SurgeryNCT03171428
Hepatectomy With or Without the Thoraco-abdominal Approach
An observational study of Surgery and Liver Tumors, run by University of Milan.
Trial summary
The performance of hepatectomy for liver tumors using the thoraco-abdominal approach (TAA) versus the abdominal approach (AA) is still debated. The aim of the study is the analysis of the perioperative outcome of patients operated with or without the TAA for liver tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgery, Liver Tumors, Hepatectomy
- What is being tested?
- Hepatectomy
- Type of treatment
- Surgery or procedure
- How many people
- 744 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2007to 1 Apr 2015
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients affected by liver tumors scheduled for hepatectomy at our center.
Who may be able to join
- First liver surgery;
- Any type of malignant liver tumor, including hepatocellular carcinoma on cirrhosis.
Who cannot join
- Previous history of liver surgery;
- Any type of benign liver tumor;
- Incomplete clinical, surgical, pathological or postoperative data;
- Patients treated with radiofrequency ablation alone or in combination with surgery were also excluded.
About this study
Official title: Hepatectomy With or Without the Thoraco-abdominal Approach: Impact on Perioperative Outcome
The performance of hepatectomy for liver tumors using the thoraco-abdominal approach (TAA) versus the abdominal approach (AA) is still debated.
The aim of the study is the analysis of the perioperative outcome of patients operated with or without the TAA for liver tumors.
Read the detailed description
The prospectively maintained database was queried. A 1:1 propensity score-matched analysis was applied. Among 744 patients, 246 undergoing hepatectomy with TAA and 246 undergoing hepatectomy with AA were compared. These patients were matched for baseline characteristics, underlying liver disease, comorbidity, tumor features, and extent of the resection. The rates of morbidity and mortality were the study endpoints.
- Conditions
- Surgery, Liver Tumors, Hepatectomy, Liver Resection
- Being tested
- Hepatectomy
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HepatectomyProcedure or surgery
Also called hepatic resection; liver resection; liver surgery
Surgery for liver tumors is the removal of a part of the liver affected by a tumor.
| Study group | Role | What they receive |
|---|---|---|
| TAA | Thoraco-Abdominal Approach: those patients with liver tumors operated with the thoracic-abdominal approach Receives: Procedure: Hepatectomy | |
| AA | Abdominal Approach: those patients with liver tumors operated with the abdominal approach (without the thoracotomy) Receives: Procedure: Hepatectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short-term outcome: Occurrence of postoperative complications or death after surgery
Occurrence of postoperative complications or death after surgery
Measured: Within 90-days after the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2017
- Study start1 Jan 2007
- Primary completion31 Dec 2013
- Study completion1 Apr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 744 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
- NCT03171428
- Sponsor's protocol ID
- ThoraxForLiver
- Status last verified
- May 2017
- First submitted
- 28 May 2017
- Last updated
- 1 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hepatectomy With or Without the Thoraco-abdominal Approach: Impact on Perioperative Outcome
- ClinicalTrials.gov ID
- NCT03171428
- Acronym / sponsor ID
- ThoraxForLiver
- Conditions
- Surgery, Liver Tumors, Hepatectomy, Liver Resection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 744 participants (actual)
- Lead sponsor
- University of MilanUniversity, hospital or other
- Study start
- 1 Jan 2007 (actual)
- Primary completion
- 31 Dec 2013 (actual)
- Study completion
- 1 Apr 2015 (actual)
- First posted
- 31 May 2017 (actual)
- 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.
The performance of hepatectomy for liver tumors using the thoraco-abdominal approach (TAA) versus the abdominal approach (AA) is still debated.
The aim of the study is the analysis of the perioperative outcome of patients operated with or without the TAA for liver tumors.
Detailed description
The prospectively maintained database was queried. A 1:1 propensity score-matched analysis was applied. Among 744 patients, 246 undergoing hepatectomy with TAA and 246 undergoing hepatectomy with AA were compared. These patients were matched for baseline characteristics, underlying liver disease, comorbidity, tumor features, and extent of the resection. The rates of morbidity and mortality were the study endpoints.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TAA | – | Procedure: HepatectomyThoraco-Abdominal Approach: those patients with liver tumors operated with the thoracic-abdominal approach |
| AA | – | Procedure: HepatectomyAbdominal Approach: those patients with liver tumors operated with the abdominal approach (without the thoracotomy) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients affected by liver tumors scheduled for hepatectomy at our center.
Key inclusion criteria (2 listed)
- First liver surgery;
- Any type of malignant liver tumor, including hepatocellular carcinoma on cirrhosis.
Key exclusion criteria (4 listed)
- Previous history of liver surgery;
- Any type of benign liver tumor;
- Incomplete clinical, surgical, pathological or postoperative data;
- Patients treated with radiofrequency ablation alone or in combination with surgery were also excluded.
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: hepatic resection; liver resection; liver surgerySurgery for liver tumors is the removal of a part of the liver affected by a tumor. | Procedure or surgery | AA, TAA |
Primary outcome
Short-term outcome: Occurrence of postoperative complications or death after surgery
Time frame: Within 90-days after the operation
Occurrence of postoperative complications or death after surgery
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 1 Jun 2017.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgery and Liver Tumors, run by University of Milan.
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 2 inclusion and 4 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 1 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Short-term outcome: Occurrence of postoperative complications or death after surgery (time frame: Within 90-days after the operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Jun 2017.