Laparoscopic Surgery VS RFA for Recurrent HCC

NCT02785380 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: HCC007
• Study Type: interventional
• Target: 340
• Locations: 0 countries
• Sites: N/A

Brief Summary

Management of recurrent HCC is urgent and several treatments have been developed .Repeat hepatectomy is considered to be the first choice for recurrent HCC. Unfortunately, repeated open hepatectomy can be performed only in a small proportion of patients due to inadequate liver function reserve, widespread recurrence or high invasiveness. Given that recurrent tumors are usually detected at small size during follow-up after initial surgery, radiofreqency ablation (RFA), which is less invasive, may be locally curative and causes minimal damage to liver function reserve,has been widely used. However, the re-recurrence rate after RFA is more than 50%,and the recurrence-free survival is less than 20%. Recently, satisfactory short- and long-term oncological outcomes have been reported for laparoscopic surgery (LS) for the treatment for primary HCC with cirrhosis. Some single center pilot studies reported that LS may, compared with open surgery, improve the prognosis of HCC with less blood loss and shorter hospital stay. LS was initially considered not suitable for recurrent HCC due to postoperative adhesions that might make laparoscopic surgical procedure more difficult and less safe. With improvement in technique and experience, recent studies showed that LS for recurrent HCC in cirrhotic patients is a safe and feasible procedure with good short-term outcomes. However, thus far, no study has been performed to evaluate the long-term oncological outcomes of LS for recurrent HCC, and compare those results to that for RFA. To clarify these issues, a multicenter retrospective comparative study by using propensity score matching method that included a large consecutive series of patients with recurrent HCC within Milan criteria, who underwent LS or RFA, was performed.

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

• Overall survival

  5 years

Secondary Outcomes (1)

• Recurrence-free survival

  5 years

Other Outcomes (1)

• Number of Participants With Treatment-Related Adverse Events as Assessed by

  1 month

Study Arms (2)

laparoscopic surgery(LS)

EXPERIMENTAL

For LS,the patient was usually placed in the lithotomy position. Pneumoperitoneum was maintained at a pressure between 12 and 14 mmHg.Intra-operative ultrasonography was performed routinely. Large bile duct branches or vessels were clipped before division and minor hemostasis was carried out using bipolar diathermy. Large hepatic vein branches were divided by endovascular staplers. The Pringle maneuver was not used. Wedge resection, segmentectomy or subsegmentectomy was performed. The surgeon aimed to achieve a 1.0-cm safety margin during the liver resection.

Procedure: laparoscopic surgery(LS)

Radiofrequency ablation(RFA)

ACTIVE COMPARATOR

RFA was performed according to the Guidelines of Radiofrequency Ablation Therapy for Liver Cancer: Chinese Expert Consensus Statement issued by the Chinese Society of Liver Cancer and Chinese Society of Clinical Oncology. RFA was performed by using a commercially available Cool-tipTM RFA system (Valleylab, Boulder, CO, USA), or a RF 2000 system (Radio-Therapeutics Mountain View, CA).

Procedure: RFA

Interventions

laparoscopic surgery(LS) PROCEDURE

For LS, the patient was usually placed in the lithotomy position. Pneumoperitoneum was maintained at a pressure between 12 and 14 mmHg. Three to 4 working ports sized between 5 mm and 12 mm were used . Intra-operative ultrasonography was performed routinely. Parenchymal transection was performed using a Cavitron ultrasonic surgical aspirator (CUSA, Valleylab, Boulder, CO, USA). Large bile duct branches or vessels were clipped before division and minor hemostasis was carried out using bipolar diathermy. Large hepatic vein branches were divided by endovascular staplers. A 1.0-cm safety margin was planed to get during the liver resection.

laparoscopic surgery(LS)

RFA PROCEDURE

RFA was performed according to the Guidelines of Radiofrequency Ablation Therapy for Liver Cancer: Chinese Expert Consensus Statement issued by the Chinese Society of Liver Cancer and Chinese Society of Clinical Oncology RFA was performed under real-time ultrasound guidance. RFA was performed by using a commercially available Cool-tipTM RFA system (Valleylab, Boulder, CO, USA), or a RF 2000 system (Radio-Therapeutics Mountain View, CA). Grounding was achieved by attaching 2 pads to the patient's back or legs.

Radiofrequency ablation(RFA)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-75 years;
• First recurrent HCC after curative hepatectomy;
• A solitary recurrent HCC ≤ 3.0 cm in diameter, or multiple recurrent HCC ≤ 3 lesions, each ≤ 3.0 cm in diameter;
• Tumor located in left lateral lobe (segment II or III) or subcapsule of liver(subcapsular nodule was defined as a lesion located less than 1 cm from the liver edge and could be treated by either LS or RFA.
• No radiologic evidence of invasion into major portal/ hepatic vein branches;
• No extrahepatic metastases;
• Child-Turcotte-Pugh class A or B;

You may not qualify if:

• Coagulation disorders (prothrombin activity \<40% or a platelet count of \<80,000/mm3);
• History of hepatic encephalopathy, ascites refractory to diuretics or esophageal or gastric variceal bleeding;
• History of a secondary malignancy;
• Severe dysfunction of the heart, kidney, or other organs

Sponsors & Collaborators

• Sun Yat-sen University: lead
• Second Military Medical University: collaborator

Related Publications (2)

• Camma C, Di Marco V, Orlando A, Sandonato L, Casaril A, Parisi P, Alizzi S, Sciarrino E, Virdone R, Pardo S, Di Bona D, Licata A, Latteri F, Cabibbo G, Montalto G, Latteri MA, Nicoli N, Craxi A; Unita Interdipartimentale Neoplasie Epatiche (U.I.N.E) Group. Treatment of hepatocellular carcinoma in compensated cirrhosis with radio-frequency thermal ablation (RFTA): a prospective study. J Hepatol. 2005 Apr;42(4):535-40. doi: 10.1016/j.jhep.2004.11.042.

  PMID: 15868653 BACKGROUND

• Poon RT, Fan ST, Lo CM, Liu CL, Wong J. Intrahepatic recurrence after curative resection of hepatocellular carcinoma: long-term results of treatment and prognostic factors. Ann Surg. 1999 Feb;229(2):216-22. doi: 10.1097/00000658-199902000-00009.

  PMID: 10024103 BACKGROUND

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Laparoscopy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Ming Kuang, Ph.D.

  First Affiliated Hospital, Sun Yat-Sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhen-Wei Peng, Ph.D.

CONTACT

862087755766; pengzhenwei2005@163.com

Ming Kuang, Ph.D.

CONTACT

862087755766; pengzhenwei2005@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.D.,M.D.

Study Record Dates

• First Submitted: May 25, 2016
• First Posted: May 27, 2016
• Study Start: December 1, 2016
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 2, 2016

Record last verified: 2016-06