Status:
UNKNOWN
A Study of Laparoscopic Hepatectomy Versus RFA in the Treatment of Recurrent HCC
Lead Sponsor:
Southwest Hospital, China
Conditions:
Hepatocellular Carcinoma Recurrent
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
To observe and compare the short-term and long-term oncological outcome of laparoscopic hepatectomy and radiofrequency ablation in the treatment of recurrent hepatocellular carcinoma .
Detailed Description
Background \& Aims: Hepatocellular carcinoma (HCC) is the third leading cause of cancer-related death in the world. The 5-year recurrent rate of HCC after first curative resection is 77%\~100%. Laparo...
Eligibility Criteria
Inclusion
- Any gender,18 to 70 years old;
- Preoperative diagnosis of recurrent HCC clear,liver resection was done previously;
- No active hepatitis and decompensated cirrhosis;
- Patient with previous liver resection, maximum diameter ≤5cm single recurrent nodules or 3 nodules in diameter and no more than 3cm,did not infringe the portal vein,hepatic vein and inferior vena cava invasion,lymph node or extrahepatic turn;
- No tumor rupture or bleeding;
- Child-Pugh class A or B grade,ICG-R15 \<20%;
- No coagulation disorders,platelet count \> 50 × 109 / L and prolonged prothrombin time \< 5 seconds;
- After diagnosis of recurrent HCC,not be including related surgery,radiofrequency ablation (RFA),TACE treatment,no certainty anticancer chemotherapy treatment;supreme absolute contraindications abdominal surgery;
- Recurrent nodules are not close to intestines,stomach,cholecyst or diaphragm muscle, not close to the first porta hepatis,main vessel and biliary ducts;
- Patients generally available,heart and lung function can tolerate surgery, abdominal surgery supreme absolute contraindications;
- Voluntarily participate in the study, voluntarily accept any therapy of two,informed consent.
Exclusion
- Opposite of the above inclusion criteria;
- Severe upper abdominal adhesions;
- Postoperative pathological examination of the bile duct cell or mixed cell carcinoma and pathologically confirmed positive margin;
- Foreign,Hong Kong,Macao,Taiwan and other regions,estimated postoperative difficult to track,followed up;
- Nodules proved to be not recurrent HCC during intraoperative exploration, such as:liver metastases of colorectal cancer.
Key Trial Info
Start Date :
September 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2021
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT03313648
Start Date
September 1 2016
End Date
September 1 2021
Last Update
October 18 2017
Active Locations (1)
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1
Southwest Hospital
Chongqing, Chongqing Municipality, China, 400038