RALPPS Venus ALPPS for Hepatocellular Carcinoma

Army Medical University

Status: Unknown

Conditions: Hepatocellular Carcinoma

Treatments: Procedure: ALPPS; Procedure: RALPPS

Study type: Interventional

Funder types: Other

Identifiers

NCT02299843

2014KYNO.51

Details and patient eligibility

About

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.

Enrollment: 32 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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32 participants in 2 patient groups

ALPPS

Active Comparator group

Description:

Using ALPPS for the the treatment of hepatocellular carcinoma.

Treatment:

Procedure: ALPPS

RALPPS

Experimental group

Description:

Using radiofrequency ablation instead of in-situ split of liver in ALPPS stage I（RALPPS）.Habib 4X was used in RFA.

Treatment:

Procedure: RALPPS