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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06390228
Other study ID # 2023-RE-285
Secondary ID No. 82172071
Status Completed
Phase
First received
Last updated
Start date January 1, 2019
Est. completion date August 1, 2023

Study information

Verified date April 2024
Source Anhui Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Hepatectomy is the first option for the treatment of hepatocellular carcinoma(HCC) at CNLC Ib stage. HCC patients who undergo curative hepatectomy may experience varying remnant liver volumes and thus leads to different oncological outcomes.


Description:

Patients with hepatocellular carcinoma (HCC) who undergo curative hepatectomy may experience varying remnant liver volumes. The investigators aimed to evaluate whether the extent of liver resection has an effect on postoperative recurrence in HCC patients. A retrospective analysis was conducted on 197 patients who underwent hepatectomy for a solitary HCC lesion measuring ≥5 cm between January 2019 and June 2022. Patients were divided into major hepatectomy (MAH) group (n=70) and minor hepatectomy (MIH) group (n=127) based on the extent of liver resection. Recurrence-free survival (RFS) was compared between the two groups. Propensity score matching was employed to mitigate potential biases in this research.


Recruitment information / eligibility

Status Completed
Enrollment 197
Est. completion date August 1, 2023
Est. primary completion date August 1, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria: - histologically confirmed solitary HCC with a size of =5 cm - Eastern Cooperative Oncology Group score of 0 or 1 - preoperative indocyanine green retention rate at 15 minutes =15% and Child-Pugh A classification - no evidence of vascular invasion or extrahepatic disease. Exclusion Criteria: - not diagnosed with HCC or had an HCC measuring <5 cm - had confirmed tumor metastases or macrovascular invasion based on radiological examinations - died within 90 days after surgery were excluded

Study Design


Intervention

Procedure:
Major hepatectomy
the extent of liver resection

Locations

Country Name City State
China Anhui Provincial Hospital Hefei Anhui

Sponsors (2)

Lead Sponsor Collaborator
Anhui Medical University National Natural Science Foundation of China

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary recurrence-free survival the time from the time of radical surgery to the time of HCC recurrence 2019.1-2023.8
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