A Study of Laparoscopic Hepatectomy Versus RFA in the Treatment of Recurrent HCC
NCT ID: NCT03313648
Last Updated: 2017-10-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
180 participants
INTERVENTIONAL
2016-09-01
2021-09-01
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Laparoscopic Hepatectomy
Improvements in laparoscopic technology mean that LH now has superior short-term efficacy and similar long-term efficacy to open surgery , and LH has shown significant advantages in applications involving recurrent HCC.
Laparoscopic Hepatectomy
180 patients with recurrent HCC with recurrent nodular diameters of less than 5 cm and up to three nodules were randomly divided into LH (n=90) and RFA groups (n=90). Outcomes were monitored and evaluated during the 5-year follow-up period.
Radiofrequency Ablation
With recent technological advances, RFA has become the most widely investigated new first-line therapeutic option for recurrent HCCs . Numerous large studies have demonstrated the advantages of RFA, which include its ease of use, safety, effectiveness, minimal invasiveness, and minimal morbidity and mortality .
Radiofrequency Ablation
180 patients with recurrent HCC with recurrent nodular diameters of less than 5 cm and up to three nodules were randomly divided into LH (n=90) and RFA groups (n=90). Outcomes were monitored and evaluated during the 5-year follow-up period.
Interventions
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Laparoscopic Hepatectomy
180 patients with recurrent HCC with recurrent nodular diameters of less than 5 cm and up to three nodules were randomly divided into LH (n=90) and RFA groups (n=90). Outcomes were monitored and evaluated during the 5-year follow-up period.
Radiofrequency Ablation
180 patients with recurrent HCC with recurrent nodular diameters of less than 5 cm and up to three nodules were randomly divided into LH (n=90) and RFA groups (n=90). Outcomes were monitored and evaluated during the 5-year follow-up period.
Eligibility Criteria
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Inclusion Criteria
* 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.
* 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.
18 Years
70 Years
ALL
No
Sponsors
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Southwest Hospital, China
OTHER
Responsible Party
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Shuguo Zheng, MD
Professor of Institute of Hepatobiliary Surgery, Southwest Hospital, Third Military Medical University
Principal Investigators
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Shuguo Zheng
Role: STUDY_DIRECTOR
Shuguo Zheng, MD Study Director Institute of Hepatobiliary Surgery ,Southwest Hospital ,Third Military Medical University
Locations
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Southwest Hospital
Chongqing, Chongqing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Shuguo Zheng, M.D.
Role: primary
Other Identifiers
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SWHZSG007
Identifier Type: -
Identifier Source: org_study_id