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Estimation of Functional Liver Reserve Using Cholinesterases

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00883454
First Posted: April 17, 2009
Last Update Posted: April 17, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Milan
April 16, 2009
April 17, 2009
April 17, 2009
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The primary outcome was to investigate the value of preoperative cholinesterases in predict postoperative adverse outcome after hepatic resection for hepatocellular carcinoma in cirrhosis.
Same as current
No Changes Posted
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Estimation of Functional Liver Reserve Using Cholinesterases
Estimation of Functional Liver Reserve in Patients With Hepatocellular Carcinoma in Cirrhosis: the Value of Preoperative Cholinesterases
Estimation of functional liver reserve in patients with hepatocellular carcinoma (HCC) in cirrhosis is of paramount importance to properly select candidates for surgical resection. Together with the value of bilirubin, the presence/absence of ascites and esophageal varices, and the rate of residual liver volume, which are our current parameters to measure functional liver reserve, the investigators sought to investigate the value of preoperative cholinesterases (CHE) in predict postoperative adverse outcome after hepatic resection for HCC.
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Observational
Observational Model: Cohort
Time Perspective: Retrospective
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Non-Probability Sample
The records of approximately 245 consecutive patients who were referred at our Unit because of HCC were reviewed. Among those, 191 (78%) were submitted to surgery, and 181 (74%) were resected. The patients excluded from surgery were addressed to symptomatic treatments because of advanced disease or impaired liver functional reserve, or to percutaneous ablation therapy according to our policy. Among resected patients, there were 145 (80%) men and 36 (20%) women, with median age of 67 years (range 36-87 years).
  • Hepatocellular Carcinoma
  • Cirrhosis
  • Liver Neoplasm
  • Liver Disease
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
181
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Inclusion Criteria:

  1. Total bilirubin < 2 mg/dl
  2. No ascites
  3. No esophageal varices, or esophageal varices eradicated by endoscopy
  4. Liver volume:

    • residual liver volume > or = 40% if total bilirubin < 1 mg/dl
    • residual liver volume > or = 50% if total bilirubin between 1 and 1.5 mg/dl
    • only limited resection if total bilirubin > 1.5 mg/dl
  5. Portal vein embolization was selected in any case in whom RLV did not fit the previous requirements.

Exclusion Criteria:

  1. Total bilirubin > 2 mg/dl
  2. Refractory ascites
  3. Esophageal varices
Sexes Eligible for Study: All
18 Years to 90 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
 
NCT00883454
CHE-HCC
No
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University of Milan
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University of Milan
April 2009