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Surgical resection is the most effective treatment of primary and secondary liver tumors. Technical innovations have mainly focused on minimizing bleeding during transection of the hepatic parenchyma because excessive hemorrhage and the need for blood transfusion are associated with increased postoperative morbidity and mortality. Recently,radiofrequency-assisted(RFA)hepatectomy has developed rapidly and gained widespread acceptance for the treatment of hepatocellular carcinomas(HCC),but its influence on the prognosis of HCC patients,especially for those with cirrhosis,is still controversial. Therefore, we design this prospective clinical trial to explore the effect of RFA hepatectomy versus the conventional hepatectomy on the outcomes of perioperative period and prognosis of HCC patients with cirrhosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| radiofrequency-assisted resection group(RF-R) | Experimental | Radiofrequency-assisted resection: separating the tumor from liver by using the probe of radiofrequency to block the arterial and vessels before parenchymal transection. |
|
| conventional liver resection group(CLR-R) | Active Comparator | Conventional liver resection group: hepatectomy only without RF assisted during parenchymal transection.Separating and dissecting the tumor with the routine clamp-crushing technical. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiofrequency-assisted Hepatectomy | Procedure | Radiofrequency-assisted resection: separating the tumor from liver by using the probe of radiofrequency to block the arterial and vessels before parenchymal transection. |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative liver injury | The degree of postoperative hepatic injury is assessed by daily measurements of postoperative aminotransferase (AST) and alanine aminotransferase (ALT) levels, serum bilirubin levels, and prothrombin times. Each patient is followed up within postoperative 90 days. | postoperative 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Adverse Events | It is evaluated according to the the Clavien-Dindo Classification of surgical complications. Postoperative mortality and morbidity are measured. | postoperative 90 days |
| Overall survival |
| Measure | Description | Time Frame |
|---|---|---|
| Blood parameter change after operation | Blood parameter change after operation is measured by postoperative blood routine test till the hospitalization. The estimated average postoperative hospitalization ranges from 10 ot 15 days (generally 2 weeks). If the incidence of postoperative hepatic insufficiency occurred beyond hospitalization,blood routine test is also necessarily counted in. | discharge from hospital (2 weeks) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rui Guo, Master of Medicine | Contact | 86-23-15922654727 | ruixx032@163.com | |
| Li Liu, MD | Contact | 86-23-68754374 | guor2006@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Xiaowu Li, MD-Ph D | Institute of hepatobiliry surgery,Southwest hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Hepatobiliry surgery,Southwest Hospital | Recruiting | Chongqing | Chongqing Municipality | 400038 | China |
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| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| D005355 | Fibrosis |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| Conventional Hepatectomy | Procedure | Hepatectomy was conducted without RF assisted during parenchymal transection. Separating and dissecting the tumor with the routine clamp-crushing technical. |
|
| 1,3,5-year overall survival |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |