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

Antineoplastic Agents

All Drugs and Chemicals

Pharmaceutical Solutions

Hematinics

Pembrolizumab

Doxorubicin

Liposomal doxorubicin

Chlorotrianisene

Liver Extracts

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Trans-arterial chemoembolization (TACE) using doxorubicin solution (60 mg dose) and gelatin sponge particles; followed, at least 30 or 45 days later, by pembrolizumab solution (200 mg dose) every 3 weeks for a maximum of 1 year

Doxorubicin injected through the hepatic blood supply directly to the cancer-affected part of the liver, then gelatin sponge particles injected to block the blood vessels supplying the tumour

Trans-arterial chemoembolization

Open label, single arm, multi-centre study of pembrolizumab following trans-arterial chemoembolization (TACE). Twenty-six to 32 evaluable participants with primary liver cancer (hepatocellular cancer; HCC) will be assessed. The primary objective is to determine the safety and tolerability of pembrolizumab following TACE. The secondary objective is to evaluate the efficacy of pembrolizumab following TACE by improving progression-free survival rates as measured by modified response evaluation criteria in solid tumours (mRECIST) criteria.

Study of Pembrolizumab Following TACE in Primary Liver Carcinoma

A Phase Ib Study of Pembrolizumab Following Trans-Arterial Chemoembolization in Primary Liver Carcinoma

The safety and tolerability of pembrolizumab will be assessed by recording the incidence of adverse events (AEs) using National Cancer Institute Common Terminology Criteria for Adverse Events version 4 (NCI CTCAE v4)

The efficacy of pembrolizumab following TACE will be measured by modified Response Evaluation Criteria In Solid Tumours (mRECIST) criteria.

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
Study of Pembrolizumab Following TACE in Primary Liver Carcinoma	NCT03397654	Primary Liver C...	Pembrolizumab Trans-arterial ...	18 Years -	Imperial College London
Laparoscopic Hepatectomy Versus Open Hepatectomy for PHC	NCT02014025	Primary Liver C...	Open hepatectom... Laparoscope hep...	18 Years - 70 Years	Southwest Hospital, China

Spots Global Cancer Trial Database for primary liver carcinoma