Radiofrequency Ablation in Treating Patients With Liver Cancer (Hepatocellular Carcinoma)
|ClinicalTrials.gov Identifier: NCT01669668|
Recruitment Status : Withdrawn (Lack of referrals.)
First Posted : August 21, 2012
Last Update Posted : July 16, 2014
|Condition or disease||Intervention/treatment||Phase|
|Carcinoma, Hepatocellular||Procedure: radiofrequency ablation Procedure: laparoscopy||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Radiofrequency Ablation Under Ideal Conditions in Hepatocellular Carcinoma|
|Study Start Date :||December 2014|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2018|
Patients undergo laparoscopic ultrasound followed by RFA.
Procedure: radiofrequency ablation
Undergo RFAProcedure: laparoscopy
Undergo laparoscopic ultrasound
- Local recurrence, defined as the recurrence at the size of original tumor [ Time Frame: Up to 2 years ]Local recurrence will be summarized using descriptive statistics.
- Morbidity and mortality associated with RFA under ideal conditions [ Time Frame: 30 days ]The incidences of surgical complications and procedure-related death will be calculated.
- Overall survival rate [ Time Frame: At 2 years ]Kaplan-Meier product limit method will be used to estimate the 2-year overall survival. The median overall survival will also be
- Disease-free survival rate [ Time Frame: At 2 years ]Kaplan-Meier product limit method will be used to estimate the 2-year disease-free survival. The median disease-free survival will also be estimated.
- Ability of patients who develop recurrence to undergo salvage transplantation [ Time Frame: Up to 2 years ]At the time of recurrence, the patient is evaluated to see if she/he falls within the Milan criteria; if she/he does, then she/he is considered able to undergo salvage transplantation.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01669668
|Principal Investigator:||Steven Strasberg, M.D.||Washington University School of Medicine|