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Laparoscopic Surgery VS RFA for Recurrent HCC

Primary Purpose

Hepatocellular Carcinoma

Status
Not yet recruiting
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

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age 18-75 years;
  2. First recurrent HCC after curative hepatectomy;
  3. A solitary recurrent HCC ≤ 3.0 cm in diameter, or multiple recurrent HCC ≤ 3 lesions, each ≤ 3.0 cm in diameter;
  4. 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.
  5. No radiologic evidence of invasion into major portal/ hepatic vein branches;
  6. No extrahepatic metastases;
  7. Child-Turcotte-Pugh class A or B;

Exclusion Criteria:

  1. Coagulation disorders (prothrombin activity <40% or a platelet count of <80,000/mm3);
  2. History of hepatic encephalopathy, ascites refractory to diuretics or esophageal or gastric variceal bleeding;
  3. History of a secondary malignancy;
  4. 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)

    Radiofrequency ablation(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.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.

    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).

    Outcomes

    Primary Outcome Measures

    Overall survival

    Secondary Outcome Measures

    Recurrence-free survival

    Full Information

    First Posted
    May 25, 2016
    Last Updated
    June 1, 2016
    Sponsor
    Sun Yat-sen University
    Collaborators
    Second Military Medical University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02785380
    Brief Title
    Laparoscopic Surgery VS RFA for Recurrent HCC
    Official Title
    Laparoscopic Surgery Versus Radiofrequency Ablation for the Treatment of Recurrent Hepatocellular Carcinoma
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2016
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 2016 (undefined)
    Primary Completion Date
    December 2026 (Anticipated)
    Study Completion Date
    December 2026 (Anticipated)

    3. Sponsor/Collaborators

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

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    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
    340 (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.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.
    Arm Title
    Radiofrequency ablation(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 by using a commercially available Cool-tipTM RFA system (Valleylab, Boulder, CO, USA), or a RF 2000 system (Radio-Therapeutics Mountain View, CA).
    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
    Other Pre-specified Outcome Measures:
    Title
    Number of Participants With Treatment-Related Adverse Events as Assessed by
    Time Frame
    1 month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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; Exclusion Criteria: 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Zhen-Wei Peng, Ph.D.
    Phone
    862087755766
    Ext
    8576
    Email
    pengzhenwei2005@163.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ming Kuang, Ph.D.
    Phone
    862087755766
    Ext
    8576
    Email
    pengzhenwei2005@163.com
    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
    15868653
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    10024103
    Citation
    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.
    Results Reference
    background

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    Laparoscopic Surgery VS RFA for Recurrent HCC

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