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Trial record 6 of 14 for:    15761078 [PUBMED-IDS]

Laparoscopic Hepatectomy Versus Open Hepatectomy for PHC

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ClinicalTrials.gov Identifier: NCT02014025
Recruitment Status : Completed
First Posted : December 17, 2013
Last Update Posted : August 11, 2015
Sponsor:
Information provided by (Responsible Party):
Shuguo Zheng, MD, Southwest Hospital, China

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㎝.

Condition or disease Intervention/treatment Phase
Primary Liver Carcinoma Procedure: Open hepatectomy Procedure: Laparoscope hepatectomy Not Applicable

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:

  1. 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.
  2. 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 335 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Laparoscopic Hepatectomy Versus Open Hepatectomy for PHC With a Tumor Size of 5-10cm:a Prospective Case-control Study
Study Start Date : March 2013
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: laparoscope hepatectomy
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.
Procedure: Laparoscope hepatectomy
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.

Experimental: open hepatectomy
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.
Procedure: Open hepatectomy
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.




Primary Outcome Measures :
  1. survival rate [ Time Frame: 3-year ]
    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 :
  1. intraoperative parameters [ Time Frame: during the operation ]
    operation time, intraoperative blood loss, rate of blood transfusion, tumor resection margin.


Other Outcome Measures:
  1. postoperative complications [ Time Frame: Duration hospitalization(an expected average of 7 days) ]
    ascites, pleural effusion,cardiopulmonary insufficiency,mortality, postoperative liver function failure.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02014025


Locations
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China, Chongqing
Southwest Hospital
Chongqing, Chongqing, China, 400038
Sponsors and Collaborators
Shuguo Zheng, MD
Investigators
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Study Director: Shuguo Zheng Shuguo Zheng, MD Study Director Institute of Hepatobiliary Surgery ,Southwest Hospital ,Third Military Medical University

Publications:

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Responsible Party: Shuguo Zheng, MD, Professor of Hepatobiliary Surgery Institute; Chief Physician; Administrator of laparoscopic department, Southwest Hospital, China
ClinicalTrials.gov Identifier: NCT02014025     History of Changes
Other Study ID Numbers: SWHZSG004
Zhengshuguo ( Registry Identifier: Zhengshuguo )
First Posted: December 17, 2013    Key Record Dates
Last Update Posted: August 11, 2015
Last Verified: August 2015
Keywords provided by Shuguo Zheng, MD, Southwest Hospital, China:
Laparoscope hepatectomy
Open hepatectomy
large PHC
safety and sensibility
Additional relevant MeSH terms:
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Carcinoma, Hepatocellular
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases