Neoplasms

All Conditions

Digestive System Diseases

Carcinoma

Carcinoma, Hepatocellular

Liver Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Hematinics

All Drugs and Chemicals

Anti-Infective Agents

Central Nervous System Depressants

Antineoplastic Agents

Herbal and Botanical

Liver Extracts

Ethanol

Sorafenib

Protein Kinase Inhibitors

Enzyme Inhibitors

Anti-Infective Agents, Local

European Mistletoe

Progressive (deteriorate/Recurrence) or Death

Radiofrequency ablation

Trance-arterial chemoembolization

non-anatomical or anatomical liver resection

Liver resection

Combined radiofrequency ablation + percutaneous ethanol injection

Percutaneous ethanol injection

Systemic chemotherapy

Viscum

Symptomatic treatment

Emad A. Ahmed, MD, PhD

EASL and mRECIST criteria differ from each other in terms of the number of target lesions (all versus \< = 2) and calculation method (bidimensional versus unidimensional). Therefore, the investigators aimed to retrospectively analyze and compare the clinical outcomes among patients with hepatocellular carcinoma who were treated with different modalities of therapy according to the BCLC classification, and detect the possible predictors of post-treatment outcomes.

Background:

EASL and mRECIST criteria differ from each other in terms of the number of target lesions (all versus \< = 2) and calculation method (bidimensional versus unidimensional). Therefore, the investigators aimed to retrospectively analyze and compare the clinical outcomes among patients with hepatocellular carcinoma (HCC) who were treated with different modalities of therapy according to the BCLC classification, and detect the possible predictors of post-treatment outcomes.

Methods:

This work was conducted at the departments of tropical medicine and gastroenterology, internal medicine, and general surgery. This study included patients that matched our eligibility criteria for a period of five years started from June 2015 to May 2020. The study purpose was to retrospectively analyze the clinical outcomes among patients with HCC who were treated with different modalities of therapy according to the BCLC classification, and detect the possible predictors of post-treatment favorable outcomes. The data of the patients were extracted and retrospectively reviewed from the patients' records and the databases of both hospitals (SUH and SOI).

During the period of recruitment, 407 patients diagnosed with HCC admitted to our departments and followed-up attending outpatient clinics, Sohag University Hospitals, over a 5 years period.

Factors Affecting Post-treatment Outcomes in Patients With Hepatocellular Carcinoma

the HCC is treated (disappearance of all lesions)

increase in size - appearance of new intratumoral lesions - new lesions

Sohag University

Principal investigator

Symptoms and General Pathology

Liver Cirrhosis

percutaneous ablation of hepatocellular carcinoma

Franco Brunello, MD

Ethanol injection has been for many years the standard approach as percutaneous treatment of non-surgical early hepatocellular carcinoma in cirrhotic patients. Radiofrequency ablation has been proposed as an alternative approach and some retrospective and prospective comparative trials indicated its better performance for the local control of the disease in comparison to ethanol injection. Some prospective randomized studies from Japan and from Taiwan reported also an increase of overall survival in the patients treated by Radiofrequency. Aim of this study is to compare the two techniques in a prospective randomized trial in western patients.

Currently early hepatocellular carcinoma (HCC) complicating liver cirrhosis is often treated by percutaneous ablation techniques under ultrasound guidance: their performance is easy, safe and efficient. They are less invasive and expensive than surgical removal, representing a potential local cure for a larger number of patients than those who could be treated by a liver resection or offered a liver transplantation.

Percutaneous ethanol injection (PEI), the first non-surgical technique introduced in clinical practice, has been widely used since the late eighties. PEI induces a chemical and ischemic coagulative necrosis in 70-80% of small (\<3cm) HCC lesions. Necrosis obtained by this way is generally restricted to the neoplastic lesion itself; the chemical ablation may be moreover hampered by internal scars, that limit the uniform spreading of ethanol and by possible uncontrolled flows outside the lesion, with the ultimate result of a reduced necrotic effect and persistence of residual vital nests of neoplasia in as many as 33% of the cases. Nevertheless, the survival after PEI seems not different from surgery in retrospective series and this technique was indicated as the standard percutaneous treatment for early HCC in the 2001 guidelines of the European Association for the Study of the Liver (EASL).

In 1993 radio-frequency ablation (RF) was proposed as a new technique for the ablation of small HCCs. RF induces heat-generated coagulative necrosis of the neoplastic lesion and surrounding liver tissue. However, RF is not suitable for lesions situated close to large vessels or hollow viscera, as the first can decrease heat generation and the latter can be damaged by the procedure itself; it is more cumbersome, needs anaesthesiology assistance in most of the cases and, accordingly to early reports, is aggravated by a higher complication rate and higher costs. A major advantage of RF is the achievement of complete ablation of the neoplastic lesion with less sessions than PEI. This advantage impacts on the "quality of life" of the patient, who prefers to be cured in a single session rather than by the multisession approach of PEI.

When the present study began in January 2001, no randomised controlled trial comparing RF and PEI had been published and no data were available on mid-long term local tumor progression and on comparative survival rate after either treatment. Some retrospective studies about the primary effectiveness had been published.

The aim of our study was to compare the effectiveness of RF versus PEI in a randomised controlled trial: our primary end point was to evaluate the local control (sustained complete response) after 1 year from the treatment of every lesion defined as HCC in the single patient at the beginning of the trial; secondary end points included the primary effectiveness (early complete response)of the treatment after 1-2 months,the overall survival at four years, the complication rate, and the costs.

Comparison Between Radiofrequency Versus Ethanol Injection for the Treatment of Hepatocellular Carcinoma

Comparative Study Between Radiofrequency and Ethanol Injection for the Ablation of Small Hepatocellular Carcinoma Associated With Liver Cirrhosis

Azienda Ospedaliera San Giovanni Battista

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Factors Affecting Post-treatment Outcomes in Patients With Hepatocellular Carcinoma	NCT04553458	Hepatocellular ...	Radiofrequency ... Trance-arterial... Liver resection Combined radiof... Percutaneous et... Systemic chemot... Sorafenib Viscum Symptomatic tre...	18 Years -	Sohag University
Comparison Between Radiofrequency Versus Ethanol Injection for the Treatment of Hepatocellular Carcinoma	NCT00355212	Carcinoma, Hepa...	percutaneous ab...	0 Years -	Azienda Ospedaliera San Giovanni Battista
Factors Affecting Post-treatment Outcomes in Patients With Hepatocellular Carcinoma	NCT04553458	Hepatocellular ...	Radiofrequency ... Trance-arterial... Liver resection Combined radiof... Percutaneous et... Systemic chemot... Sorafenib Viscum Symptomatic tre...	18 Years -	Sohag University

Spots Global Cancer Trial Database for percutaneous ethanol injection