Axilla Node DissectionPhase 3NCT01286337
Axillary Lymphadenectomy. A Randomized Trial Comparing Bipolar Vessel Sealing To Conventional Technique
A Phase 3 study testing bipolar vessel sealing in people with Axilla Node Dissection, run by University of Milano Bicocca at 1 site in Italy.
Trial summary
lymphorrehea remains the most frequent complication after axillary lymphadenectomy. we hyphothesize that the use of a bipolar vessel sealing may reduce the rate of lymph collection compared to the traditional surgical technique Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Axilla Node Dissection
- What is being tested?
- bipolar vessel sealing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteItaly
- Study dates
- Apr 2009to Jan 2011
- Phase
- Phase 3
- 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 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women with documented breast cancer (by histology or cytology) and candidate to elective axillary lymphadenectomy
Who cannot join
- Age less than 18 years
- Denied written informed content
- Previous axillary operations (except for sentinel node biopsy)
- Preoperative radio-chemotherapy
- Scheduled reconstructive breast operation
Trial locations and contacts
1 site in 1 country.
About this study
lymphorrehea remains the most frequent complication after axillary lymphadenectomy. we hyphothesize that the use of a bipolar vessel sealing may reduce the rate of lymph collection compared to the traditional surgical technique
- Conditions
- Axilla Node Dissection
- Being tested
- bipolar vessel sealing, control
- Keywords
- axilla, surgery, technique, bipolar vessel sealing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bipolar vessel sealingProcedure or surgery
controlProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| vessel sealing | Experimental | axilla dissection using this device Receives: Procedure: bipolar vessel sealing |
| control | Active comparator | standard surgical technique Receives: Procedure: control |
What is being measured
The primary outcome is the main question the study is designed to answer.
reduction of lymphorrhea rate
Measured: forth postoperative day
Secondary outcomes (1)
reduction of lymph output from the axillary drain
Measured: forth postoperative days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2011 (estimated)
- Study startApr 2009
- Primary completionMar 2010
- Study completionJan 2011
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 Axilla Node DissectionStudies 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Milano Bicocca
- Sponsor type
- University, hospital or other
- Investigators
- angelo nespoli, md, Study director, milano-bicocca universityluca gianotti, md, Principal investigator, milano-bicocca university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01286337
- Sponsor's protocol ID
- ligasure
- Other IDs
- ligamonza
- Status last verified
- Aug 2010
- First submitted
- 19 Jan 2011
- Last updated
- 31 Jan 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Nespoli L, Antolini L, Stucchi C, Nespoli A, Valsecchi MG, Gianotti L. Axillary lymphadenectomy for breast cancer. A randomized controlled trial comparing a bipolar vessel sealing system to the conventional technique. Breast. 2012 Dec;21(6):739-45. doi: 10.1016/j.breast.2012.08.003. Epub 2012 Sep 7.
PubMed 22959311
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Axillary Lymphadenectomy. A Randomized Trial Comparing Bipolar Vessel Sealing To Conventional Technique
- ClinicalTrials.gov ID
- NCT01286337
- Acronym / sponsor ID
- ligasure
- Conditions
- Axilla Node Dissection
- Keywords
- axilla, surgery, technique, bipolar vessel sealing
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- University of Milano BicoccaUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Mar 2010 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 31 Jan 2011 (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.
lymphorrehea remains the most frequent complication after axillary lymphadenectomy. we hyphothesize that the use of a bipolar vessel sealing may reduce the rate of lymph collection compared to the traditional surgical technique
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| vessel sealing | Experimental | Procedure: bipolar vessel sealingaxilla dissection using this device |
| control | Active comparator | Procedure: controlstandard surgical technique |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Women with documented breast cancer (by histology or cytology) and candidate to elective axillary lymphadenectomy
Key exclusion criteria (5 listed)
- Age less than 18 years
- Denied written informed content
- Previous axillary operations (except for sentinel node biopsy)
- Preoperative radio-chemotherapy
- Scheduled reconstructive breast operation
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 |
|---|---|---|
| bipolar vessel sealing | Procedure or surgery | vessel sealing |
| control | Procedure or surgery | control |
Primary outcome
reduction of lymphorrhea rate
Time frame: forth postoperative day
1 secondary outcome
reduction of lymph output from the axillary drain
Time frame: forth postoperative 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 31 Jan 2011.
- Derived from this study: PubMed 22959311Nespoli L, Antolini L, Stucchi C, Nespoli A, Valsecchi MG, Gianotti L. Axillary lymphadenectomy for breast cancer. A randomized controlled trial comparing a bipolar vessel sealing system to the conventional technique. Breast. 2012 Dec;21(6):739-45. doi: 10.1016/j.breast.2012.08.003. Epub 2012 Sep 7.
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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.
angelo nespoli, md study director
milano-bicocca university
luca gianotti, md principal investigator
milano-bicocca university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing bipolar vessel sealing in people with Axilla Node Dissection, run by University of Milano Bicocca 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 5 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 31 Jan 2011. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
reduction of lymphorrhea rate (time frame: forth postoperative day). 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 NCT01286337, 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 31 Jan 2011.