RALPPS Venus ALPPS for Hepatocellular Carcinoma

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.

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02299843

Enrollment

Registered

2014-11-24

Start date

2014-10-31

Completion date

2016-12-31

Last updated

2015-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatocellular Carcinoma

Keywords

RFA, ALPPS, hepatectomy, morbidity and mortality

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.

Interventions

PROCEDURERALPPS

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.

PROCEDUREALPPS

Treat the hepatocellular carcinoma with ALPPS.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

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

Countries

China

Contacts

Primary ContactJun Yan, Ph.D

yanjun@sina.cn+86-23-18502327600

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026