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Laparoscopic Surgery Versus Radiofrequency Ablation for Recurrent HCC

Primary Purpose

Hepatocellular Carcinoma

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Laparoscopic Surgery(LS)
RFA
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)Does not accept healthy volunteers

Inclusion Criteria:

  1. age 18-75 years;
  2. recurrent HCC after curative partial hepatectomy;
  3. no other treatment received except for partial hepatectomy;
  4. a solitary recurrent HCC ≤ 5.0 cm in diameter, or multiple recurrent HCC ≤ 3 lesions, each ≤ 3.0 cm in diameter;
  5. no radiologic evidence of invasion into major portal/ hepatic vein branches ;
  6. no extrahepatic metastases;
  7. Child-pugh class A or B liver cirrhosis;
  8. American Society of Anesthesiologists (ASA) score ≤ 3;
  9. Eastern Co-operative Oncology Group performance (ECOG) status 0;

Exclusion Criteria:

  1. coagulation disorders (prothrombin activity <40% or a platelet count of <80,000/mm3);
  2. Child-Pugh class C liver cirrhosis;
  3. history of hepatic encephalopathy, ascites refractory to diuretics or esophageal or gastric variceal bleeding;
  4. a history of a secondary malignancy;
  5. active infection (except viral hepatitis);
  6. severe dysfunction of the heart, kidney, or other organs

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Laparoscopic Surgery(LS)

    RFA

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Overall survival

    Secondary Outcome Measures

    Recurrence-free survival
    Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0

    Full Information

    First Posted
    August 24, 2015
    Last Updated
    August 25, 2015
    Sponsor
    Sun Yat-sen University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02535117
    Brief Title
    Laparoscopic Surgery Versus Radiofrequency Ablation for Recurrent HCC
    Official Title
    Laparoscopic Surgery Versus Radiofrequency Ablation for Recurrent Hepatocellular Carcinoma After Initial Partial Hepatectomy: A Multicenter Experience
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2015
    Overall Recruitment Status
    Unknown status
    Study Start Date
    June 2015 (undefined)
    Primary Completion Date
    July 2018 (Anticipated)
    Study Completion Date
    July 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Sun Yat-sen University

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Hepatocellular carcinoma (HCC) is the fifth most common and the third leading cause of death from cancer worldwide1 . Hepatectomy is still the main effective treatment for HCC accompanying with well-preserved cirrhosis when liver transplantation is not feasible due to the lack of donors Recurrence of tumor within the liver remnant is also common, with a reported 5-year recurrence rate of 50-70%, in patients who have undergone "curative" hepatectomy. Management of recurrent HCC is still urgent and several treatments have been developed. Repeat hepatectomy is considered to be the first choice for recurrent HCC with a 5-year survival rate of 19.4 to 56%. Unfortunately, repeat hepatectomy can be performed only in a small proportion of patients with HCC recurrence due to the poor functional liver reserve or because of widespread recurrence. With a 3-year survival rate of 62% to 68% after treatment, radiofreqency ablation (RFA) has been used as an effective treatment for recurrent HCC. The efficacy of RFA for recurrent HCC has been reported to be comparable to those achieved by surgery. Laparoscopic surgery was considered not to be a suitable treatment for recurrent HCC due to postoperative adhesions that can make laparoscopic surgical procedure more difficult and less safe. Recently, several studies reported that laparoscopic surgery for recurrent HCC in cirrhotic patients is a safe and feasible procedure with good short-term outcomes. By far, no study has been performed to compare the efficacy and safety of laparoscopic surgery with RFA for treatment of recurrent HCC.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hepatocellular Carcinoma

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    216 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Laparoscopic Surgery(LS)
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    RFA
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Procedure
    Intervention Name(s)
    Laparoscopic Surgery(LS)
    Intervention Description
    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.
    Intervention Type
    Procedure
    Intervention Name(s)
    RFA
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Overall survival
    Time Frame
    5 years
    Secondary Outcome Measure Information:
    Title
    Recurrence-free survival
    Time Frame
    5 years
    Title
    Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0
    Time Frame
    1 month

    10. Eligibility

    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: age 18-75 years; recurrent HCC after curative partial hepatectomy; no other treatment received except for partial hepatectomy; a solitary recurrent HCC ≤ 5.0 cm in diameter, or multiple recurrent HCC ≤ 3 lesions, each ≤ 3.0 cm in diameter; no radiologic evidence of invasion into major portal/ hepatic vein branches ; no extrahepatic metastases; Child-pugh class A or B liver cirrhosis; American Society of Anesthesiologists (ASA) score ≤ 3; Eastern Co-operative Oncology Group performance (ECOG) status 0; Exclusion Criteria: coagulation disorders (prothrombin activity <40% or a platelet count of <80,000/mm3); Child-Pugh class C liver cirrhosis; history of hepatic encephalopathy, ascites refractory to diuretics or esophageal or gastric variceal bleeding; a history of a secondary malignancy; active infection (except viral hepatitis); severe dysfunction of the heart, kidney, or other organs
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ming Kuang, Ph.D.
    Organizational Affiliation
    First Affiliated Hospital, Sun Yat-Sen University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    17705086
    Citation
    Belli G, Fantini C, D'Agostino A, Cioffi L, Langella S, Russolillo N, Belli A. Laparoscopic versus open liver resection for hepatocellular carcinoma in patients with histologically proven cirrhosis: short- and middle-term results. Surg Endosc. 2007 Nov;21(11):2004-11. doi: 10.1007/s00464-007-9503-6. Epub 2007 Aug 19.
    Results Reference
    background
    PubMed Identifier
    22157201
    Citation
    Peng ZW, Zhang YJ, Liang HH, Lin XJ, Guo RP, Chen MS. Recurrent hepatocellular carcinoma treated with sequential transcatheter arterial chemoembolization and RF ablation versus RF ablation alone: a prospective randomized trial. Radiology. 2012 Feb;262(2):689-700. doi: 10.1148/radiol.11110637. Epub 2011 Dec 12.
    Results Reference
    background

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    Laparoscopic Surgery Versus Radiofrequency Ablation for Recurrent HCC

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