Clinical trial NCT02292407: Prospective Pilot Study ANDPrecise
Official title: AND Precise! : Axillary Lymph Node Dissection and No Drain With the PRECISE Instrument
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Breast Cancer
Lead sponsor: The Netherlands Cancer Institute
Sponsor class: OTHER
First posted: 2014-11-17
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of seroma evacuations per patient
timeFrame: within 3 months after surgery
Secondary outcomes:
measure: Number of wound infections per patient
timeFrame: within 3 months after surgery
measure: Number of hematomas per patient
timeFrame: within 3 months after surgery
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Netherlands Cancer Institute - Antoni van Leeuwenhoek
Study officials:
affiliation: Netherlands Cancer Institute - Antoni van Leeuwenhoek
name: Emiel Rutgers, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Baas-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.
citation: Classe 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.
citation: Ostapoff 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.
citation: Gong 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.