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

Hepatocellular Carcinoma Clinical Trial

Official title:

Sun Yat-sen University Cancer Center

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02552745
• Other study ID #: B2012137
• Status: Completed
• Phase: N/A
• First received: September 11, 2015
• Last updated: January 2, 2016
• Start date: October 2014
• Est. completion date: April 2015

Study information

• Verified date: January 2016
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Health and Family Planning Commission of Guangdong Province
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: April 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma
• Postoperative Complications

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain scores	VAS pain scores recorded after TACE	3 days after TACE	No
Secondary	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	No
Secondary	Liver function	Before and after TACE to compare	2 days after TACE	No
Secondary	Hospital Stay		within 3 days after discharge	No