Southwest Hospital
Chongqing, Chongqing Municipality, 400038, China
NCT Number: NCT02014025
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㎝.
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Notify Me18 year–70 year
All sexes
Interventional
Not applicable
Chongqing, Chongqing Municipality, 400038, China
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:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
meet the criteria for Laparoscope hepatectomy group;
Exclusion criteria
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.
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.
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.
Time frame: during the operation
operation time, intraoperative blood loss, rate of blood transfusion, tumor resection margin.
Time frame: Duration hospitalization(an expected average of 7 days)
ascites, pleural effusion,cardiopulmonary insufficiency,mortality, postoperative liver function failure.
Shuguo Zheng, MD
Other
Laparoscopic Hepatectomy Versus Open Hepatectomy for PHC With a Tumor Size of 5-10cm:a Prospective Case-control Study
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