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

NCT02552745 | Completed

• 1 other identifier: B2012137
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Pain scores

  VAS pain scores recorded after TACE

  3 days after TACE

Secondary Outcomes (3)

• Body temperature

  3 Days after TACE

• Liver function

  2 days after TACE

• Hospital Stay

  within 3 days after discharge

Study Arms (2)

study group

parecoxib sodium was administered postoperatively

Drug: parecoxib sodium

control group

parecoxib sodium was not administered postoperatively

Interventions

parecoxib sodium DRUG

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

study group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

diagnosed with HCC according to the "primary liver cancer diagnosis and treatment practices" published by the Ministry of Health in 2011 China.

You may qualify if:

• 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

You may not qualify if:

• \. 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

Sponsors & Collaborators

• Sun Yat-sen University: lead

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

parecoxib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Hepatobiliary Oncology

Study Record Dates

• First Submitted: September 11, 2015
• First Posted: September 17, 2015
• Study Start: October 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: April 1, 2015
• Last Updated: January 5, 2016

Record last verified: 2016-01