Liver Transplantation Results in Hepatocellular Carcinoma Patients With Immunosuppression Without Steroids

Shanghai Jiao Tong University School of Medicine

Status: Completed

Conditions: Liver Transplantation; Hepatocellular Carcinoma; Post-operative Complications; Immunosuppression

Treatments: Drug: solu medrol; Drug: a steroid-free immunosuppression protocol

Study type: Interventional

Funder types: Other

Identifiers

NCT01137084

20100603

Details and patient eligibility

About

The purpose of this study was to evaluate the safety and efficacy of a steroid-free immunosuppression protocol in Hepatocellular Carcinoma (HCC) patients.

Enrollment: 300 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• All liver transplantation patients with hepatocellular carcinoma in our center between Jan 2005 and Dec 2009 were potentially eligible for enrollment

Exclusion criteria

• the recipient pass away within 3 month following up liver transplantation
• Inability to provide written informed consent prior to study entry
• acute rejection are treated only with steroids

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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300 participants in 2 patient groups

a steroid immunosuppression protocol

Active Comparator group

Treatment:

Drug: solu medrol

a steroid-free immunosuppression protocol

Active Comparator group

Description:

without steroid

Treatment:

Drug: a steroid-free immunosuppression protocol