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A Study of Laparoscopic Hepatectomy Versus RFA in the Treatment of Recurrent HCC

Primary Purpose

Hepatocellular Carcinoma Recurrent

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Laparoscopic Hepatectomy
Radiofrequency Ablation
Sponsored by
Southwest Hospital, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma Recurrent focused on measuring Recurrent HCC, Laparoscopic Hepatectomy, RFA, RCT

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Any gender,18 to 70 years old;
  • Preoperative diagnosis of recurrent HCC clear,liver resection was done previously;
  • No active hepatitis and decompensated cirrhosis;
  • Patient with previous liver resection, maximum diameter ≤5cm single recurrent nodules or 3 nodules in diameter and no more than 3cm,did not infringe the portal vein,hepatic vein and inferior vena cava invasion,lymph node or extrahepatic turn;
  • No tumor rupture or bleeding;
  • Child-Pugh class A or B grade,ICG-R15 <20%;
  • No coagulation disorders,platelet count > 50 × 109 / L and prolonged prothrombin time < 5 seconds;
  • After diagnosis of recurrent HCC,not be including related surgery,radiofrequency ablation (RFA),TACE treatment,no certainty anticancer chemotherapy treatment;supreme absolute contraindications abdominal surgery;
  • Recurrent nodules are not close to intestines,stomach,cholecyst or diaphragm muscle, not close to the first porta hepatis,main vessel and biliary ducts;
  • Patients generally available,heart and lung function can tolerate surgery, abdominal surgery supreme absolute contraindications;
  • Voluntarily participate in the study, voluntarily accept any therapy of two,informed consent.

Exclusion Criteria:

  • Opposite of the above inclusion criteria;
  • Severe upper abdominal adhesions;
  • Postoperative pathological examination of the bile duct cell or mixed cell carcinoma and pathologically confirmed positive margin;
  • Foreign,Hong Kong,Macao,Taiwan and other regions,estimated postoperative difficult to track,followed up;
  • Nodules proved to be not recurrent HCC during intraoperative exploration, such as:liver metastases of colorectal cancer.

Sites / Locations

  • Southwest HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Laparoscopic Hepatectomy

Radiofrequency Ablation

Arm Description

Improvements in laparoscopic technology mean that LH now has superior short-term efficacy and similar long-term efficacy to open surgery , and LH has shown significant advantages in applications involving recurrent HCC.

With recent technological advances, RFA has become the most widely investigated new first-line therapeutic option for recurrent HCCs . Numerous large studies have demonstrated the advantages of RFA, which include its ease of use, safety, effectiveness, minimal invasiveness, and minimal morbidity and mortality .

Outcomes

Primary Outcome Measures

Survival rate
follow-up after the surgery every 3 months, to understand statistics 5-year survival.

Secondary Outcome Measures

intraoperative parameters
operation time and hepatic inflow occlusion time will be combined to report intraoperative parameters in hour(h).

Full Information

First Posted
October 5, 2017
Last Updated
October 13, 2017
Sponsor
Southwest Hospital, China
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1. Study Identification

Unique Protocol Identification Number
NCT03313648
Brief Title
A Study of Laparoscopic Hepatectomy Versus RFA in the Treatment of Recurrent HCC
Official Title
A RCT Study of Laparoscopic Hepatectomy Versus RFA in the Treatment of Recurrent HCC
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2016 (Actual)
Primary Completion Date
September 1, 2021 (Anticipated)
Study Completion Date
September 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Southwest Hospital, China

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To observe and compare the short-term and long-term oncological outcome of laparoscopic hepatectomy and radiofrequency ablation in the treatment of recurrent hepatocellular carcinoma .
Detailed Description
Background & Aims: Hepatocellular carcinoma (HCC) is the third leading cause of cancer-related death in the world. The 5-year recurrent rate of HCC after first curative resection is 77%~100%. Laparoscopic repeat liver resection (LRLR) has been shown in small retrospective studies to be a safe and effective treatment for recurrent hepatocellular carcinoma (rHCC) in selected patients, and radiofrequency ablation (RFA) has been increasingly performed for treating recurrent tumors involving the liver after hepatectomy. The aim of this study was to compare the short-term and long-term outcome of laparoscopic hepatectomy (LH) and radiofrequency ablation (RFA) in the treatment of rHCC.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma Recurrent
Keywords
Recurrent HCC, Laparoscopic Hepatectomy, RFA, RCT

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two different treatments are conducted on the participant base on the randomized choices
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Laparoscopic Hepatectomy
Arm Type
Experimental
Arm Description
Improvements in laparoscopic technology mean that LH now has superior short-term efficacy and similar long-term efficacy to open surgery , and LH has shown significant advantages in applications involving recurrent HCC.
Arm Title
Radiofrequency Ablation
Arm Type
Active Comparator
Arm Description
With recent technological advances, RFA has become the most widely investigated new first-line therapeutic option for recurrent HCCs . Numerous large studies have demonstrated the advantages of RFA, which include its ease of use, safety, effectiveness, minimal invasiveness, and minimal morbidity and mortality .
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic Hepatectomy
Intervention Description
180 patients with recurrent HCC with recurrent nodular diameters of less than 5 cm and up to three nodules were randomly divided into LH (n=90) and RFA groups (n=90). Outcomes were monitored and evaluated during the 5-year follow-up period.
Intervention Type
Procedure
Intervention Name(s)
Radiofrequency Ablation
Intervention Description
180 patients with recurrent HCC with recurrent nodular diameters of less than 5 cm and up to three nodules were randomly divided into LH (n=90) and RFA groups (n=90). Outcomes were monitored and evaluated during the 5-year follow-up period.
Primary Outcome Measure Information:
Title
Survival rate
Description
follow-up after the surgery every 3 months, to understand statistics 5-year survival.
Time Frame
5 years
Secondary Outcome Measure Information:
Title
intraoperative parameters
Description
operation time and hepatic inflow occlusion time will be combined to report intraoperative parameters in hour(h).
Time Frame
during the operation
Other Pre-specified Outcome Measures:
Title
postoperative complications
Description
hepatic failure,hemorrhage,biliary leakage,ascites,intra-abdominal infection,pleural effusion,pulmonary infection,cardiac insufficiency.
Time Frame
Duration hospitalization(an expected average of 7 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Any gender,18 to 70 years old; Preoperative diagnosis of recurrent HCC clear,liver resection was done previously; No active hepatitis and decompensated cirrhosis; Patient with previous liver resection, maximum diameter ≤5cm single recurrent nodules or 3 nodules in diameter and no more than 3cm,did not infringe the portal vein,hepatic vein and inferior vena cava invasion,lymph node or extrahepatic turn; No tumor rupture or bleeding; Child-Pugh class A or B grade,ICG-R15 <20%; No coagulation disorders,platelet count > 50 × 109 / L and prolonged prothrombin time < 5 seconds; After diagnosis of recurrent HCC,not be including related surgery,radiofrequency ablation (RFA),TACE treatment,no certainty anticancer chemotherapy treatment;supreme absolute contraindications abdominal surgery; Recurrent nodules are not close to intestines,stomach,cholecyst or diaphragm muscle, not close to the first porta hepatis,main vessel and biliary ducts; Patients generally available,heart and lung function can tolerate surgery, abdominal surgery supreme absolute contraindications; Voluntarily participate in the study, voluntarily accept any therapy of two,informed consent. Exclusion Criteria: Opposite of the above inclusion criteria; Severe upper abdominal adhesions; Postoperative pathological examination of the bile duct cell or mixed cell carcinoma and pathologically confirmed positive margin; Foreign,Hong Kong,Macao,Taiwan and other regions,estimated postoperative difficult to track,followed up; Nodules proved to be not recurrent HCC during intraoperative exploration, such as:liver metastases of colorectal cancer.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shuguo Zheng
Phone
0086-13508308676
Email
shuguozh@yahoo.com.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shuguo Zheng
Organizational Affiliation
Shuguo Zheng, MD Study Director Institute of Hepatobiliary Surgery ,Southwest Hospital ,Third Military Medical University
Official's Role
Study Director
Facility Information:
Facility Name
Southwest Hospital
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400038
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shuguo Zheng, M.D.
Phone
0086-13508308676
Email
shuguozh@yahoo.com.cn
First Name & Middle Initial & Last Name & Degree
Shuguo Zheng, M.D.

12. IPD Sharing Statement

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A Study of Laparoscopic Hepatectomy Versus RFA in the Treatment of Recurrent HCC

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