Neoplasms

All Conditions

Digestive System Diseases

Rare Diseases

Carcinoma

Carcinoma, Hepatocellular

Adenocarcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Liver Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Primary Liver Cancer

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.

Open 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.

Laparoscope hepatectomy

Shuguo Zheng

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㎝.

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.

Laparoscopic Hepatectomy Versus Open Hepatectomy for PHC

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

ascites, pleural effusion,cardiopulmonary insufficiency,mortality, postoperative liver function failure.

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.

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

Shuguo Zheng, MD

Professor of Hepatobiliary Surgery Institute; Chief Physician; Administrator of laparoscopic department

Hematinics

All Drugs and Chemicals

Liver Extracts

The HCC patients who meet the Louisville consensus will be underwent the liver resection by laparoscopic surgery

The HCC patients who meet the Louisville consensus will be underwent the liver resection by open surgery

The HCC patients who meet the Louisville consensus will underwent liver resection by laparoscopy

laparoscopic hepatectomy

The HCC patients who meet the Louisville consensus will underwent liver resection by open surgery

Lunxiu Qin, MD

The purpose of the study is to observe the curative effect and safety of laparoscopic versus open liver resection for hepatocellular carcinoma.

Liver resection is the most important treatment of hepatocellular carcinoma (HCC). Open hepatectomy was regarded as a giant surgery because of its big incision, influence of the liver function, and long hospital stay. Laparoscopic hepatectomy was widely used since it was reported by Reich in 1991. With the constant innovation of laparoscopic technique and equipment, there is no penalty area in laparoscopic hepatectomy. The Louisville consensus proposed that the best indication for laparoscopic hepatectomy was the tumor diameter \< 5cm, located in segment II-VI.

Previous studies shows that compared with the open surgery, laparoscopic hepatectomy has the advantages of shorter operation time, less bleeding, shorter hospitalization time. The mortality, mobility, the overall survival and the disease-free survival was same in these two groups.

So far, however, the curative effect and safety research of laparoscopic versus open liver resection for HCC is limited to retrospective study and case-control study. A prospective, randomized, controlled study is urgently needed.

This study was proceeded to observe the curative effect and safety of laparoscopic versus open liver resection for HCC.

Laparoscopic Versus Open Liver Resection for Hepatocellular Carcinoma

A Prospective Randomized Control Trail of Laparoscopic Versus Open Liver Resection for Hepatocellular Carcinoma

The overall survival of HCC patients after operation

The disease free survival of HCC patients after operation

Fudan University

Department of general surgery, Huashan hospital

laparoscopic hepatectomy for primary liver cancer

open hepatectomy for primary liver cancer

laparoscopic hepatectomy： laparoscopic hepatectomy for hepatocellular carcinoma.

lpaparoscopic hepatectomy

open hepatectomy: open hepatectomy for hepatocellular carcinoma

open hepatectomy

Zeng Li

Ye Lin

Li Zeng

This study was divided into laparoscopic hepatectomy (observation group) and laparoscopic hepatectomy (control group).Compared two groups of age, sex, body mass index (BMI), tumor diameter, number of tumors (single/multiple), pathologic characteristics, HBsAg (positive/negative), liver function, AFP, Child - Pugh, grading, nursing method and comparison of two groups of patients after surgery (surgical incision length, intraoperative blood, intraoperative blood transfusion and transfusion volume, operation time) the number of cases of and postoperative rehabilitation (death cases, for the first time the meal time, anus exhaust time, analgesic bed, first time, the abdominal cavity drainage tube time, length of hospital stay, postoperative days and liver function index.Follow-up: the survival rates of the two groups were compared in six months, one year, two years, three years and five years.In this study, the initial selection of the minimum sample size of 30 cases, plus 20% inefficiencies, the final initial selection of 36 cases, and the later expansion of the sample size of 100 cases.The research date starts on October 1, 2017.

Research design and methods:

This study was divided into laparoscopic hepatectomy (observation group) and laparoscopic hepatectomy (control group).Compared two groups of age, sex, body mass index (BMI), tumor diameter, number of tumors (single/multiple), pathologic characteristics, HBsAg (positive/negative), liver function, AFP, Child - Pugh, grading, nursing method and comparison of two groups of patients after surgery (surgical incision length, intraoperative blood, intraoperative blood transfusion and transfusion volume, operation time) the number of cases of and postoperative rehabilitation (death cases, for the first time the meal time, anus exhaust time, analgesic bed, first time, the abdominal cavity drainage tube time, length of hospital stay, postoperative days and liver function index.Follow-up: the survival rates of the two groups were compared in six months, one year, two years, three years and five years.In this study, the initial selection of the minimum sample size of 30 cases, plus 20% inefficiencies, the final initial selection of 36 cases, and the later expansion of the sample size of 100 cases.

Statistical methods: by means of SPSS 23.0 to analyze the data, all data after the normal test to choose the appropriate statistical methods, the normal distribution of measurement data in the two groups use surgery and postoperative recovery using two sets of samples t test, liver function index using analysis of variance, non-normal distribution using nonparametric test, count data chi-square test, P \< 0.05 for the difference was statistically significant.Survival analysis was performed on two groups of patients.The research date starts on October 1, 2017.

Nursing Fro Laparoscopic vs. Open Hepatectomy

Comparison of Efficacy and Nursing Between Laparoscopic Hepatectomy and Open Hepatectomy for Primary Liver Cancer

The incidence of complications, in percent

Compare the number of times to replace the drainage bag, unit: number

Number of subcutaneous injections Unit: times

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Laparoscopic Hepatectomy Versus Open Hepatectomy for PHC	NCT02014025	Primary Liver C...	Open hepatectom... Laparoscope hep...	18 Years - 70 Years	Southwest Hospital, China
Laparoscopic Versus Open Liver Resection for Hepatocellular Carcinoma	NCT02526043	Hepatocellular ...	laparoscopic he... Open hepatectom...	18 Years - 75 Years	Fudan University
Laparoscopic Versus Open Liver Resection for Hepatocellular Carcinoma	NCT02526043	Hepatocellular ...	laparoscopic he... Open hepatectom...	18 Years - 75 Years	Fudan University
Laparoscopic Hepatectomy Versus Open Hepatectomy for PHC	NCT02014025	Primary Liver C...	Open hepatectom... Laparoscope hep...	18 Years - 70 Years	Southwest Hospital, China
Nursing Fro Laparoscopic vs. Open Hepatectomy	NCT03585166	Liver Cancer Liver Neoplasms	lpaparoscopic h... open hepatectom...	18 Years -	Wuhan Union Hospital, China

Spots Global Cancer Trial Database for open hepatectomy