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Electrosurgical Bipolar Systems Versus Conventional Electrocautery After SLNBx

ConditionBreast Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age20-80
SponsorSMG-SNU Boramae Medical Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Electrosurgical bipolar systems groupExperimental treatment 1 intervention
Group B: Conventional electrocautery groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Drainage amount

Total drainage amount from axilla after surgery (ml)

Time frame
Up to four weeks

Secondary outcomes

1

Drainage amount during admission

Total drainage amount from axilla before discharge (ml)

Time frame
Up to one week
2

Operation time

Operation time during axillar surgery (min)

Time frame
Up to 2 hours
3

Complication

Complications of axilla

Time frame
At one month of surgery
4

Draine removal days

Days before drain removal (days)

Time frame
Up to two weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

SMG-SNU Boramae Medical Center

Lead sponsor

Source ClinicalTrials.gov
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