Preventive Effects of Parecoxib on Postoperative Complications in Hepatocellular Carcinoma Patients Undergoing Hepatic Transcatheter Arterial Chemoembolization

NCT ID: NCT02552745

Last Updated: 2016-01-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2015-04-30

Brief Summary

This study is aiming to understand the effects of parecoxib on the postoperative complications of hepatocellular carcinoma (HCC) patients undergoing hepatic transcatheter arterial embolization (TACE). The investigators enrolled 242 patients who were diagnosed with HCC for the first time and who received hepatic TACE at the Cancer Prevention and Treatment Center of Sun Yat-sen University from October 2014 to March 2015 were prospectively enrolled. The patients were divided into study and control groups according to whether parecoxib sodium was administered postoperatively. Pain scores,body temperature, vomiting, and changes in liver function after surgery, as well as the length of the hospital stay, were recorded and compared.

Conditions

Hepatocellular Carcinoma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

study group

parecoxib sodium was administered postoperatively

parecoxib sodium

Intervention Type: DRUG

parecoxib sodium was administered postoperatively, when transcatheter arterial embolization finished.

control group

parecoxib sodium was not administered postoperatively

No interventions assigned to this group

Interventions

parecoxib sodium

parecoxib sodium was administered postoperatively, when transcatheter arterial embolization finished.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Diagnosed with HCC according to the "primary liver cancer diagnosis and treatment practices" published by theMinistry of Health in 2011

2. A previous history of hepatitis B or positivity for hepatitis B surface antigen (HBsAg)

3. A Karnofsky Performance Status (KPS) score ≥70 points

4. Age between 18 and 65 years

5. Child-Pugh classA or B (class B patients had scores no greater than 7 points). In addition, the baseline laboratory tests had to meet the following criteria: white blood cells (WBCs) ≥1.5 × 109/L, platelets ≥50 × 109/L, hemoglobin ≥80 g/L, serum aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2 x the upper limit of normal (ULN), serum creatinine ≤ 1.5 x ULN, an international normalized ratio (INR)<1.5 or prothrombin time < the ULN + 4 seconds, albumin ≥30 g/L, and total bilirubin ≤34mmol/L

Exclusion Criteria

1. Patients who had iodine allergies, severe heart and lung diseases, significant fever or pain, or continuous use of anti-inflammatory drugs within the past three months were excluded

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Zhongguo Zhou

Department of Hepatobiliary Oncology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

B2012137

Identifier Type: -

Identifier Source: org_study_id