignite Creation Date:
2024-05-06 @ 2:45 PM
Last Modification Date:
2024-10-26 @ 1:36 PM
Study NCT ID:
NCT04412161
Status:
COMPLETED
Last Update Posted:
2020-06-02
First Post:
2020-05-29
Brief Title:
Liver Transplant for Larger Hepatocellular Carcinoma in Malatya The Role of GGT and AFP
Sponsor:
Inonu University
Organization:
Inonu University
Study Overview
Official Title:
Retrospective Cohort Study-Analysis of LT Patients With HCC Maximum Tumor Diameter 6 cm
Status:
COMPLETED
Status Verified Date:
2020-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Retrospective data on 50 prospectively-collected HCC patients with beyond-Milan criteria with 6cm tumors were analyzed 5-year OS of 762 was found in patients with both AFP 200 ngml and GGT 104 IUmL with tumors less than 10 cm diameter Thus GGT values add to AFP in patient prognosis
Detailed Description:
BackgroundA retrospective analysis was performed of prospectively-collected transplant data on outcomes of patients with large size HCCsto examine possible prognostically-useful factorsMethodsA 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 levelsResultsUsing ROC analysis cutoff values of AFP 200 ngml and GGT 104 IUml 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 valuesEven greater differences in survival were found when the 2 parameters were combined with best survival 5-year OS of 762 versus 0 p0002The most consistent clinical correlates for these longer survivals were degree of tumor differentiation and absence of microscopic portal venous invasionTwo tumor size bands were identifiedto search for the limits of this approach with larger tumors namely 6-10 and 10cmCombination parameters in 6-10cm band reflected 5-year OS of 762 vs 0in patients with low AFP plus low GGT vs other groupsBeyond 10cmno patients had low AFP plus low GGTConclusionsAFP and GGTboth singly and together represent a simple prognostic identifier for patients with large size HCCs being treated by liver transplantation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None