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RALPPS Venus ALPPS for Hepatocellular Carcinoma

NCT ID: NCT02299843

Last Updated: 2015-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2016-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Hepatocellular Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ALPPS

Using ALPPS for the the treatment of hepatocellular carcinoma.

Group Type ACTIVE_COMPARATOR

ALPPS

Intervention Type PROCEDURE

Treat the hepatocellular carcinoma with ALPPS.

RALPPS

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

Group Type EXPERIMENTAL

RALPPS

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

ALPPS

Treat the hepatocellular carcinoma with ALPPS.

Intervention Type PROCEDURE

Eligibility Criteria

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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.

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Southwest Hospital, China

OTHER

Sponsor Role lead

Responsible Party

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Yan Jun

institute of hepatobiliary surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kuansheng Ma, Ph.D

Role: STUDY_DIRECTOR

Institute of hepatobiliary surgery,Southwest Hospital

Locations

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Institute of hepatobiliary surgery,Southwest Hospital

Chongqing, Chongqing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jun Yan, Ph.D

Role: CONTACT

[email protected]
+86-23-18502327600

Facility Contacts

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Jun Yan, Ph.D

Role: primary

[email protected]
+86-23-18502327600

Other Identifiers

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2014KYNO.51

Identifier Type: -

Identifier Source: org_study_id