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The study, entitled "RCT study of laparoscopic middle hepatic venous guidance versus conventional ananatomical hemihepatectomy", was designed to compare the efficacy of two different ananatomical hemihepatectomy procedures under laparoscopy.
Backgroud & Aim:Hepatectomy is the main way to treat all kinds of liver surgical diseases, which can be divided into anatomic hepatectomy and non-anatomic hepatectomy.Among them, anatomic hepatectomy is suitable for primary liver cancer, hepatolithiasis and other benign and malignant diseases;It can be divided into hepatic venous guidance and non-hepatic venous guidance hepatectomy (traditional ananatomical hepatectomy).The aim of this study was to observe and compare the perioperative period and follow-up results of the two different laparoscopic surgical resection methods, and to provide high-level evidence-based medicine evidence for the selection of surgical methods for laparoscopic anatomical hemihepatectomy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| laparoscopic middle hepatic vein guidance hemihepatectomy | Experimental | In theory, the advantages of anatomical hemihepatectomy guided by middle hepatic vein are as follows: 1) correctly guiding the transecting plane of the liver parenchyma can reduce the cross-sectional area of the liver and avoid damaging the vascular ducts of the pre-cut liver. so as to reduce the residue of necrotic tissue without blood supply and reduce the occurrence of postoperative complications. 2) active anatomy and exposure of hepatic vein can avoid uncontrollable bleeding after passive injury of hepatic vein, and laparoscopic anatomy has obvious advantage in exposing hepatic vein. 3) it may reduce the early recurrence rate of hepatocellular carcinoma after operation. |
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| laparoscopic traditional anatomic hemihepatectomy | Active Comparator | According to textbooks and the views of some scholars at present, traditional anatomical hepatectomy (non-hepatic vein-guided anatomical hepatectomy) has the following advantages: 1) avoiding exposure of hepatic vein can reduce the probability of injury to the trunk of hepatic vein, thus reduce the risk of massive bleeding during operation; 2) the difficulty of operation is relatively low, and a better short-term and long-term effect can be obtained. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| laparoscopic middle hepatic vein guidance anatomic hemihepatectomy | Procedure | 95 patients with primary HCC were divided into the middle hepatic vein guidance group(n=45) and the traditional group(n=45) according to the odd and even Numbers, and sealed into envelopes.Outcomes were monitored and evaluated during the 3-year follow-up period |
| Measure | Description | Time Frame |
|---|---|---|
| Survival rate | follow-up after the surgery every 3 months, to understand statistics 1-year overall survival、3-year overall survival、1-year disease-free survival、3-year disease-free survival | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Perioperative results | the angle of hepatic vein between segment Ⅳ b and Ⅴ, angle between MHV and IVC | Duration perioperation(an expected average of 3 days) |
| intraoperative parameters | blood loss per unit area will be combined to report intraoperative parameters in milliliter/square centimetre(ml/c㎡) |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of postoperative complications | hemorrhage,biliary leakage,ascites,intra-abdominal infection,pleural effusion,pulmonary infection,cardiopulmonary insufficiency,liver function failure | Duration hospitalization(an expected average of 7 days) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shuguo Zheng, M.D. | Contact | 0086-13508308676 | shuguozh@yahoo.com.cn | |
| Shuguo Zheng, Zheng | Contact | 0086-13508308676 | shuguozh@yahoo.com.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southwest Hospital | Recruiting | Chongqing | Chongqing Municipality | 400038 | China |
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| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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Two different treatments are conducted on the participant base on the randomized choices
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| during the operation |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |