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Estimation of Functional Liver Reserve Using Cholinesterases

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ClinicalTrials.gov Identifier: NCT00883454
Recruitment Status : Completed
First Posted : April 17, 2009
Last Update Posted : April 17, 2009
Sponsor:
Information provided by:
University of Milan

Study Description
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Brief Summary:
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.

Condition or disease
Hepatocellular Carcinoma Cirrhosis Liver Neoplasm Liver Disease

Study Design
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Study Type : Observational
Actual Enrollment : 181 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Estimation of Functional Liver Reserve in Patients With Hepatocellular Carcinoma in Cirrhosis: the Value of Preoperative Cholinesterases

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cirrhosis
U.S. FDA Resources

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. The primary outcome was to investigate the value of preoperative cholinesterases in predict postoperative adverse outcome after hepatic resection for hepatocellular carcinoma in cirrhosis.

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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).
Criteria

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
Contacts and Locations
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00883454


Locations
Italy
Liver Surgery Unit, Third Department of Surgery, University of MIlan, IRCCS Istituto Clinico Humanitas
Rozzano, Milan, Milan, Italy, 20089
Sponsors and Collaborators
University of Milan
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

ClinicalTrials.gov Identifier: NCT00883454     History of Changes
Other Study ID Numbers: CHE-HCC
First Posted: April 17, 2009    Key Record Dates
Last Update Posted: April 17, 2009
Last Verified: April 2009

Keywords provided by University of Milan:
hepatocellular carcinoma
liver tumor
cirrhosis
 liver resection
tumor staging
liver disease staging

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Fibrosis
Liver Cirrhosis
Liver Diseases
Liver Neoplasms
Neoplasms, Glandular and Epithelial
 Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Pathologic Processes