Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Selection Criteria for Safe Hepatectomy for Hepatocellular Carcinoma

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.
 
ClinicalTrials.gov Identifier: NCT02056041
Recruitment Status : Completed
First Posted : February 5, 2014
Last Update Posted : June 18, 2014
Sponsor:
Information provided by (Responsible Party):
Prof. Guido Torzilli, University of Milan

Brief Summary:
Selection criteria for safe hepatectomy for HCC are not well established. The aim of this study was the validation of the selection criteria for safe hepatectomy for hepatocellular carcinoma.

Condition or disease Intervention/treatment
Hepatectomy Hepatecellular Carcinoma Cirrhosis Procedure: Hepatectomy

Detailed Description:
All consecutive patients submitted to hepatectomy for HCC based on the same preoperative selection criteria from our prospectively-maintained liver unit database. Such criteria included the value of bilirubin (BIL), the value of cholinesterases (CHE), the presence of ascites, the presence of esophageal varices, and the rate of residual liver volume.

Layout table for study information
Study Type : Observational
Actual Enrollment : 336 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Selection Criteria for Safe Hepatectomy for Hepatocellular Carcinoma: Validation on 336 Consecutive Hepatectomies.
Study Start Date : January 2004
Actual Primary Completion Date : December 2013

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Hepatectomy for HCC
Patients submitted to surgery for HCC
Procedure: Hepatectomy
Other Names:
  • Liver surgery
  • Liver resection
  • Hepatic resection




Primary Outcome Measures :
  1. Safety of surgery for HCC [ Time Frame: 90 days ]
    The primary endpoint was the validation of our selection criteria for safe hepatectomy for HCC in regards to postoperative complications. The role of total bilirubin and cholinesterases was analzyed together with other clinical parameters.


Secondary Outcome Measures :
  1. Score systems HCC [ Time Frame: 90 days ]
    The secondary endpoint was the testing of the most common score systems for HCC, which are the CPT score, the MELD score, and the APRI score.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The records of 336 consecutive patients who were submitted to hepatectomy between 2004-2012 were reviewed.
Criteria

Inclusion Criteria:

  • any patient with HCC submitted to hepatic resection at our Unit in the established frame time

Exclusion Criteria:

  • any patient with missing data or lost at follow-up

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02056041


Locations
Layout table for location information
Italy
Humanitas Research Hospital
Rozzano, Milan, Italy, 20089
Sponsors and Collaborators
University of Milan
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Prof. Guido Torzilli, Professor of Surgery, University of Milan
ClinicalTrials.gov Identifier: NCT02056041    
Other Study ID Numbers: SafeSurgeryHCC
First Posted: February 5, 2014    Key Record Dates
Last Update Posted: June 18, 2014
Last Verified: June 2014
Additional relevant MeSH terms:
Layout table for MeSH terms
Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Liver Extracts
Hematinics