Laparoscope Anatomical and Aon-anatomical Hepatectomy

February 10, 2022 updated by: Shuguo Zheng, MD

The Prospective, Randomized Case-control(RCT) Research of Laparoscope Anatomical and Aon-anatomical Hepatectomy Treat HCC

The purpose of this study is to compare short-term and long-term efficacy of two surgical methods by laparoscopic hepatectomy, and provide the evidence for the choice of surgical method from the pathology and cytology.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Background:Hepatocellular carcinoma is the world's most common and most malignant tumor, accounting for more than 90% of primary liver cancer, the incidence ranked fifth of malignant tumors in the world. surgery and comprehensive treatment is recognized by the medical profession Surgical approach, including the open HCC hepatectomy and laparoscopic hepatectomy, minimally invasive surgery is the main theme of the 21st century, and laparoscopy as the one of the elements in the field of minimally invasive surgery which carried out more and more in liver surgery, but which one of the two methods to choice to hepatectomy lack of sufficient scientific evidence.The RCT research of laparoscopic anatomical and non-anatomical hepatectomy for HCC has not been reported at home and abroad; Intervention:We let the 110 patients divide into A, B groups randomly who are meet the inclusion criteria .Group A is Laparoscopic Anatomical Hepatectomy: Anatomy the corresponding liver segment pedicle and hepatectomy along the Glisson fiber sheath.Group B is Laparoscopic Aon-anatomical Hepatectomy:1 to 2 cm along the edge of the tumor complete hepatectomy

Results:

  1. operation time, intraoperative blood loss, rate of blood transfusion, complications and mortality, postoperative liver function, resection margin, number of micrometastases ,long-term curative effect and survival time were collected and analysed.
  2. groups t-test ，univariate/multivariate analysis, logistic regression analysis, mixed linear regression, Cox survival analysis ，Kaplan-Meier survival analysis，Log-rank survival curves were used.

Study Type

Interventional

Enrollment (Anticipated)

110

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 Contact

Study Locations

  • China
    • Chongqing
      • Chongqing, Chongqing, China, 400038
        • Recruiting
        • Southwest Hospital
        • Contact:
        • Principal Investigator:
          • shuguo Zheng, professer

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 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • (1) both male and female, aged 18 to 70; (2) Hepatocellular carcinoma(HCC)diagnosis is clear preoperative; (3) preoperative liver function evaluation: Child-Pugh => B; (4) the lesions can be anatomical hepatectomy,( Indocyanine Green retention rate of 15 minutes) ICGR-15< 20%, the remaining liver volume is sufficient; (5) hepatic single lesions and tumor size between 3-10 cm, does not Invasion the main vein, hepatic artery and vein and major inferior vena cava, did not occur extrahepatic metastasis, and laparoscopic can complete resection; (6) surgery, radiofrequency ablation (RFA), TACE treatment, radiotherapy and chemotherapy have not been implemented (7) voluntary participation in the study, and informed consent.

Exclusion Criteria:

  • • (1) age <18 years or> 70 years , pregnant or lactating women; (2) HCC diagnosis is not clear; (3) preoperative liver function evaluation: Child-Pugh C grade; (4) ICGR-15> 20%, the remaining liver volume is insufficient (account for standard liver volume <35%); (5) preoperative tumor has ruptured, or has been undergoing surgery, radiofrequency ablation (RFA), transhepatic arterial chemotherapy and embolization(TACE) or radiotherapy and chemotherapy treatment; (6) preoperative examinations showed multiple (>3)liver lesion or tumor diameter <3 or> 10 cm, a clearly major portal vein, hepatic vein, inferior vena vein tumor thrombus; (7) extrahepatic metastasis; (8) cardio-pulmonary function and other diseases can not tolerate surgery; (9) the patient refused to sign the informed consent form; (10) the tumor has spread and / or lymph node metastasis intraoperative found ; (11) intraoperative found not to be the HCC, such as metastatic hepatic carcinoma, hilar cell carcinoma; (12) Histological examinations showed it is cholangio carcinoma, or mixed liver carcinoma; (13) foreign and Hong Kong, Macao, Taiwan or other areas, estimated that difficult to track, follow-up postoperative

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
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Laparoscop Anatomical Hepatectomy
Total laparoscopic anatomical hepatectomy were performed, combined with cholecystectomy when necessary. The intraoperative ultrasound, hepatic segmental staining were used selectively.
Procedure: Laparoscopic Anatomical Hepatectomy
We let the 110 patients divide into A, B groups randomly who are meet the inclusion criteria .Group A is Laparoscopic Anatomical Hepatectomy: Anatomy the corresponding liver segment pedicle and hepatectomy along the Glisson fiber sheath
ACTIVE_COMPARATOR: Laparoscope Aon-anatomical Hepatectomy
Total laparoscopic aon-anatomical hepatectomy were performed, combined with cholecystectomy when necessary. The intraoperative ultrasound or hepatic segmental staining will be used to ensure the tumour was completely resected.
Procedure: Laparoscopic Aon-anatomical Hepatectomy
We let the 110 patients divide into A, B groups randomly who are meet the inclusion criteria .Group B is Laparoscopic Aon-anatomical Hepatectomy:1 to 2 cm along the edge of the tumor complete hepatectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survival rate
Time Frame: 5 years
follow-up after the surgery every 2 months, to understand relapse, death, statistics 1 year, 3-year and 5-year survival, disease-free survival, recurrence rate.
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
postoperative complications
Time Frame: Duration hospitalization(an expected average of 7 days)
hepatic failure,hemorrhage,biliary leakage,ascites,intra-abdominal infection,pleural effusion,pulmonary infection,cardiac insufficiency.
Duration hospitalization(an expected average of 7 days)

Collaborators and Investigators

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

Sponsor

Shuguo Zheng, MD

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

March 1, 2013

Primary Completion (ANTICIPATED)

March 1, 2022

Study Completion (ANTICIPATED)

May 1, 2022

Study Registration Dates

First Submitted

December 8, 2013

First Submitted That Met QC Criteria

December 8, 2013

First Posted (ESTIMATE)

December 11, 2013

Study Record Updates

Last Update Posted (ACTUAL)

February 11, 2022

Last Update Submitted That Met QC Criteria

February 10, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SWHZSG003
  • zhengshuguo (Registry Identifier: zhengshuguo)

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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