RALPPS Venus ALPPS for Hepatocellular Carcinoma

Hepatocellular Carcinoma Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02299843
• Other study ID #: 2014KYNO.51
• Status: Recruiting
• Phase: N/A
• First received: November 17, 2014
• Last updated: November 30, 2015
• Start date: October 2014
• Est. completion date: December 2016

Study information

• Verified date: November 2015
• Source: Southwest Hospital, China
• Contact: Jun Yan, Ph.D
• Phone: +86-23-18502327600
• Email: yanjun[@]sina.cn
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: December 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

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.
• ALPPS
Treat the hepatocellular carcinoma with ALPPS.

Locations

Country	Name	City	State
China	Institute of hepatobiliary surgery,Southwest Hospital	Chongqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Southwest Hospital, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	morbidity during perioperation	complications include bile leakage, abdominal infection, hemorrhage, PHLF e.t.	2 years	No
Primary	mortality during perioperation		2 years	No