HepatectomyNCT02056041
Selection Criteria for Safe Hepatectomy for Hepatocellular Carcinoma
An observational study of Hepatectomy and Hepatecellular Carcinoma, run by University of Milan at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Hepatectomy, Hepatecellular Carcinoma, Cirrhosis
- What is being tested?
- Hepatectomy
- Type of treatment
- Surgery or procedure
- How many people
- 336 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2004to Dec 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The records of 336 consecutive patients who were submitted to hepatectomy between 2004-2012 were reviewed.
Who may be able to join
- any patient with HCC submitted to hepatic resection at our Unit in the established frame time
Who cannot join
- any patient with missing data or lost at follow-up
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Selection Criteria for Safe Hepatectomy for Hepatocellular Carcinoma: Validation on 336 Consecutive Hepatectomies.
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.
Read the 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.
- Conditions
- Hepatectomy, Hepatecellular Carcinoma, Cirrhosis
- Being tested
- Hepatectomy
- Medical subject headings
- Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HepatectomyProcedure or surgery
Also called Liver surgery, Liver resection, Hepatic resection
| Study group | Role | What they receive |
|---|---|---|
| Hepatectomy for HCC | Patients submitted to surgery for HCC Receives: Procedure: Hepatectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 90 days
Secondary outcomes (1)
Score systems HCC
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.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2014 (estimated)
- Study startJan 2004
- Primary completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HepatectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 336 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Milan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Guido Torzilli, University of Milan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02056041
- Sponsor's protocol ID
- SafeSurgeryHCC
- Status last verified
- Jun 2014
- First submitted
- 3 Feb 2014
- Last updated
- 18 Jun 2014
- Results posted
- No
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.
PubMed 25217112
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Selection Criteria for Safe Hepatectomy for Hepatocellular Carcinoma: Validation on 336 Consecutive Hepatectomies.
- ClinicalTrials.gov ID
- NCT02056041
- Acronym / sponsor ID
- SafeSurgeryHCC
- Conditions
- Hepatectomy, Hepatecellular Carcinoma, Cirrhosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 336 participants (actual)
- Lead sponsor
- University of MilanUniversity, hospital or other
- Study start
- Jan 2004
- Primary completion
- Dec 2013 (actual)
- First posted
- 5 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hepatectomy for HCC | – | Procedure: HepatectomyPatients submitted to surgery for HCC |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The records of 336 consecutive patients who were submitted to hepatectomy between 2004-2012 were reviewed.
Key inclusion criteria (1 listed)
- any patient with HCC submitted to hepatic resection at our Unit in the established frame time
Key exclusion criteria (1 listed)
- any patient with missing data or lost at follow-up
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HepatectomyAlso: Liver surgery, Liver resection, Hepatic resection | Procedure or surgery | Hepatectomy for HCC |
Primary outcome
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.
1 secondary outcome
Score systems HCC
Time frame: 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2014.
- Derived from this study: PubMed 25217112Donadon 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatectomy and Hepatecellular Carcinoma, run by University of Milan at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of surgery for HCC (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02056041, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2014.