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.
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 32
- Locations
- 1
- Primary Endpoint
- morbidity during perioperation
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
ALPPS
Using ALPPS for the the treatment of hepatocellular carcinoma.
Intervention: ALPPS (Procedure)
RALPPS
Using radiofrequency ablation instead of in-situ split of liver in ALPPS stage I（RALPPS）.Habib 4X was used in RFA.
Intervention: RALPPS (Procedure)
Outcomes
Primary Outcomes
morbidity during perioperation
Time Frame: 2 years
complications include bile leakage, abdominal infection, hemorrhage, PHLF e.t.
mortality during perioperation
Time Frame: 2 years
Secondary Outcomes
No secondary outcomes reported
Investigators
Yan Jun
institute of hepatobiliary surgery
Southwest Hospital, China