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The Effects of the Anhepatic Phase Extended by Temporary Portocaval Shunt on Anesthetic Sensitivity and Cognitive Function

Primary Purpose

Liver Cirrhoses

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Temporary portocaval shunt
Sponsored by
Daegu Catholic University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Liver Cirrhoses

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Liver cirrhosis regardless of the concurrent presence of hepatocellular carcinoma

Exclusion Criteria:

  • Alcoholic liver cirrhosis
  • Acute liver failure
  • A history of central nervous system disease (e.g., hepatic encephalopathy)
  • Use of psychoactive drugs or alcohol within 6 months before the study
  • Flapping tremor affecting handwriting performance necessary for assessing constructional praxis
  • Difficulty in communicating with medical personnel
  • Bispectral index values more than 60 under the predetermined end-tidal minimum alveolar concentration of desflurane during general anesthesia
  • Reoperations
  • Failure to wean from mechanical ventilation within 24 hours of arrival in the surgical intensive care unit
  • Patient refusal

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    Non-temporary portocaval shunt

    Temporary portocaval shunt

    Arm Description

    No temporary portacaval shunt is created. Full mobilization of the liver was followed by dissection of the hilar structure.

    Temporary portocaval shunt is created when inadvertent massive perihepatic bleeding or technical difficulties due to untypical patients' perihepatic anatomy are encountered during total hepatectomy. Hilar dissection preceded the dissection of the retrohepatic vena cava from the native liver. Its creating prolongs the duration of the anhepatic phase.

    Outcomes

    Primary Outcome Measures

    Mini-Mental State Examination in the Korean Version of the Consortium to Establish a Registry for Alzheimer's Assessment Packet score

    Secondary Outcome Measures

    Bispectral index values

    Full Information

    First Posted
    November 11, 2016
    Last Updated
    November 15, 2016
    Sponsor
    Daegu Catholic University Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02965131
    Brief Title
    The Effects of the Anhepatic Phase Extended by Temporary Portocaval Shunt on Anesthetic Sensitivity and Cognitive Function
    Official Title
    The Effects of the Anhepatic Phase Extended by Temporary Portocaval Shunt on Anesthetic Sensitivity to Desflurane Administered at Constant Minimum Alveolar Concentration and Its Associative Postoperative Cognitive Function
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2014 (undefined)
    Primary Completion Date
    January 2016 (Actual)
    Study Completion Date
    January 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Daegu Catholic University Medical Center

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This study aims to investigate the effects of the anhepatic phase extended by temporary portocaval shunt on the sensitivity to desflurane administered at 0.6 age-adjusted minimum alveolar concentration and its associative postoperative cognitive function.
    Detailed Description
    The primary end point of this study is the mini-mental state examination in the Korean version of the consortium to establish a registry for Alzheimer's disease assessment packet (MMSE-KC) score obtained 7 days after living donor liver transplantation (LDLT). A sample size of 78 patients was calculated to detect a difference of 2.5 in the MMSE-KC score 7 days after LDLT between the temporary portocaval shunt (TPCS) and non-TPCS groups, achieving a statistical power of 80% at a two-tailed alpha error of 5% under a standard deviation of 3, an unequal allocation ratio between the groups (non-TPCS:TPCS = 83:33), which is the ratio of both types of surgery performed between May 2011 and October 2013 in our institution, and a drop-out rate of 20%, on the assumption that the Mann-Whitney U test would be performed due to the non-normal distribution of MMSE-KC scores in the TPCS group. A small number of patients was expected to be assigned to the TPCS group based on the number of previous cases in our institution and the stringent exclusion criteria. The data are presented as the means ± standard deviations for normally distributed data, medians (1st quartile - 3rd quartile) for non-normally distributed data, and numbers of patients (percentage) for qualitative data. The assumption of normality is tested using the Kolmogorov-Smirnov and Shapiro-Wilk tests. If at least one null hypothesis of the two tests is not rejected, the data are determined to be normally distributed. Univariate comparisons between the two groups are performed using independent samples Student's t-test for normally distributed variables, the Mann-Whitney U test for non-normally distributed variables, and Fisher's exact test for categorical variables. If Student's t-test is used, the 95% confidence interval of the mean difference and the corresponding P-value is presented. Repeated measures analysis of variance with post hoc paired Student's t-test using Bonferroni correction is performed for normally distributed variables to determine the significance of between- and within-groups effects and interaction between the variables (group versus phase). To determine the significant interval change in non-normally distributed variables during surgery, Friedman's test with post hoc Wilcoxon signed-rank test under Bonferroni correction is used. For the comparison of within-group changes in the total sum scores and subscores of the MMSE-KC, Wilcoxon signed rank test is used. Rank analysis of covariance is used to compare the MMSE-KC score obtained 7 days after surgery between the groups by controlling for the covariates that are found to correlate with the score based on nonparametric Spearman's correlation analysis. The statistical analysis is performed using IBM SPSS Statistics software, version 19.0.0 (IBM Corp., Armonk, NY, United States). A two-tailed P < 0.05 is considered statistically significant.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Liver Cirrhoses

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Non-Randomized
    Enrollment
    67 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Non-temporary portocaval shunt
    Arm Type
    No Intervention
    Arm Description
    No temporary portacaval shunt is created. Full mobilization of the liver was followed by dissection of the hilar structure.
    Arm Title
    Temporary portocaval shunt
    Arm Type
    Experimental
    Arm Description
    Temporary portocaval shunt is created when inadvertent massive perihepatic bleeding or technical difficulties due to untypical patients' perihepatic anatomy are encountered during total hepatectomy. Hilar dissection preceded the dissection of the retrohepatic vena cava from the native liver. Its creating prolongs the duration of the anhepatic phase.
    Intervention Type
    Procedure
    Intervention Name(s)
    Temporary portocaval shunt
    Intervention Description
    The hepatic artery, bile duct, and portal vein are dissected and clamped. The retrohepatic vena cava is preserved with selective clamping of the hepatic veins during total hepatectomy. Then, temporary portocaval shunt is constructed by end-to-end anastomosis of the portal vein stump to the middle and left hepatic vein trunk or by end-to-side anastomosis of the stump to the infrahepatic vena cava depending on the remaining length of the vessels.
    Primary Outcome Measure Information:
    Title
    Mini-Mental State Examination in the Korean Version of the Consortium to Establish a Registry for Alzheimer's Assessment Packet score
    Time Frame
    Seven day after living donor liver transplantation
    Secondary Outcome Measure Information:
    Title
    Bispectral index values
    Time Frame
    During the preanhepatic, anhepatic, and neohepatic

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Liver cirrhosis regardless of the concurrent presence of hepatocellular carcinoma Exclusion Criteria: Alcoholic liver cirrhosis Acute liver failure A history of central nervous system disease (e.g., hepatic encephalopathy) Use of psychoactive drugs or alcohol within 6 months before the study Flapping tremor affecting handwriting performance necessary for assessing constructional praxis Difficulty in communicating with medical personnel Bispectral index values more than 60 under the predetermined end-tidal minimum alveolar concentration of desflurane during general anesthesia Reoperations Failure to wean from mechanical ventilation within 24 hours of arrival in the surgical intensive care unit Patient refusal

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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