Laparoscopic Versus Open Liver Resection for Hepatocellular Carcinoma

August 16, 2022 updated by: Lunxiu Qin, Fudan University

A Prospective Randomized Control Trail of Laparoscopic Versus Open Liver Resection for Hepatocellular Carcinoma

The purpose of the study is to observe the curative effect and safety of laparoscopic versus open liver resection for hepatocellular carcinoma.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Liver resection is the most important treatment of hepatocellular carcinoma (HCC). Open hepatectomy was regarded as a giant surgery because of its big incision, influence of the liver function, and long hospital stay. Laparoscopic hepatectomy was widely used since it was reported by Reich in 1991. With the constant innovation of laparoscopic technique and equipment, there is no penalty area in laparoscopic hepatectomy. The Louisville consensus proposed that the best indication for laparoscopic hepatectomy was the tumor diameter < 5cm, located in segment II-VI.

Previous studies shows that compared with the open surgery, laparoscopic hepatectomy has the advantages of shorter operation time, less bleeding, shorter hospitalization time. The mortality, mobility, the overall survival and the disease-free survival was same in these two groups.

So far, however, the curative effect and safety research of laparoscopic versus open liver resection for HCC is limited to retrospective study and case-control study. A prospective, randomized, controlled study is urgently needed.

This study was proceeded to observe the curative effect and safety of laparoscopic versus open liver resection for HCC.

Study Type

Interventional

Enrollment (Actual)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China, 200040
        • Huashan Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Diagnosis was HCC
  2. The tumor was located in segment: II, III, IVb, V, VI
  3. The tumor diameter < 5cm
  4. Without thrombosis in the portal vein, hepatic vein or bile duct
  5. Without intrahepatic and systemic metastasis
  6. The Child-pugh score was A-B7
  7. The ASA（American Society of Anesthesiologists） score was I-III
  8. The patient age was between 18-75
  9. Sign the informed consent, and can fully understand the research content

Exclusion Criteria:

  1. Have surgery contraindications
  2. Pregnant or lactating women
  3. The Child-pugh score was B8-C
  4. The ASA（American Society of Anesthesiologists） score was IV-V
  5. With other malignant tumor
  6. With mental illness
  7. Participated in other clinical trials in the last three months
  8. Underwent other treatments(chemotherapy or radiotherapy) before operation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: laparoscopic hepatectomy
The HCC patients who meet the Louisville consensus will be underwent the liver resection by laparoscopic surgery
Procedure: laparoscopic hepatectomy
The HCC patients who meet the Louisville consensus will underwent liver resection by laparoscopy
Experimental: Open hepatectomy
The HCC patients who meet the Louisville consensus will be underwent the liver resection by open surgery
Procedure: Open hepatectomy
The HCC patients who meet the Louisville consensus will underwent liver resection by open surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 5 years
The overall survival of HCC patients after operation
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease free survival
Time Frame: 5 years
The disease free survival of HCC patients after operation
5 years
Incidence of postoperative complications
Time Frame: 1 month
Incidence of postoperative complications
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fudan University

Investigators

  • Principal Investigator: Lunxiu Qin, MD, Department of general surgery, Huashan hospital, Fudan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2015

Primary Completion (Anticipated)

December 1, 2022

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

August 5, 2015

First Submitted That Met QC Criteria

August 14, 2015

First Posted (Estimate)

August 18, 2015

Study Record Updates

Last Update Posted (Actual)

August 18, 2022

Last Update Submitted That Met QC Criteria

August 16, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Huashan 002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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