NCT06426810

Brief Summary

The efficacy of electrosurgical bipolar systems in axillary lymph node dissection for breast cancer surgery is well known. In this study, the investigators aim to determine whether using electrosurgical bipolar systems helps reduce seroma formation in high-risk patients undergoing sentinel lymph node biopsy (SLNB) for breast cancer surgery. The investigators will focus on patients who are expected to experience high drainage output after SLNB, especially those who are obese (BMI\>25) or have undergone preoperative chemotherapy.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable breast-cancer

Timeline
9mo left

Started May 2024

Typical duration for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress77%
May 2024Apr 2027

First Submitted

Initial submission to the registry

May 7, 2024

Completed
Same day until next milestone

Study Start

First participant enrolled

May 7, 2024

Completed
16 days until next milestone

First Posted

Study publicly available on registry

May 23, 2024

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 7, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 7, 2027

Last Updated

May 23, 2024

Status Verified

May 1, 2024

Enrollment Period

2.9 years

First QC Date

May 7, 2024

Last Update Submit

May 17, 2024

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • Drainage amount

    Total drainage amount from axilla after surgery (ml)

    Up to four weeks

Secondary Outcomes (4)

  • Drainage amount during admission

    Up to one week

  • Operation time

    Up to 2 hours

  • Complication

    At one month of surgery

  • Draine removal days

    Up to two weeks

Study Arms (2)

Electrosurgical bipolar systems group

EXPERIMENTAL

Study participants using a electrosurgical bipolar energy system will undergo sentinel lymph node biopsy using only LigaSure during the surgery.

Device: Electrosurgical bipolar system (LigaSure)

Conventional electrocautery group

NO INTERVENTION

Study participants using a conventional electrocautery will undergo sentinel lymph node biopsy using conventional bovie electrocautery during the surgery.

Interventions

Electrosurgical bipolar system (LigaSure)DEVICE

Study participants using a electrosurgical bipolar energy system will undergo sentinel lymph node biopsy using only LigaSure during the surgery.

Electrosurgical bipolar systems group

Eligibility Criteria

Age20 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women aged 20-80
  • Candidates for breast-conserving surgery and axillary sentinel lymph node biopsy
  • BMI over 25 or those who have received preoperative chemotherapy
  • Overall performance status of Eastern Cooperative Oncology Group (ECOG) 0-2
  • Participants who understand the study contents and can provide written consent
  • Participants without evidence of distant metastasis

You may not qualify if:

  • Those with suspected axillary lymph node enlargement or metastasis on preoperative imaging (breast MRI, chest CT, breast ultrasound)
  • Among patients who had confirmed lymph node metastasis before neoadjuvant chemotherapy, whose preopreative image showed residual disease at axillary lymph node
  • Those planning for mastectomy
  • Those planning for axillary lymph node dissection without SLNBx
  • Male breast cancer patients
  • Patients with bilateral breast cancer
  • Illiterate individuals, foreigners, or others who cannot read or understand the consent form
  • Individuals who voluntarily decide not to participate in the study or do not sign the consent form
  • Those judged by the researcher to be inappropriate for participation in this study
  • Study participants who did not have a drain inserted in the surgical area
  • If the randomized device is not used due to surgical room conditions (e.g., unavailability due to other emergency surgeries, device malfunction) and another device is substituted

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SMG-SNU Boramae medical center

Seoul, Dongjak-gu, 07061, South Korea

RECRUITING

Related Publications (6)

  • 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

  • Manouras A, Markogiannakis H, Genetzakis M, Filippakis GM, Lagoudianakis EE, Kafiri G, Filis K, Zografos GC. Modified radical mastectomy with axillary dissection using the electrothermal bipolar vessel sealing system. Arch Surg. 2008 Jun;143(6):575-80; discussion 581. doi: 10.1001/archsurg.143.6.575.

    PMID: 18559751BACKGROUND

  • 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.

    PMID: 22959311BACKGROUND

  • Cortadellas T, Cordoba O, Espinosa-Bravo M, Mendoza-Santin C, Rodriguez-Fernandez J, Esgueva A, Alvarez-Vinuesa M, Rubio IT, Xercavins J. Electrothermal bipolar vessel sealing system in axillary dissection: a prospective randomized clinical study. Int J Surg. 2011;9(8):636-40. doi: 10.1016/j.ijsu.2011.08.002. Epub 2011 Sep 10.

    PMID: 21925293BACKGROUND

  • Miyagi K, Rossi SH, Malata CM, Forouhi P. Novel use of LigaSure Impact electrosurgical bipolar vessel sealing system in skin-sparing mastectomy. J Plast Reconstr Aesthet Surg. 2015 Jun;68(6):e126-8. doi: 10.1016/j.bjps.2015.01.005. Epub 2015 Jan 26. No abstract available.

    PMID: 25682592BACKGROUND

  • Park HS, Lee J, Kim JY, Park JM, Kwon Y. A Prospective Randomized Study to Compare Postoperative Drainage After Mastectomy Using Electrosurgical Bipolar Systems and Conventional Electro-Cautery. J Breast Cancer. 2022 Aug;25(4):307-317. doi: 10.4048/jbc.2022.25.e29. Epub 2022 Jun 27.

    PMID: 35914746BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Jong-Ho Cheun, M.S.

    SMG-SNU Boramae Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jong-Ho Cheun, M.S.

CONTACT

+82-10-8754-3054chun89aaa@naver.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

May 7, 2024

First Posted

May 23, 2024

Study Start

May 7, 2024

Primary Completion (Estimated)

April 7, 2027

Study Completion (Estimated)

April 7, 2027

Last Updated

May 23, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)