Clinical trial NCT02014025: 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
Overall status: COMPLETED
Phase: NA
Conditions: Primary Liver Carcinoma
Keywords: Laparoscope hepatectomy
Open hepatectomy
large PHC
safety and sensibility
Lead sponsor: Southwest Hospital, China
Sponsor class: OTHER
First posted: 2013-12-17
Enrollment: 335
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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:

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.

Eligibility 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

Primary outcomes:
measure: survival rate
timeFrame: 3-year
Secondary outcomes:
measure: intraoperative parameters
timeFrame: during the operation
Other outcomes:
measure: postoperative complications
timeFrame: Duration hospitalization(an expected average of 7 days)
Locations:
city: Chongqing
country: China
facility: Southwest Hospital
state: Chongqing
Study officials:
affiliation: Shuguo Zheng, MD Study Director Institute of Hepatobiliary Surgery ,Southwest Hospital ,Third Military Medical University
name: Shuguo Zheng
role: STUDY_DIRECTOR
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