Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000245099
Ethics application status
Not yet submitted
Date submitted
15/03/2010
Date registered
24/03/2010
Date last updated
24/03/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of Parecoxib on postoperative liver function in Patients Undergoing hepatectomy of hepatic carcinoma
Scientific title
Effects of Parecoxib, a selective cyclooxygenase-2 inhibitor,on liver function in Patients Undergoing hepatectomy of hepatic carcinoma: A Double-Blind, Randomized, Comparative Study
Secondary ID [1] 1523 0
None
Universal Trial Number (UTN)
None
Trial acronym
None
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatic carcinoma resection among crirhotic patients 256969 0
Condition category
Condition code
Anaesthesiology 257112 257112 0 0
Anaesthetics
Cancer 257113 257113 0 0
Liver

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1)Target controlled infusing(TCI) of propofol concentration of 3-6 ug/min, the individual patient’s dose is base on the clinical variables. 2)anaesthic administered from 30 minutes before commencement of surgery until completion of surgery. 3) the mode of administration: intravenous infusion .4) parecoxib 50mg intravenous infusion before cut skin and again after 6 hours . 5) Patient-controlled intravenous analgesia(PCIA) sufentanil will be administered for 2 days(background infusion is 2ml/h(sufentanil 2.4ug/h),bolus does is 2ml(sufentanil 2.4ug))
Intervention code [1] 256146 0
Treatment: Drugs
Comparator / control treatment
1) the mode of administration: intravenous infusion .2) saline solution (as placebo)10ml intravenous infusion before cut skin and again after 6 hours. 3) Patient-controlled intravenous analgesia(PCIA) sufentanil will be administered for 2 days(background infusion is 2ml/h(sufentanil 2.4ug/h),bolus does is 2ml(sufentanil 2.4ug))
Control group
Placebo

Outcomes
Primary outcome [1] 258007 0
postoperative liver fuctions and hepatocyte injury defined by peak alanine-aminoteansferase(ALT) and aspartate-aminoreaansferrase(AST) levels in serum analysis.
Timepoint [1] 258007 0
on operation day, postoperative day 1,3,7
Primary outcome [2] 258073 0
postoperative pain levels are measured by numerical rating scale(RNS) pain scores,dose and frequency of rescues analgesic (hypodermic injection of morphine) use
Timepoint [2] 258073 0
on operation day, postoperative day 1,3,7
Secondary outcome [1] 263565 0
inflammatory stress is measured by serum cytokine tumor necrosis factor-a(TNF-a) and serum Interleukin-1(IL-1)
Timepoint [1] 263565 0
on operation day,postoperative day 1,3,7

Eligibility
Key inclusion criteria
1.elective liver resection 2. American Society of Anesthesiologists (ASA) physical status 2-3 patients 3.Primary liver cancer patients who had history of hepatitis B related cirrhosis 4.undergoing combine general and epidural anesthesia
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1contradictions of epidural puncture including coagulate disorder (prothrombin time (PT) longer than 15 sec or/and blood platelets count less than 10,000 ).
2.tumor size too small or too large(longitude of tumor was beyond 3-8 cm ) or estimated blood loss was large than 1000 cc.
3.Individuals in whom the regional block failed and surgery was performed under general anesthesia alone were also withdrawn from the study..
4.Patients with a known allergy to NSAIDs
5.Patients who had received chemotherapy and radiation prior to surgery
6.patients who with a history of peptic ulceration, or renal, cardiac, endocrine
7. Patients who had received Non steroidal anti-inflammatory drugs (NSAIDs) within 14 days before enrollment

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
ASA II-III physical status patients who underwent hepatectomy surgery for resection the hepatic neoplasms who had history of hepatitis B related cirrhosis under combined general and epidural anesthesia were enrolled after signed an approved information consent. Sequentially-Numered,Opaque,Sealed Envelopes(SNOSE) were used as allocation concealment method.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization was based on computer-generated codes that were maintained in opaque envelopes until the anesthesia began
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/04/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 2541 0
China
State/province [1] 2541 0
shanghai

Funding & Sponsors
Funding source category [1] 256649 0
Hospital
Name [1] 256649 0
Department of Anaesthesia & Intensive Care the 3rd Affillated Hospital the 2nd Military Medical University
Country [1] 256649 0
China
Primary sponsor type
Individual
Name
jinmin zhang
Address
No.255 Changhai Road,shanghai,
200438,China
Country
China
Secondary sponsor category [1] 255936 0
Individual
Name [1] 255936 0
liqun yang
Address [1] 255936 0
No.255 Changhai Road,shanghai,
200438,China
Country [1] 255936 0
China

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 258673 0
Ethics Committee of the 3rd Affillated Hospital the 2nd Military Medical University
Ethics committee address [1] 258673 0
No.255 Changhai Road,shanghai,
200438,China
Ethics committee country [1] 258673 0
China
Date submitted for ethics approval [1] 258673 0
15/03/2010
Approval date [1] 258673 0
Ethics approval number [1] 258673 0

Summary
Brief summary
Liver resection may require hepatic inflow occlusion to diminish intraoperative blood loss,thus may result in transient ischemia followed by reperfusion(I/R),which may initiate liver injury and lead to postoperative liver dysfunction. Nonsteroidal anti-inflammatory drugs (NSAIDs) may prevent or reduce hyperalgesia, inhibit inflammation, and reduce pain by reducing the synthesis of prostaglandins in response to tissue damage caused by surgery. There are some hepatic side effects reported by several spontaneous reports. While evidence from animal studies has shown that administration of COX-2 inhibitors minimize hepatic necrosis in chloroform induced liver injury. The aim of this study is to compare the effects of parecoxib, flurbiprofen and placebo in patients undergoing hepatectomy of hepatic carcinoma. Since Pringle’s maneuver are commonly applied by most of surgeons in our center which also cause an inevitable liver damage perioperatively, therefore providing us an ideal clinic model of hepatic I/R injury. The pain under mobilization registered via a visual analogue score. The injury of hepatocytes is evaluated by measuring plasma levels of alanine transaminase (ALT),aspartate aminotransferase(AST),interleukin 1 (IL-1), and tumor necrosis factor alpha (TNFa) levels. postoperative recovery is evaluated by hospital stay and complications. Liver resection may require hepatic inflow occlusion to diminish intraoperative blood loss,thus may result in transient ischemia followed by reperfusion(I/R),which may initiate liver injury and lead to postoperative liver dysfunction.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30936 0
Address 30936 0
Country 30936 0
Phone 30936 0
Fax 30936 0
Email 30936 0
Contact person for public queries
Name 14183 0
jinmin zhang
Address 14183 0
Department of Anaesthesia & Intensive Care the 3rd Affillated Hospital the 2nd Military Medical University,No.255 Changhai Road,shanghai, 200438,China
Country 14183 0
China
Phone 14183 0
+8621-81875231
Fax 14183 0
+8621-81875231
Email 14183 0
jim530102@yahoo.com.cn
Contact person for scientific queries
Name 5111 0
jinmin zhang
Address 5111 0
Department of Anaesthesia & Intensive Care the 3rd Affillated Hospital the 2nd Military Medical University,No.255 Changhai Road,shanghai, 200438,China
Country 5111 0
China
Phone 5111 0
+8621-81875231
Fax 5111 0
+8621-81875231
Email 5111 0
jim530102@yahoo.com.cn

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Results publications and other study-related documents

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