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Trial registered on ANZCTR


Registration number
ACTRN12610000063011
Ethics application status
Approved
Date submitted
11/01/2010
Date registered
19/01/2010
Date last updated
19/01/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Comparison of Liver Function After Hepatectomy in Cirrhotic Patients Between Isoflurane Inhaled and Propofol Intravenous in Anesthesia with Epidural Block
Scientific title
A prospective randomized controlled trial to compare postoperative liver functions, cytokines and complications between isoflurane inhaled and propofol intravenous anesthesia in cirrhotic patients undergoing hepatectomy for hepatic carcinoma
Secondary ID [1] 1284 0
nil
Universal Trial Number (UTN)
nil
Trial acronym
nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatic carcinoma resection among cirrhotic patients 256536 0
Condition category
Condition code
Anaesthesiology 256690 256690 0 0
Anaesthetics
Oral and Gastrointestinal 256707 256707 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Cancer 256708 256708 0 0
Liver

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
a) 1-1.5 minimum alveolar concentration (MAC) of isoflurane 1.15-1.75 % , the individual patient's dose is based on the clinical variables;
b) anaesthic administered from 30 minutes before commencement of surgery until completion of surgery (100-200 minutes in total)
c) the mode of administration: inhalation via tracheal tubing.
Intervention code [1] 255796 0
Treatment: Drugs
Comparator / control treatment
a) Target controled infusing(TCI) of propofol concentration of 3-6 ug.ml-1, the individual patient's dose is also based on the clinical variables
b) anaesthic administered from 30 minutes before commencement of surgery until completion of surgery (100-200 minutes in total)
c) the mode of administration:intravenous infusion
Control group
Active

Outcomes
Primary outcome [1] 257594 0
Postoperative liver fuctions and hepatocyte injury defined by peak alanine-aminotransferase (ALT) and aspartate-aminotransferase (AST) levels in blood analysis
Timepoint [1] 257594 0
On operation day,postoperative day 1,3,7
Secondary outcome [1] 262823 0
Serum Cytokine Tumor Necrosis Factor-a (TNFa) and Interleukin-1(IL1) levels
Timepoint [1] 262823 0
On operation day,postoperative day 1,3,7
Secondary outcome [2] 262825 0
Postoperative recovery: Hospital stay and Complications (eg. incidence rate (%) of hemorrhage,bile leak,wound infection,pleural effusion,hepatic decompensation,infective complications in each group, and postoperative complications were
assessed by treatment-oriented complication score.)
Timepoint [2] 262825 0
Entire Hospitalization

Eligibility
Key inclusion criteria
1. Elective liver resection
2. American Society of Anesthesiologists (ASA) physical status II-III patients
3. Primary liver cancer patients who had history of hepatitis B related cirrhosis
4. undergoing combined general and epidural anesthesia
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1.Contradictions 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 large or small ( 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.Indivduals fail to be performed Pringer’s maneuver due to technologic problem.

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)
60 ASA physical status II–III 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 informed consent.
Sequentially-Numbered, 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
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/12/2008
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] 2397 0
China
State/province [1] 2397 0
Shanghai

Funding & Sponsors
Funding source category [1] 256272 0
Other
Name [1] 256272 0
Shanghai Rising-Star Program (No 08QA14007)
Country [1] 256272 0
China
Primary sponsor type
Other
Name
Shanghai Rising-Star Program (No 08QA14007)
Address
Shanghai Committee of Science and Technology
200 People Avenue
Shanghai,200003, China
Country
China
Secondary sponsor category [1] 251610 0
None
Name [1] 251610 0
Address [1] 251610 0
Country [1] 251610 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258378 0
Institutional Review Board of the 3rd affiliated hospital
Ethics committee address [1] 258378 0
225 # Changhai Road
the 3rd affiliated hospital,
the Second Military Medical University,
Shanghai,200438,China
Ethics committee country [1] 258378 0
China
Date submitted for ethics approval [1] 258378 0
01/08/2008
Approval date [1] 258378 0
20/10/2008
Ethics approval number [1] 258378 0
ZD2008008-Y1

Summary
Brief summary
Liver resection may require hepatic inflow occlusion (Pringle’s maneuver) to diminish intraoperative blood loss, thus may result in transient ischemia followed by reperfusion, which may initiate liver injury and lead to postoperative liver dysfunction. Many protective strategies against ischemia reperfusion (IR) injury in the liver have been proposed, including surgical interventions, use of pharmacologic agents, or gene therapy, however, none of these methods has found its way into routine clinical practice. Therefore, therapeutic strategies to prevent liver tissue damage after IR have become the focus of extensive research efforts.
Recently, accumulating evidence suggests volatile anesthetics can attenuate liver IR injury through a mechanism of inducing some endogenous protective molecules such as heme-oxygenase (HO) enzyme system or hypoxia induced factor (HIF) etc, which suggest volatile anesthetics concerning pharmacological pretreatment would most likely be a hopeful way to prolonger the patient’s endurance to hepatic IR. Unfortunately, most of isoflurane hepatoprotection evidences and related mechanisms were based on the result of animal studies, as isoflurane are most clinically used anesthetic during liver resection worldwide.
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 IR injury. In order to test our hypothesis that using volatile anesthetics isoflurane can attenuate live IR injury rather than intravenous propofol in hepatectomy patients. We designed this clinical randomized comparative study to observer hepatectomy patients’ postoperative outcome especially liver function recovery when they received isofluare inhaled anesthesia or propofol injection respectively. We also compared serum proinflammatory factor and liver histiopathologic changes between 2 groups.
Trial website
nil
Trial related presentations / publications
nil
Public notes

Contacts
Principal investigator
Name 30681 0
Address 30681 0
Country 30681 0
Phone 30681 0
Fax 30681 0
Email 30681 0
Contact person for public queries
Name 13928 0
Dr. Liqun Yang M.D.
Address 13928 0
Department of Anaesthesia & Intensive Care
the 3rd Affiliated Hospital
the 2nd Military Medical University
225# Shanghai Road,
Shanghai,200438,China
Country 13928 0
China
Phone 13928 0
+8621-81875235
Fax 13928 0
+8621-81875231
Email 13928 0
[email protected]
Contact person for scientific queries
Name 4856 0
Prof. Wei-feng Yu M.D. Ph.D.
Address 4856 0
Department of Anaesthesia & Intensive Care
the 3rd Affiliated Hospital
the 2nd Military Medical University
225# Shanghai Road,
Shanghai,200438,China
Country 4856 0
China
Phone 4856 0
+8621-81875231
Fax 4856 0
+8621-81875231
Email 4856 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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