Radiofrequency Ablation in Treating Patients With Liver Cancer (Hepatocellular Carcinoma)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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Recruitment Status : Withdrawn (Lack of referrals.)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 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01669668
|Principal Investigator:||Steven Strasberg, M.D.||Washington University School of Medicine|