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Laparoscopic Hepatectomy Versus Open Hepatectomy for PHC

Primary Purpose

Primary Liver Carcinoma

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Open hepatectomy
Laparoscope hepatectomy
Sponsored by
Shuguo Zheng, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Liver Carcinoma focused on measuring Laparoscope hepatectomy, Open hepatectomy, large PHC, safety and sensibility

Eligibility Criteria

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

Inclusion Criteria:

  • Inclusion criteria for the Laparoscope hepatectomy group are:

    1. both male and female, aged 18 to 70;
    2. PHC diagnosis is clear preoperative;
    3. No active hepatitis and decompensated cirrhosis
    4. tumor size of 5-10 cm,no intrahepatic or distant metastasis,no tumor thrombus in the portal vein, hepatic vein, vena cava, or bile duct; and no invasion of the diaphragm or surrounding tissues;
    5. no rupture or bleeding of the tumor;
    6. Child-Pugh class A or B liver function;
    7. indocyanine green retention rate at 15 min of <15%, and a remnant liver volume/standard liver volume ratio of >50% in patients with liver cirrhosis and >35% in patients without liver cirrhosis;
    8. upper abdominal surgery, radiofrequency ablation, Transhepatic Arterial Chemotherapy And Embolization treatment, radiotherapy and chemotherapy have not been implemented and no previous surgery that absolutely contraindicated Laparoscope hepatectomy.
    9. General condition of patients and cardiopulmonary function enough to tolerate surgery
    10. voluntary participation in the study, and informed consent.
  • Inclusion criteria for the Open hepatectomy group are:

meet the criteria for Laparoscope hepatectomy group;

Exclusion Criteria:

  • (1) age <18 years or> 70 years , pregnant or lactating women; (2) tumor size ≥10 cm, or tumor location that would interfere with intraoperative exposure and isolation of the hepatic hilum; (3) tumor encroaching on the hepatic hilum , the portal vein, primary bile duct or tumor adjacent to the major vascular structures ; (4) unable to tolerate a pneumoperitoneum or can't tolerate surgery duo to cardiopulmonary dysfunction; (5) severe upper abdominal adhesions; (6)Pathologically confirmed positive margins

Sites / Locations

  • Southwest Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

laparoscope hepatectomy

open hepatectomy

Arm Description

We let the 45 patients who are meet the inclusion criteria .Hospital in hepatobiliary surgery E district is Group B ,they will accept laparoscopic hepatectomy: tumors are totally resected through laparoscopic.

We let the 45 patients who are meet the inclusion criteria .Hospital in hepatobiliary surgery A and D district is Group A ,they will accept Open Hepatectomy: tumors are totally resected by conventional laparotomy.

Outcomes

Primary Outcome Measures

survival rate
follow-up after the surgery every 3months, to understand relapse, death, statistics 1-year, 3-year overall survival rates,disease-free survival rates , recurrence and metastasis rate.

Secondary Outcome Measures

intraoperative parameters
operation time, intraoperative blood loss, rate of blood transfusion, tumor resection margin.

Full Information

First Posted
December 8, 2013
Last Updated
August 8, 2015
Sponsor
Shuguo Zheng, MD
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1. Study Identification

Unique Protocol Identification Number
NCT02014025
Brief Title
Laparoscopic Hepatectomy Versus Open Hepatectomy for PHC
Official Title
Laparoscopic Hepatectomy Versus Open Hepatectomy for PHC With a Tumor Size of 5-10cm:a Prospective Case-control Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)

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 laparoscope hepatectomy and open hepatectomy, evaluate the safety and efficacy of laparoscope hepatectomy the PHC with a tumor size of 5~10㎝,and provide class B evidence based medicine for laparoscope hepatectomy for PHC with a tumor size of 5~10㎝.
Detailed Description
Background:primary hepatic carcinoma( PHC) is the world's most common and one of the most malignant tumors, the incidence of malignant tumors in the top five in the world, second only to mortality in gastric cancer, ranked No. 3. surgery and comprehensive treatment is recognized by the medical profession Surgical approach, surgical methods include open and laparoscopic liver resection .The safety and efficacy of laparoscopic resection small PHC has been recognized, but the safety and efficacy of laparoscopy PHC resection is still a dispute, that with a tumor size of 5~10㎝, the clinical evidence is a C or D grade level from the standard definition of evidence-based medicine literature which has been published , for laparoscopic liver resection versus open liver resection for these hepatocellular carcinoma prospective case-control study has not been reported. Intervention:We will let the 90 patients who meet the inclusion criteria .Patients in hepatobiliary surgery A, D district is undergo traditional open liver resection, hepatobiliary surgery E district is undergo laparoscopic liver resection. In addition to the surgery way is different, the rest treatments are same. Results: Clinical data include:operation time, intraoperative blood loss, volume of blood transfusion, Rate of blood transfusion, complications and mortality, postoperative liver function, resection margin, long-term curative effect and survival time were collected and analysed. Statistical method:groups t-test ,univariate/multivariate analysis, logistic regression analysis, mixed linear regression, Cox survival analysis ,Kaplan-Meier survival analysis,Log-rank curves were used.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Liver Carcinoma
Keywords
Laparoscope hepatectomy, Open hepatectomy, large PHC, safety and sensibility

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
335 (Actual)

8. Arms, Groups, and Interventions

Arm Title
laparoscope hepatectomy
Arm Type
Experimental
Arm Description
We let the 45 patients who are meet the inclusion criteria .Hospital in hepatobiliary surgery E district is Group B ,they will accept laparoscopic hepatectomy: tumors are totally resected through laparoscopic.
Arm Title
open hepatectomy
Arm Type
Experimental
Arm Description
We let the 45 patients who are meet the inclusion criteria .Hospital in hepatobiliary surgery A and D district is Group A ,they will accept Open Hepatectomy: tumors are totally resected by conventional laparotomy.
Intervention Type
Procedure
Intervention Name(s)
Open hepatectomy
Intervention Description
We let the 45 patients who are meet the inclusion criteria .Hospital in hepatobiliary surgery A and D district is Group A ,they will accept Open Hepatectomy: tumors are totally resected by conventional laparotomy.
Intervention Type
Procedure
Intervention Name(s)
Laparoscope hepatectomy
Intervention Description
We let the 45 patients who are meet the inclusion criteria .Hospital in hepatobiliary surgery E district is Group B ,they will accept Laparoscopic Hepatectomy: tumors are totally resected through laparoscopic.
Primary Outcome Measure Information:
Title
survival rate
Description
follow-up after the surgery every 3months, to understand relapse, death, statistics 1-year, 3-year overall survival rates,disease-free survival rates , recurrence and metastasis rate.
Time Frame
3-year
Secondary Outcome Measure Information:
Title
intraoperative parameters
Description
operation time, intraoperative blood loss, rate of blood transfusion, tumor resection margin.
Time Frame
during the operation
Other Pre-specified Outcome Measures:
Title
postoperative complications
Description
ascites, pleural effusion,cardiopulmonary insufficiency,mortality, postoperative liver function failure.
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
No
Eligibility Criteria
Inclusion Criteria: Inclusion criteria for the Laparoscope hepatectomy group are: both male and female, aged 18 to 70; PHC diagnosis is clear preoperative; No active hepatitis and decompensated cirrhosis tumor size of 5-10 cm,no intrahepatic or distant metastasis,no tumor thrombus in the portal vein, hepatic vein, vena cava, or bile duct; and no invasion of the diaphragm or surrounding tissues; no rupture or bleeding of the tumor; Child-Pugh class A or B liver function; indocyanine green retention rate at 15 min of <15%, and a remnant liver volume/standard liver volume ratio of >50% in patients with liver cirrhosis and >35% in patients without liver cirrhosis; upper abdominal surgery, radiofrequency ablation, Transhepatic Arterial Chemotherapy And Embolization treatment, radiotherapy and chemotherapy have not been implemented and no previous surgery that absolutely contraindicated Laparoscope hepatectomy. General condition of patients and cardiopulmonary function enough to tolerate surgery voluntary participation in the study, and informed consent. Inclusion criteria for the Open hepatectomy group are: meet the criteria for Laparoscope hepatectomy group; Exclusion Criteria: (1) age <18 years or> 70 years , pregnant or lactating women; (2) tumor size ≥10 cm, or tumor location that would interfere with intraoperative exposure and isolation of the hepatic hilum; (3) tumor encroaching on the hepatic hilum , the portal vein, primary bile duct or tumor adjacent to the major vascular structures ; (4) unable to tolerate a pneumoperitoneum or can't tolerate surgery duo to cardiopulmonary dysfunction; (5) severe upper abdominal adhesions; (6)Pathologically confirmed positive margins
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

12. IPD Sharing Statement

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Laparoscopic Hepatectomy Versus Open Hepatectomy for PHC

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