- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02965131
The Effects of the Anhepatic Phase Extended by Temporary Portocaval Shunt on Anesthetic Sensitivity and Cognitive Function
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 Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Non-temporary portocaval shunt
No temporary portacaval shunt is created.
Full mobilization of the liver was followed by dissection of the hilar structure.
|
|
Experimental: Temporary portocaval shunt
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
Seven day after living donor liver transplantation
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Bispectral index values
Time Frame: During the preanhepatic, anhepatic, and neohepatic
|
During the preanhepatic, anhepatic, and neohepatic
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CR-16-159
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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