Clinical Trial: Laparoscopic Hepatectomy Versus Open Hepatectomy for PHC

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Laparoscopic Hepatectomy Versus Open Hepatectomy for PHC With a Tumor Size of 5-10cm:a Prospective Case-control Study

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 Summary:

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.

Sponsor: Shuguo Zheng, MD

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome: intraoperative parameters [ Time Frame: during the operation ]

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


Original Secondary Outcome: Same as current

Information By: Southwest Hospital, China

Dates:
Date Received: December 8, 2013
Date Started: March 2013
Date Completion:
Last Updated: August 8, 2015
Last Verified: August 2015