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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

Tracking Information
First Submitted Date February 3, 2014
First Posted Date February 5, 2014
Last Update Posted Date June 18, 2014
Study Start Date January 2004
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 4, 2014)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: February 4, 2014)
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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Selection Criteria for Safe Hepatectomy for Hepatocellular Carcinoma
Official Title Selection Criteria for Safe Hepatectomy for Hepatocellular Carcinoma: Validation on 336 Consecutive Hepatectomies.
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.
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population The records of 336 consecutive patients who were submitted to hepatectomy between 2004-2012 were reviewed.
Condition
  • Hepatectomy
  • Hepatecellular Carcinoma
  • Cirrhosis
Intervention Procedure: Hepatectomy
Other Names:
  • Liver surgery
  • Liver resection
  • Hepatic resection
Study Groups/Cohorts Hepatectomy for HCC
Patients submitted to surgery for HCC
Intervention: Procedure: Hepatectomy
Publications * Donadon M, Costa G, Cimino M, Procopio F, Fabbro DD, Palmisano A, Torzilli G. Safe hepatectomy selection criteria for hepatocellular carcinoma patients: a validation of 336 consecutive hepatectomies. The BILCHE score. World J Surg. 2015 Jan;39(1):237-43. doi: 10.1007/s00268-014-2786-6.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: February 4, 2014)
336
Original Actual Enrollment Same as current
Study Completion Date Not Provided
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Italy
Removed Location Countries  
 
Administrative Information
NCT Number NCT02056041
Other Study ID Numbers SafeSurgeryHCC
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Prof. Guido Torzilli, University of Milan
Study Sponsor University of Milan
Collaborators Not Provided
Investigators Not Provided
PRS Account University of Milan
Verification Date June 2014