RALPPS Venus ALPPS for Hepatocellular Carcinoma
Primary Purpose
Hepatocellular Carcinoma
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
RALPPS
ALPPS
Sponsored by
About this trial
This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring RFA, ALPPS, hepatectomy, morbidity and mortality
Eligibility Criteria
Inclusion Criteria:
- An insufficient future liver remnant(FLR<30% in normal hepatic function or FLR<40% with hepatic cirrhosis or after chemotherapy)
- Liver function of Child-Pugh Class A or B.
- Liver Reserve Function:ICG-R15≤10%
- No evidence of coagulopathy: platelet count > 50 × 109/L and a prolonged prothrombin time of < 5 seconds.
Exclusion Criteria:
- Patients met the inclusion criteria but declined to participate.
- Patients with severe portal hypertension, a history of esophageal variceal hemorrhage, severe hypersplenism syndrome, or refractory ascites.
- Main portal vein、inferior vena cava、common hepatic duct and hepatic vein have tumor thrombus.
- Extrahepatic or lymph node metastasis
Sites / Locations
- Institute of hepatobiliary surgery,Southwest HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
ALPPS
RALPPS
Arm Description
Using ALPPS for the the treatment of hepatocellular carcinoma.
Using radiofrequency ablation instead of in-situ split of liver in ALPPS stage I(RALPPS).Habib 4X was used in RFA.
Outcomes
Primary Outcome Measures
morbidity during perioperation
complications include bile leakage, abdominal infection, hemorrhage, PHLF e.t.
mortality during perioperation
Secondary Outcome Measures
Full Information
NCT ID
NCT02299843
First Posted
November 17, 2014
Last Updated
November 30, 2015
Sponsor
Southwest Hospital, China
1. Study Identification
Unique Protocol Identification Number
NCT02299843
Brief Title
RALPPS Venus ALPPS for Hepatocellular Carcinoma
Official Title
A Prospective Randomized Controlled Trial of Radio-frequency Assisted ALPPS(RALPPS)and Associating Liver Partition and Portal Vein Ligation for Staged Hepatectomy(ALPPS)in the Treatment of Hepatocellular Carcinoma.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2015
Overall Recruitment Status
Unknown status
Study Start Date
October 2014 (undefined)
Primary Completion Date
November 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Southwest Hospital, China
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Currently,the "ALPPS" (associating liver partition with portal vein ligation for staged hepatectomy) procedure which enables the rapid growth of the future liver remnant and extends surgical indication to patients with mid-advanced stage hepatocellular carcinoma becomes a research hot spot. However, the procedure has a high morbidity and mortality rate.Using radio-frequency ablation instead of in-situ split of liver to avoid forming a coagulation band in stage I will reduce the incidence of complications(bile leakage, abdominal infection,hemorrhage e.t.) The investigators named this technique as Radio-frequency Assisted Liver Partition with Portal vein ligation for staged hepatectomy (RALPPS).Investigators hypothesized that the RALPPS might result in lower morbidity and mortality rate than ALPPS in the treatment of hepatocellular carcinoma . This Prospective Randomized Controlled Trial is on the Safety and Efficacy of radio-frequency assisted liver partition with portal vein ligation for staged hepatectomy for hepatocellular carcinoma.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
Keywords
RFA, ALPPS, hepatectomy, morbidity and mortality
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
32 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ALPPS
Arm Type
Active Comparator
Arm Description
Using ALPPS for the the treatment of hepatocellular carcinoma.
Arm Title
RALPPS
Arm Type
Experimental
Arm Description
Using radiofrequency ablation instead of in-situ split of liver in ALPPS stage I(RALPPS).Habib 4X was used in RFA.
Intervention Type
Procedure
Intervention Name(s)
RALPPS
Intervention Description
Using radiofrequency ablation assisted ALPPS(RALPPS)instead of in-situ split of liver to form a coagulation band in stage I.Habib 4X was used in RFA.
Intervention Type
Procedure
Intervention Name(s)
ALPPS
Intervention Description
Treat the hepatocellular carcinoma with ALPPS.
Primary Outcome Measure Information:
Title
morbidity during perioperation
Description
complications include bile leakage, abdominal infection, hemorrhage, PHLF e.t.
Time Frame
2 years
Title
mortality during perioperation
Time Frame
2 years
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:
An insufficient future liver remnant(FLR<30% in normal hepatic function or FLR<40% with hepatic cirrhosis or after chemotherapy)
Liver function of Child-Pugh Class A or B.
Liver Reserve Function:ICG-R15≤10%
No evidence of coagulopathy: platelet count > 50 × 109/L and a prolonged prothrombin time of < 5 seconds.
Exclusion Criteria:
Patients met the inclusion criteria but declined to participate.
Patients with severe portal hypertension, a history of esophageal variceal hemorrhage, severe hypersplenism syndrome, or refractory ascites.
Main portal vein、inferior vena cava、common hepatic duct and hepatic vein have tumor thrombus.
Extrahepatic or lymph node metastasis
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jun Yan, Ph.D
Phone
+86-23-18502327600
Email
yanjun@sina.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kuansheng Ma, Ph.D
Organizational Affiliation
Institute of hepatobiliary surgery,Southwest Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Institute of hepatobiliary surgery,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
Jun Yan, Ph.D
Phone
+86-23-18502327600
Email
yanjun@sina.cn
First Name & Middle Initial & Last Name & Degree
Jun Yan, Ph.D
12. IPD Sharing Statement
Learn more about this trial
RALPPS Venus ALPPS for Hepatocellular Carcinoma
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