NCT06390228

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
197

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2023

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

April 24, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 30, 2024

Completed
Last Updated

April 30, 2024

Status Verified

April 1, 2024

Enrollment Period

4.6 years

First QC Date

April 24, 2024

Last Update Submit

April 26, 2024

Conditions

Keywords

Hepatocellular Carcinomarecurrencehepatectomy

Outcome Measures

Primary Outcomes (1)

  • recurrence-free survival

    the time from the time of radical surgery to the time of HCC recurrence

    2019.1-2023.8

Study Arms (2)

Major hepatectomy

Major hepatectomy was defined as the removal of four or more Couinaud's liver segments.

Procedure: Major hepatectomy

Minor hepatectomy

Minor hepatectomy was defined as the removal of three or fewer Couinaud's segments.

Interventions

the extent of liver resection

Also known as: minor hepatectomy
Major hepatectomy

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Anhui Provincial Hospital

Hefei, Anhui, 230001, China

Location

MeSH Terms

Conditions

Carcinoma, HepatocellularRecurrence

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Dalong Yin, Ph.D

    The First Affiliated Hospital of University of Science and Technology of China

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

April 24, 2024

First Posted

April 30, 2024

Study Start

January 1, 2019

Primary Completion

August 1, 2023

Study Completion

August 1, 2023

Last Updated

April 30, 2024

Record last verified: 2024-04

Locations