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

Study Overview
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Brief Summary
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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.

Official Title
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Sun Yat-sen University Cancer Center

Conditions
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Hepatocellular Carcinoma

Intervention / Treatment
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* Drug: parecoxib sodium


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed with HCC according to the primary liver cancer diagnosis and treatment practices published by theMinistry of Health in 2011 A previous history of hepatitis B or positivity for hepatitis B surface antigen (HBsAg) A Karnofsky Performance Status (KPS) score ≥70 points Age between 18 and 65 years 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| study group<br>parecoxib sodium was administered postoperatively | Drug: parecoxib sodium<br>* parecoxib sodium was administered postoperatively, when transcatheter arterial embolization finished.<br>|
| control group<br>parecoxib sodium was not administered postoperatively | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain scores | VAS pain scores recorded after TACE | 3 days after TACE | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body temperature | The maximum daily temperature at each of the time points were recorded before TACE,two hours postoperative, and the first, second, and third postoperative days, respectively. | 3 Days after TACE | 
| Liver function | Before and after TACE to compare | 2 days after TACE | 
| Hospital Stay |  | within 3 days after discharge |