NCT02785380Not yet recruitingPhase 4
Laparoscopic Surgery VS RFA for Recurrent HCC
Laparoscopic Surgery Versus Radiofrequency Ablation for the Treatment of Recurrent Hepatocellular Carcinoma
Source: ClinicalTrials.gov · Last updated 2 Jun 2016 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Management of recurrent HCC is urgent and several treatments have been developed .Repeat hepatectomy is considered to be the first choice for recurrent HCC. Unfortunately, repeated open hepatectomy can be performed only in a small proportion of patients due to inadequate liver function reserve, widespread recurrence or high invasiveness. Given that recurrent tumors are usually detected at small size during follow-up after initial surgery, radiofreqency ablation (RFA), which is less invasive, may be locally curative and causes minimal damage to liver function reserve,has been widely used. However, the re-recurrence rate after RFA is more than 50%,and the recurrence-free survival is less than 20%. Recently, satisfactory short- and long-term oncological outcomes have been reported for laparoscopic surgery (LS) for the treatment for primary HCC with cirrhosis. Some single center pilot studies reported that LS may, compared with open surgery, improve the prognosis of HCC with less blood loss and shorter hospital stay. LS was initially considered not suitable for recurrent HCC due to postoperative adhesions that might make laparoscopic surgical procedure more difficult and less safe. With improvement in technique and experience, recent studies showed that LS for recurrent HCC in cirrhotic patients is a safe and feasible procedure with good short-term outcomes. However, thus far, no study has been performed to evaluate the long-term oncological outcomes of LS for recurrent HCC, and compare those results to that for RFA. To clarify these issues, a multicenter retrospective comparative study by using propensity score matching method that included a large consecutive series of patients with recurrent HCC within Milan criteria, who underwent LS or RFA, was performed.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 340 (estimated)
- First submitted
- 25 May 2016
- Start date
- Dec 2016
- Primary completion date
- Dec 2026
- Lead sponsor
- Sun Yat-sen University
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT02785380
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 340
- From Dec 2016 to the primary completion date, Dec 2026
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- History of hepatic encephalopathy, ascites refractory to diuretics or esophageal or gastric variceal bleeding;
- History of a secondary malignancy;
- Severe dysfunction of the heart, kidney, or other organs
Lab values
- Coagulation disorders (prothrombin activity \<40% or a platelet count of \<80,000/mm3);
Who the study is looking for
- Age 18-75 years;
- First recurrent HCC after curative hepatectomy;
- A solitary recurrent HCC ≤ 3.0 cm in diameter, or multiple recurrent HCC ≤ 3 lesions, each ≤ 3.0 cm in diameter;
- Tumor located in left lateral lobe (segment II or III) or subcapsule of liver(subcapsular nodule was defined as a lesion located less than 1 cm from the liver edge and could be treated by either LS or RFA.
- No radiologic evidence of invasion into major portal/ hepatic vein branches;
- No extrahepatic metastases;
- Child-Turcotte-Pugh class A or B;
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.