RALPPS Venus ALPPS for Hepatocellular Carcinoma

November 30, 2015 updated by: Yan Jun, Southwest Hospital, China

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.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Chongqing
      • Chongqing, Chongqing, China, 400038
        • Recruiting
        • Institute of hepatobiliary surgery,southwest hospital
        • Contact:
          • Jun Yan, Ph.D
          • Phone Number: +86-23-18502327600
          • Email: yanjun@sina.cn
        • Principal Investigator:
          • Jun Yan, Ph.D

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: ALPPS
Using ALPPS for the the treatment of hepatocellular carcinoma.
Procedure: ALPPS
Treat the hepatocellular carcinoma with ALPPS.
Experimental: RALPPS
Using radiofrequency ablation instead of in-situ split of liver in ALPPS stage I（RALPPS）.Habib 4X was used in RFA.
Procedure: RALPPS
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
morbidity during perioperation
Time Frame: 2 years
complications include bile leakage, abdominal infection, hemorrhage, PHLF e.t.
2 years
mortality during perioperation
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Southwest Hospital, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Anticipated)

November 1, 2016

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

November 17, 2014

First Submitted That Met QC Criteria

November 20, 2014

First Posted (Estimate)

November 24, 2014

Study Record Updates

Last Update Posted (Estimate)

December 2, 2015

Last Update Submitted That Met QC Criteria

November 30, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014KYNO.51

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hepatocellular Carcinoma

Clinical Trials on ALPPS

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in India

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe