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

Completed

• Conditions: Hepatocellular Carcinoma
• Interventions: Drug: parecoxib sodium

• Registration Number: NCT02552745
• Lead Sponsor: Sun Yat-sen University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10
• Primary Completion: 2015-03
• Study Completion: 2015-04
• Study First Submitted: 2015-09-11
• Study First Submitted QC: 2015-09-15
• Study First Posted: 2015-09-17
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-02
• Last Update Posted: 2016-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
study group	parecoxib sodium	parecoxib sodium was administered postoperatively

Primary Outcome Measures

Name	Time	Method
Pain scores	3 days after TACE	VAS pain scores recorded after TACE

Secondary Outcome Measures

Name	Time	Method
Body temperature	3 Days after TACE	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.
Liver function	2 days after TACE	Before and after TACE to compare
Hospital Stay	within 3 days after discharge