TumorsNCT00553033
Laparoscopic Liver Resection
An observational study of Tumors, run by IRCCS San Raffaele at 1 site in Italy.
Trial summary
The aim of this study is to evaluate the feasibility and safety of laparoscopic liver surgery. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Tumors
- What is being tested?
- Laparoscopic liver surgery
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- Sep 2005to Dec 2008
- 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: Patients udergoing liver resection for benign or malignant tumors
Who may be able to join
- benign or malignant tumors
- tumor size less than 12 cm
Who cannot join
- Operations that required laparotomic procedures
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Department of Surgery - Liver Unit, Scientific Institute San Raffaele
Milan, Milan, 20132
Luca Aldrighetti, M.D PhD, +39-02-2643-7808, aldrighetti.luca@hsr.it
About this study
Official title: Prospective Evaluation of Laparoscopic Liver Resection
The aim of this study is to evaluate the feasibility and safety of laparoscopic liver surgery.
Read the detailed description
Perioperative course of patients undergoing liver resection is evaluated.
- Conditions
- Tumors
- Being tested
- Laparoscopic liver surgery
- Keywords
- Patients must be candidable to liver resection
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic liver surgeryProcedure or surgery
Ultrasonic dissector, harmonic scalpel
| Study group | Role | What they receive |
|---|---|---|
| A | Not described Receives: Procedure: Laparoscopic liver surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perioperative Morbidity and mortality
Measured: Perioperative
Secondary outcomes (2)
Patient satisfation
Measured: Perioperative
Patients satisfaction
Measured: Postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2007 (estimated)
- Study startSep 2005
- Study completionDec 2008 (estimated)
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 TumorsStudies 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
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Investigators
- Luca Aldrighetti, M.D PhD, Study director, Department of Surgery - Liver Unit, Scientific Institute San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00553033
- Sponsor's protocol ID
- LPSLIVER1
- Status last verified
- Oct 2007
- First submitted
- 1 Nov 2007
- Last updated
- 2 Nov 2007
- Results posted
- No
Publications
Aldrighetti L, Pulitano C, Catena M, Arru M, Guzzetti E, Casati M, Comotti L, Ferla G. A prospective evaluation of laparoscopic versus open left lateral hepatic sectionectomy. J Gastrointest Surg. 2008 Mar;12(3):457-62. doi: 10.1007/s11605-007-0244-6. Epub 2007 Aug 14.
PubMed 17701265
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of Laparoscopic Liver Resection
- ClinicalTrials.gov ID
- NCT00553033
- Acronym / sponsor ID
- LPSLIVER1
- Conditions
- Tumors
- Keywords
- Patients must be candidable to liver resection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- Sep 2005
- Study completion
- Dec 2008 (estimated)
- First posted
- 2 Nov 2007 (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.
The aim of this study is to evaluate the feasibility and safety of laparoscopic liver surgery.
Detailed description
Perioperative course of patients undergoing liver resection is evaluated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | – | Procedure: Laparoscopic liver surgery |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients udergoing liver resection for benign or malignant tumors
Key inclusion criteria (2 listed)
- benign or malignant tumors
- tumor size less than 12 cm
Key exclusion criteria (1 listed)
- Operations that required laparotomic procedures
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 |
|---|---|---|
| Laparoscopic liver surgeryUltrasonic dissector, harmonic scalpel | Procedure or surgery | A |
Primary outcome
Perioperative Morbidity and mortality
Time frame: Perioperative
2 secondary outcomes
Patient satisfation
Time frame: Perioperative
Patients satisfaction
Time frame: Postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2007.
- Results publication: PubMed 17701265Aldrighetti L, Pulitano C, Catena M, Arru M, Guzzetti E, Casati M, Comotti L, Ferla G. A prospective evaluation of laparoscopic versus open left lateral hepatic sectionectomy. J Gastrointest Surg. 2008 Mar;12(3):457-62. doi: 10.1007/s11605-007-0244-6. Epub 2007 Aug 14.
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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.
Luca Aldrighetti, M.D PhD study director
Department of Surgery - Liver Unit, Scientific Institute San Raffaele
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 Tumors, run by IRCCS San Raffaele 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 2 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: status not confirmed, as of the sponsor's last update on 2 Nov 2007. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Luca Aldrighetti, M.D, PhD (390226437806, aldrighetti.luca@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perioperative Morbidity and mortality (time frame: Perioperative). 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 NCT00553033, 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 2 Nov 2007.