Percutaneous Radiofrequency Ablation Versus Repeat Hepatectomy for Recurrent Hepatocellular Carcinoma

• ClinicalTrials.gov Identifier: NCT01570166
• Recruitment Status: Active, not recruiting
• First Posted: April 4, 2012
• Last Update Posted: June 26, 2019
• Sponsor: Sun Yat-sen University
• Information provided by (Responsible Party): Chen Min-Shan, Sun Yat-sen University

Study Description

Brief Summary:

Hepatocellular carcinoma (HCC) is the fifth most common cancer in the world. Partial hepatectomy is still considered as the conventional therapy for HCC. Intrahepatic recurrence of HCC after partial hepatectomy is common and was reported to be more than 77% within 5 years after surgery. Repeat hepatectomy is an effective treatment for intrahepatic HCC recurrence, with a 5-year survival rate of 19.4-56%. This is comparable to the survival after initial hepatectomy for HCC. Unfortunately, repeat hepatectomy could be carried out only in a small proportion of patients with HCC recurrence (10.4-31%), either because of the poor functional liver reserve or because of widespread intrahepatic recurrence. In the past two decades, percutaneous radiofrequency ablation (PRFA) has emerged as a new treatment modality and has attracted great interest because of its effectiveness and safety for small HCC (≤ 5.0 cm). Studies using PRFA to treat recurrent HCC after partial hepatectomy reported a 3-year survival rate of 62-68%, which is comparable to those achieved by surgery. PRFA is particularly suitable to treat recurrent HCC after partial hepatectomy because these tumors are usually detected when they are small and PRFA causes the least deterioration of liver function in the patients. To the best of our knowledge, there has been no report published in the medical literature comparing the efficacy of repeat hepatectomy with PRFA for recurrent HCC. The aim of this retrospective study is to compare the outcome of repeat hepatectomy with PRFA for small recurrent HCC after partial hepatectomy.

Condition or disease	Intervention/treatment	Phase
Hepatocellular Carcinoma	Procedure: HR; Procedure: RFA	Not Applicable

Detailed Description:

Hepatocellular carcinoma (HCC) is the fifth most common cancer in the world. Partial hepatectomy is still considered as the conventional therapy for HCC. Intrahepatic recurrence of HCC after partial hepatectomy is common and was reported to be more than 77% within 5 years after surgery. Repeat hepatectomy is an effective treatment for intrahepaticHCC recurrence, with a 5-year survival rate of 19.4-56%. This is comparable to the survival after initial hepatectomy for HCC. Unfortunately, repeat hepatectomy could be carried out only in a small proportion of patients with HCC recurrence (10.4-31%), either because of the poor functional liver reserve or because of widespread intrahepatic recurrence. In the past two decades, percutaneous radiofrequency ablation (PRFA) has emerged as a new treatment modality and has attracted great interest because of its effectiveness and safety for small HCC (≤ 5.0 cm). Studies using PRFA to treat recurrent HCC after partial hepatectomy reported a 3-year survival rate of 62-68%, which is comparable to those achieved by surgery. PRFA is particularly suitable to treat recurrent HCC after partial hepatectomy because these tumors are usually detected when they are small and PRFA causes the least deterioration of liver function in the patients. To the best of our knowledge, there has been no report published in the medical literature comparing the efficacy of repeat hepatectomy with PRFA for recurrent HCC. The aim of this retrospective study is to compare the outcome of repeat hepatectomy with PRFA for small recurrent HCC after partial hepatectomy.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 210 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Percutaneous Radiofrequency Ablation Versus Repeat Hepatectomy for Recurrent Hepatocellular Carcinoma
• Actual Study Start Date: November 1, 2011
• Actual Primary Completion Date: March 1, 2019
• Estimated Study Completion Date: March 1, 2023

Arms and Interventions

Arm	Intervention/treatment
Experimental: RFA; For RFA, 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.	Procedure: HR; HR 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.; Other Name: hepatic resection; surgical resection
Experimental: HR group; HR 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. Hemostasis of the raw liver surface was done with suturing and application of fibrin glue.	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.; Other Name: percutenous ablation

Outcome Measures

Primary Outcome Measures :

1. overall survival [ Time Frame: 5-year ]

Secondary Outcome Measures :

1. disease-free survival [ Time Frame: 5-year ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

1. age 18 - 75 years;
2. Distant recurrence of HCC after initial curative treatment (including initial RFA or hepatectomy);
3. no other treatment received except for the initial RFA or hepatectomy;
4. Single tumor less than 4cm in diameter;
5. lesions visible on ultrasound and with an acceptable and safe path between the lesion and the skin as shown on ultrasound;
6. no severe coagulation disorders (prothrombin activity < 40% or a platelet count of < 40,000 / mm3;
7. Eastern Co-operative Oncology Group performance(ECOG) status 0 -

Exclusion Criteria:

1. the presence of vascular invasion or extrahepatic spread on imaging;
2. a Child-Pugh class C liver cirrhosis or evidence of hepatic decompensation including ascites, severe coagulation disorders (prothrombin activity < 40% or a platelet count of < 40,000 / mm3), esophageal or gastric variceal bleeding or hepatic encephalopathy;
3. an American Society of Anesthesiologists (ASA) score ≥ 3

Contacts and Locations

Locations

China, Guangdong

Cancer Center, Sun Yat-set University

Guangzhou, Guangdong, China, 510060

Sponsors and Collaborators

Sun Yat-sen University

More Information

• Responsible Party: Chen Min-Shan, professor, Sun Yat-sen University
• ClinicalTrials.gov Identifier: NCT01570166
• Other Study ID Numbers: HCC16
• First Posted: April 4, 2012
• Last Update Posted: June 26, 2019
• Last Verified: June 2019

Keywords provided by Chen Min-Shan, Sun Yat-sen University:

Hepatocellular Carcinoma; RFA; HR

Additional relevant MeSH terms:

Carcinoma; Carcinoma, Hepatocellular; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Adenocarcinoma; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases