NCT02056041

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
336

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
9.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 3, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 5, 2014

Completed
Last Updated

June 18, 2014

Status Verified

June 1, 2014

Enrollment Period

9.9 years

First QC Date

February 3, 2014

Last Update Submit

June 17, 2014

Conditions

HepatectomyHepatecellular CarcinomaCirrhosis

Outcome Measures

Primary Outcomes (1)

  • Safety of surgery for HCC

    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.

    90 days

Secondary Outcomes (1)

  • Score systems HCC

    90 days

Study Arms (1)

Hepatectomy for HCC

Patients submitted to surgery for HCC

Procedure: Hepatectomy

Interventions

HepatectomyPROCEDURE
Also known as: Liver surgery, Liver resection, Hepatic resection
Hepatectomy for HCC

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The records of 336 consecutive patients who were submitted to hepatectomy between 2004-2012 were reviewed.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Humanitas Research Hospital

Rozzano, Milan, 20089, Italy

Location

Related Publications (1)

  • 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.

    PMID: 25217112DERIVED

MeSH Terms

Conditions

Fibrosis

Interventions

Hepatectomy

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Digestive System Surgical ProceduresSurgical Procedures, Operative

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Surgery

Study Record Dates

First Submitted

February 3, 2014

First Posted

February 5, 2014

Study Start

January 1, 2004

Primary Completion

December 1, 2013

Last Updated

June 18, 2014

Record last verified: 2014-06

Locations

IT(1)