Breast CancerPhase 3ANDPreciseNCT02292407
Prospective Pilot Study ANDPrecise
A Phase 3 study testing LigaSure Precise instrument in people with Breast Cancer, run by The Netherlands Cancer Institute at 1 site in Netherlands.
Trial summary
This study aims at providing first evidence that axillary clearance by using an operation technique including the precise LigaSure instrument and closure of dead space of the axilla will result in an operation were a drain is not necessary and the need for seroma evacuation after surgery is very limited. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- LigaSure Precise instrument
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteNetherlands
- Study dates
- Jun 2012to Jun 2018
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Indications for axillary clearance can be a tumor positive sentinel node or tumor positive lymph nodes proven by ultrasound or fine needle aspiration cytology.
- For this pilot, only patients undergoing breast conserving surgery are eligible.
- Axillary clearance can be performed after previous sentinel node procedure, at the same operation, and after neo-adjuvant chemo therapy, and as secondary procedure in case of axillary relapse after previous treatment for breast cancer.
Who cannot join
- Patients undergoing a modified radical mastectomy including an axillary clearance.
- Preoperative preexisting seroma.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Netherlands Cancer Institute - Antoni van Leeuwenhoek
Amsterdam, 1066CX
Emiel Rutgers, MD, PHD, +3120512 ext. 2551, e.rutgers@nki.nl
About this study
Official title: AND Precise! : Axillary Lymph Node Dissection and No Drain With the PRECISE Instrument
This study aims at providing first evidence that axillary clearance by using an operation technique including the precise LigaSure instrument and closure of dead space of the axilla will result in an operation were a drain is not necessary and the need for seroma evacuation after surgery is very limited.
Read the detailed description
Axillary clearance in breast cancer is usually performed by using a drain to prevent seroma formation and to support obliteration of the dead space in the axillary carry out. The hypothesis made in this protocol is that axillary clearance by using an operation technique including the use of the precise LigaSure instrument and closure of dead space can be done without using a postoperative drain.
The AND PRECISE PROTOCOL aims at providing first evidence that axillary clearance by using an operation technique including the precise LigaSure instrument and closure of dead space of the axilla will result in an operation were a drain is not necessary and the need for seroma evacuation after surgery is very limited Patients undergoing axillary clearance necessary for achieving reasonable control in invasive breast cancer and participating in the AND PRECISE protocol will undergo the operation by using a technique including the use of the precise LigaSure instrument and closure of dead space. Postoperatively, the numbers of seroma punctions and the amount of seroma will be recorded prospectively. Patients will be asked to record on a daily basis their experience of pain by a visual analog scale of pain.
The main study parameter is the percent of cases which successfully did not need seroma punctions after the intervention.
Potential disadvantages for the patient are risk for more seroma formation and discomfort. Patients will be asked to record on a daily basis their experience of pain by a visual analog scale of pain.
- Conditions
- Breast Cancer
- Being tested
- LigaSure Precise instrument
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LigaSure Precise instrumentDevice
LigaSure Precise instrument is used during Axillary Lymph Node Dissection Technique: Dead space closure Technique: Omission of postoperative drain
| Study group | Role | What they receive |
|---|---|---|
| LigaSure Precise instrument | Experimental | ALND with use of LigaSure Precise instrument, closure of dead space, omission of a postoperative drain. Receives: Device: LigaSure Precise instrument |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of seroma evacuations per patient
Measured: within 3 months after surgery
Secondary outcomes (2)
Number of wound infections per patient
Measured: within 3 months after surgery
Number of hematomas per patient
Measured: within 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2014 (estimated)
- Study startJun 2012
- Primary completionJun 2017 (estimated)
- Study completionJun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by The Netherlands Cancer InstituteThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Netherlands Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emiel Rutgers, MD, PhD, Principal investigator, Netherlands Cancer Institute - Antoni van Leeuwenhoek
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02292407
- Sponsor's protocol ID
- N12PRE
- Acronym
- ANDPrecise
- Status last verified
- Oct 2014
- First submitted
- 27 Oct 2014
- Last updated
- 17 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
van Bemmel AJ, van de Velde CJ, Schmitz RF, Liefers GJ. Prevention of seroma formation after axillary dissection in breast cancer: a systematic review. Eur J Surg Oncol. 2011 Oct;37(10):829-35. doi: 10.1016/j.ejso.2011.04.012. Epub 2011 Aug 17.
PubMed 21849243Baas-Vrancken Peeters MJ, Kluit AB, Merkus JW, Breslau PJ. Short versus long-term postoperative drainage of the axilla after axillary lymph node dissection. A prospective randomized study. Breast Cancer Res Treat. 2005 Oct;93(3):271-5. doi: 10.1007/s10549-005-5348-7.
PubMed 16172795Classe JM, Berchery D, Campion L, Pioud R, Dravet F, Robard S. Randomized clinical trial comparing axillary padding with closed suction drainage for the axillary wound after lymphadenectomy for breast cancer. Br J Surg. 2006 Jul;93(7):820-4. doi: 10.1002/bjs.5433.
PubMed 16775817Ostapoff KT, Euhus D, Xie XJ, Rao M, Moldrem A, Rao R. Axillary lymph node dissection for breast cancer utilizing Harmonic Focus(R). World J Surg Oncol. 2011 Aug 15;9:90. doi: 10.1186/1477-7819-9-90.
PubMed 21843361Gong Y, Xu J, Shao J, Cheng H, Wu X, Zhao D, Xiong B. Prevention of seroma formation after mastectomy and axillary dissection by lymph vessel ligation and dead space closure: a randomized trial. Am J Surg. 2010 Sep;200(3):352-6. doi: 10.1016/j.amjsurg.2009.10.013. Epub 2010 Apr 20.
PubMed 20409509
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AND Precise! : Axillary Lymph Node Dissection and No Drain With the PRECISE Instrument
- ClinicalTrials.gov ID
- NCT02292407
- Acronym / sponsor ID
- ANDPrecise / N12PRE
- Conditions
- Breast Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- The Netherlands Cancer InstituteUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 17 Nov 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.
This study aims at providing first evidence that axillary clearance by using an operation technique including the precise LigaSure instrument and closure of dead space of the axilla will result in an operation were a drain is not necessary and the need for seroma evacuation after surgery is very limited.
Detailed description
Axillary clearance in breast cancer is usually performed by using a drain to prevent seroma formation and to support obliteration of the dead space in the axillary carry out. The hypothesis made in this protocol is that axillary clearance by using an operation technique including the use of the precise LigaSure instrument and closure of dead space can be done without using a postoperative drain.
The AND PRECISE PROTOCOL aims at providing first evidence that axillary clearance by using an operation technique including the precise LigaSure instrument and closure of dead space of the axilla will result in an operation were a drain is not necessary and the need for seroma evacuation after surgery is very limited Patients undergoing axillary clearance necessary for achieving reasonable control in invasive breast cancer and participating in the AND PRECISE protocol will undergo the operation by using a technique including the use of the precise LigaSure instrument and closure of dead space. Postoperatively, the numbers of seroma punctions and the amount of seroma will be recorded prospectively. Patients will be asked to record on a daily basis their experience of pain by a visual analog scale of pain.
The main study parameter is the percent of cases which successfully did not need seroma punctions after the intervention.
Potential disadvantages for the patient are risk for more seroma formation and discomfort. Patients will be asked to record on a daily basis their experience of pain by a visual analog scale of pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LigaSure Precise instrument | Experimental | Device: LigaSure Precise instrumentALND with use of LigaSure Precise instrument, closure of dead space, omission of a postoperative drain. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Indications for axillary clearance can be a tumor positive sentinel node or tumor positive lymph nodes proven by ultrasound or fine needle aspiration cytology.
- For this pilot, only patients undergoing breast conserving surgery are eligible.
- Axillary clearance can be performed after previous sentinel node procedure, at the same operation, and after neo-adjuvant chemo therapy, and as secondary procedure in case of axillary relapse after previous treatment for breast cancer.
Key exclusion criteria (2 listed)
- Patients undergoing a modified radical mastectomy including an axillary clearance.
- Preoperative preexisting seroma.
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 |
|---|---|---|
| LigaSure Precise instrumentLigaSure Precise instrument is used during Axillary Lymph Node Dissection Technique: Dead space closure Technique: Omission of postoperative drain | Device | LigaSure Precise instrument |
Primary outcome
Number of seroma evacuations per patient
Time frame: within 3 months after surgery
2 secondary outcomes
Number of wound infections per patient
Time frame: within 3 months after surgery
Number of hematomas per patient
Time frame: within 3 months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2014.
- Background: PubMed 21849243van Bemmel AJ, van de Velde CJ, Schmitz RF, Liefers GJ. Prevention of seroma formation after axillary dissection in breast cancer: a systematic review. Eur J Surg Oncol. 2011 Oct;37(10):829-35. doi: 10.1016/j.ejso.2011.04.012. Epub 2011 Aug 17.
- Background: PubMed 16172795Baas-Vrancken Peeters MJ, Kluit AB, Merkus JW, Breslau PJ. Short versus long-term postoperative drainage of the axilla after axillary lymph node dissection. A prospective randomized study. Breast Cancer Res Treat. 2005 Oct;93(3):271-5. doi: 10.1007/s10549-005-5348-7.
- Background: PubMed 16775817Classe JM, Berchery D, Campion L, Pioud R, Dravet F, Robard S. Randomized clinical trial comparing axillary padding with closed suction drainage for the axillary wound after lymphadenectomy for breast cancer. Br J Surg. 2006 Jul;93(7):820-4. doi: 10.1002/bjs.5433.
- Background: PubMed 21843361Ostapoff KT, Euhus D, Xie XJ, Rao M, Moldrem A, Rao R. Axillary lymph node dissection for breast cancer utilizing Harmonic Focus(R). World J Surg Oncol. 2011 Aug 15;9:90. doi: 10.1186/1477-7819-9-90.
- Background: PubMed 20409509Gong Y, Xu J, Shao J, Cheng H, Wu X, Zhao D, Xiong B. Prevention of seroma formation after mastectomy and axillary dissection by lymph vessel ligation and dead space closure: a randomized trial. Am J Surg. 2010 Sep;200(3):352-6. doi: 10.1016/j.amjsurg.2009.10.013. Epub 2010 Apr 20.
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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.
Emiel Rutgers, MD, PhD principal investigator
Netherlands Cancer Institute - Antoni van Leeuwenhoek
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 LigaSure Precise instrument in people with Breast Cancer, run by The Netherlands Cancer Institute at 1 site in Netherlands.
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 3 inclusion and 2 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 17 Nov 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 Netherlands. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Emiel Rutgers, MD, PhD (+3120512 ext. 2551, e.rutgers@nki.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of seroma evacuations per patient (time frame: within 3 months after surgery). 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 NCT02292407, which also lists 5 linked publications.
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 17 Nov 2014.