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Laparoscope Anatomical and Aon-anatomical Hepatectomy

Primary Purpose

Hepatocellular Carcinoma

Status

Recruiting

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Laparoscopic Anatomical Hepatectomy

Laparoscopic Aon-anatomical Hepatectomy

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring Hepatocellular Carcinoma, Laparoscopic, Aon-anatomical hepatectomy, Anatomical hepatectomy, Micrometastases

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Southwest HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Laparoscop Anatomical Hepatectomy

Laparoscope Aon-anatomical Hepatectomy

Arm Description

Total laparoscopic anatomical hepatectomy were performed, combined with cholecystectomy when necessary. The intraoperative ultrasound, hepatic segmental staining were used selectively.

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.

Outcomes

Primary Outcome Measures

Survival rate

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.

Secondary Outcome Measures

postoperative complications

hepatic failure,hemorrhage,biliary leakage,ascites,intra-abdominal infection,pleural effusion,pulmonary infection,cardiac insufficiency.

Full Information

NCT ID

NCT02009176

First Posted

December 8, 2013

Last Updated

February 10, 2022

Sponsor

Shuguo Zheng, MD

1. Study Identification

Unique Protocol Identification Number

NCT02009176

Brief Title

Laparoscope Anatomical and Aon-anatomical Hepatectomy

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2022

Overall Recruitment Status

Recruiting

Study Start Date

March 2013 (undefined)

Primary Completion Date

March 2022 (Anticipated)

Study Completion Date

May 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Shuguo Zheng, MD

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

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: 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatocellular Carcinoma

Keywords

Hepatocellular Carcinoma, Laparoscopic, Aon-anatomical hepatectomy, Anatomical hepatectomy, Micrometastases

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

110 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Laparoscop Anatomical Hepatectomy

Arm Type

Experimental

Arm Description

Total laparoscopic anatomical hepatectomy were performed, combined with cholecystectomy when necessary. The intraoperative ultrasound, hepatic segmental staining were used selectively.

Arm Title

Laparoscope Aon-anatomical Hepatectomy

Arm Type

Active Comparator

Arm Description

Intervention Type

Procedure

Intervention Name(s)

Laparoscopic Anatomical Hepatectomy

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Laparoscopic Aon-anatomical Hepatectomy

Intervention Description

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

Primary Outcome Measure Information:

Title

Survival rate

Description

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.

Time Frame

5 years

Secondary Outcome Measure Information:

Title

postoperative complications

Description

hepatic failure,hemorrhage,biliary leakage,ascites,intra-abdominal infection,pleural effusion,pulmonary infection,cardiac insufficiency.

Time Frame

Duration hospitalization(an expected average of 7 days)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Shuguo Zheng

Phone

0086-13508308676

shuguozh@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Shuguo Zheng

Organizational Affiliation

Shuguo Zheng, MD Study Director Institute of Hepatobiliary Surgery ,Southwest Hospital ,Third Military Medical University

Official's Role

Study Director

Facility Information:

Facility Name

Southwest Hospital

City

Chongqing

State/Province

Chongqing

ZIP/Postal Code

400038

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Shuguo Zheng, Professor

Phone

0086-13508308676

shuguozh@gmail.com

First Name & Middle Initial & Last Name & Degree

shuguo Zheng, professer

12. IPD Sharing Statement

Citations:

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Laparoscope Anatomical and Aon-anatomical Hepatectomy

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