MedTrace Logo

Radiofrequency Ablation Versus Liver Resection for Elderly Patients With Hepatocellular Carcinoma (HCC) Within the Milan Criteria

NCT01570075 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2012-04-04

No results posted yet for this study

Summary

Hepatocellular carcinoma (HCC) is a common cancer, and it is the third commonest global cause of cancer-related death. With an increase in life-expectancy of the general population, the number of elderly with HCC is expected to increase. Current curative treatment options for HCC include: liver transplantation, liver resection (LR) and local ablation therapy. Liver transplantation is a good treatment for HCC within the Milan criteria (single HCC ≤ 5 cm or up to 3 nodules each \< 3 cm). As a consequence of the lack of liver donors, one relative contraindication for liver transplantation is age over 65 years, or the protocol requires elderly patients to have very good general health before they can be put on a transplant list. Transcatheter arterial chemoembolization (TACE) is used more commonly for the treatment of intermediate and advanced-staged HCC, while liver resection and local ablation therapy are used for early-staged HCC. Amongst the local ablative therapies, radiofrequency ablation (RFA) is most widely used. It has the advantage of minimally invasiveness, making it the first-line treatment for small HCC in patients with compromised liver function or associated severe medical conditions.

Elderly patients are more likely to have poor general conditions and associated medical diseases. RFA has the advantage of being less invasive and it causes less pain, less blood loss and earlier recovery than LR. On the other hand, incomplete ablation of HCC and tumor track seeding may happen. Several studies have demonstrated the safety of LR for elderly patients. There is no good evidence in the medical literature to support whether RFA or LR is a better treatment for elderly patients with HCC.

Conditions

Interventions

PROCEDURE

HR

SR was carried out under general anesthesia using a right subcostal incision with a midline extension. Intra-operative ultrasonography was performed routinely to evaluate the tumor burden, liver remnant, and the possibility of a negative resection margin. Anatomic resection, in the form of segmentectomy and/or subsegmentectomy as described by Makuuchi et al. (16) was the preferred surgical method of liver resection. Pringle's maneuver was routinely used with a clamp and unclamp time of 10 min and 5 min, respectively; this technique was used repeatedly throughout the entire procedure.

PROCEDURE

RFA

For PRFA, we used a commercially available system with a 375-KHz computer-assisted radiofrequency generator (Elektrotom HiTT 106, Berchtold, Medizinelektronik, Germany) and an open-perfused electrode (Berchtold, Tuttlingen, Germany) of 15 cm (or 20 cm), 14 Ga, and a 15 mm (or 20 mm) active electrode tip with microbores.

Sponsors & Collaborators

  • Sun Yat-sen University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
65 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2014-07-31
Completion
2015-07-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01570075 on ClinicalTrials.gov