Clinical trial NCT06390228: Impact of Hepatectomy on HCC Recurrence
Official title: Impact of Major Hepatectomy on Recurrence After Resection of Hepatocellular Carcinoma at China Liver Cancer Staging (CNLC) Stage : a Propensity Score Matching Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatocellular Carcinoma Stage I
Recurrence
Keywords: Hepatocellular Carcinoma
recurrence
hepatectomy
Lead sponsor: Anhui Medical University
Sponsor class: OTHER
Collaborators: name: National Natural Science Foundation of China
First posted: 2024-04-30
Enrollment: 197
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: a final sample of 197 patients was included in this study. Among these patients, 70 underwent MAH (including 62 right hepatectomies, 4 extended right hepatectomies, and 4 extended left hepatectomies), while 127 patients underwent MIH (including 32 left hepatectomies, 10 right anterior hepatectomies, 17 right posterior hepatectomies, 11 mesohepatectomies, 20 left lateral hepatectomies, 21 right partial hepatectomies, 3 left partial hepatectomies, and 13 single segment hepatectomies). Using PSM analysis, 49 pairs of matched patients were identified from each group to compare outcomes.

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: recurrence-free survival
timeFrame: 2019.1-2023.8
Secondary outcomes:
Other outcomes:
Locations:
city: Hefei
country: China
facility: Anhui Provincial Hospital
state: Anhui
Study officials:
affiliation: The First Affiliated Hospital of University of Science and Technology of China
name: Dalong Yin, Ph.D
role: STUDY_DIRECTOR
References: