Clinical trial · Interventional
Prospective Pilot Study ANDPrecise
AND Precise! : Axillary Lymph Node Dissection and No Drain With the PRECISE Instrument
NCT02292407CI-TRIAL-00016086ANDPreciseunknownPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| LigaSure Precise instrument | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- LigaSure Precise instrument
- description
- ALND with use of LigaSure Precise instrument, closure of dead space, omission of a postoperative drain.
- interventionNames
- Device: LigaSure Precise instrument
Primary outcomes (1)
- measure
- Number of seroma evacuations per patient
- timeFrame
- within 3 months after surgery
Secondary outcomes (2)
- measure
- Number of wound infections per patient
- timeFrame
- within 3 months after surgery
- measure
- Number of hematomas per patient
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * Patients undergoing a modified radical mastectomy including an axillary clearance. * Preoperative preexisting seroma.
References
Publications (5)
- BACKGROUNDvan 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. PMID 21849243
- BACKGROUNDBaas-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. PMID 16172795
- BACKGROUNDClasse 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. PMID 16775817
- BACKGROUNDOstapoff 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. PMID 21843361
- BACKGROUNDGong 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. PMID 20409509