NCT02292407

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for phase_3 breast-cancer

Timeline
Completed

Started Jun 2012

Typical duration for phase_3 breast-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

October 27, 2014

Completed
21 days until next milestone

First Posted

Study publicly available on registry

November 17, 2014

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

November 17, 2014

Status Verified

October 1, 2014

Enrollment Period

5 years

First QC Date

October 27, 2014

Last Update Submit

November 12, 2014

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • Number of seroma evacuations per patient

    within 3 months after surgery

Secondary Outcomes (2)

  • Number of wound infections per patient

    within 3 months after surgery

  • Number of hematomas per patient

    within 3 months after surgery

Study Arms (1)

LigaSure Precise instrument

EXPERIMENTAL

ALND with use of LigaSure Precise instrument, closure of dead space, omission of a postoperative drain.

Device: LigaSure Precise instrument

Interventions

LigaSure Precise instrumentDEVICE

LigaSure Precise instrument is used during Axillary Lymph Node Dissection Technique: Dead space closure Technique: Omission of postoperative drain

LigaSure Precise instrument

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Patients undergoing a modified radical mastectomy including an axillary clearance.
  • Preoperative preexisting seroma.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Netherlands Cancer Institute - Antoni van Leeuwenhoek

Amsterdam, 1066CX, Netherlands

RECRUITING

Related Publications (5)

  • 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.

    PMID: 21849243BACKGROUND

  • 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.

    PMID: 16172795BACKGROUND

  • 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.

    PMID: 16775817BACKGROUND

  • 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.

    PMID: 21843361BACKGROUND

  • 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.

    PMID: 20409509BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Emiel Rutgers, MD, PhD

    Netherlands Cancer Institute - Antoni van Leeuwenhoek

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Emiel Rutgers, MD, PhD

CONTACT

+3120512e.rutgers@nki.nl

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 27, 2014

First Posted

November 17, 2014

Study Start

June 1, 2012

Primary Completion

June 1, 2017

Study Completion

June 1, 2018

Last Updated

November 17, 2014

Record last verified: 2014-10

Locations

NL(1)