## Protocol Section
### Identification Module
**NCT ID:** NCT06426810

**Brief Title:** Electrosurgical Bipolar Systems Versus Conventional Electrocautery After SLNBx

**Official Title:** A Prospective Randomized Study Comparing Electrosurgical Bipolar Systems Versus Conventional Electrocautery After Sentinel Lymph Node Biopsy in Obese or Preoperative Chemotherapy Treated Breast Cancer Patients

#### Organization Study ID Info
**ID:** 10-2024-18
#### Organization
**Class:** OTHER
**Full Name:** SMG-SNU Boramae Medical Center
### Status Module
#### Completion Date
**Date:** 2027-04-07

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-23

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-17

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2027-04-07

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-07

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-07
**Study First Submit QC Date:** 2024-05-17
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** SMG-SNU Boramae Medical Center

#### Responsible Party

**Investigator Affiliation:** SMG-SNU Boramae Medical Center

**Investigator Full Name:** Jong-Ho Cheun

**Investigator Title:** Clinical Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**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.

**Detailed Description:** The most common complications of breast cancer surgery are lymphorrhea and seroma. Seroma increases the length of hospital stay, the duration of outpatient treatment, and patient discomfort. Persistent seroma can lead to re-hospitalization due to wound infection caused by repeated aspirations. Seroma generally occurs in 10% to 85% of cases after breast cancer surgery. Risk factors associated with seroma or lymphorrhea identified in previous studies include age over 60, high BMI, tumor size, preoperative chemotherapy, extent of breast tissue resection, number of lymph nodes removed, and number of lymph node metastases.

Efforts to reduce seroma after breast cancer surgery include meticulous techniques such as sharp dissection, the use of monopolar energy devices, and ligation of blood vessels and lymphatics. Recently, the bipolar energy sealing system has been increasingly used. LigaSure, which uses electric energy and pressure to denature collagen and elastin in tissue, has been shown to reduce surgical time and medical costs compared to traditional clamp-and-tie methods and advanced sealing systems in various surgeries, including breast cancer.

In breast cancer surgery, using a electrosurgical bipolar systems for ligating blood vessels and lymph nodes has several potential advantages. Traditional ligation using sutures or monopolar energy devices can be influenced by surgical technique and has drawbacks such as thermal injury to surrounding tissue. In contrast, the bipolar energy sealer applies both electric energy and pressure simultaneously, minimizing thermal injury to surrounding tissue while ensuring permanent vessel and lymphatic ligation.

A 2008 prospective study showed that using bipolar energy sealers in axillary dissection allowed for earlier removal of drains compared to conventional methods. Other studies have shown less blood loss, lower drainage output, and shorter hospital stays during surgery. Recent research has also reported new applications of bipolar energy sealers in skin-sparing mastectomy, indicating active use in breast surgery overseas. A study conducted at Severance Hospital in South Korea found that using bipolar energy sealers reduced drainage.

However, most of these studies were conducted abroad with a small number of reported cases, and the results mainly concern axillary lymph node dissection (ALND), which is where seroma is most often formed. With the decreasing trend of ALND due to advances in preoperative chemotherapy and radiotherapy, there is a lack of studies on whether using electrosurgical bipolar systems helps reduce seroma formation after sentinel lymph node biopsy.

### Conditions Module

**Conditions:**

- Breast Cancer

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- PARTICIPANT

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 40

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

- Device: Electrosurgical bipolar system (LigaSure)

**Label:** Electrosurgical bipolar systems group

**Type:** EXPERIMENTAL

#### Arm Group 2

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

**Label:** Conventional electrocautery group

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Electrosurgical bipolar systems group

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

**Name:** Electrosurgical bipolar system (LigaSure)

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** Total drainage amount from axilla after surgery (ml)

**Measure:** Drainage amount

**Time Frame:** Up to four weeks

#### Secondary Outcomes

**Description:** Total drainage amount from axilla before discharge (ml)

**Measure:** Drainage amount during admission

**Time Frame:** Up to one week

**Description:** Operation time during axillar surgery (min)

**Measure:** Operation time

**Time Frame:** Up to 2 hours

**Description:** Complications of axilla

**Measure:** Complication

**Time Frame:** At one month of surgery

**Description:** Days before drain removal (days)

**Measure:** Draine removal days

**Time Frame:** Up to two weeks

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

**Maximum Age:** 80 Years

**Minimum Age:** 20 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** chun89aaa@naver.com

**Name:** Jong-Ho Cheun, M.S.

**Phone:** +82-10-8754-3054

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Seoul

**Contacts:**

***Contact 1:***

- **Email:** chun89aaa@naver.com

- **Name:** Jong-Ho Cheun, M.S.

- **Phone:** +82-10-8754-3054

- **Role:** CONTACT

**Country:** Korea, Republic of

**Facility:** SMG-SNU Boramae medical center

**State:** Dongjak-gu

**Status:** RECRUITING

**Zip:** 07061

#### Overall Officials

**Official 1:**

**Affiliation:** SMG-SNU Boramae Medical Center

**Name:** Jong-Ho Cheun, M.S.

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### 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.

**PMID:** 21849243

**Citation:** 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:** 18559751

**Citation:** 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:** 22959311

**Citation:** 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:** 21925293

**Citation:** 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:** 25682592

**Citation:** 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:** 35914746

## Document Section

### Large Document Module

#### Large Docs

- Date: 2024-04-19

- Filename: Prot_SAP_000.pdf

- Has ICF: False

- Has Protocol: True

- Has SAP: True

- Label: Study Protocol and Statistical Analysis Plan

- Size: 153614

- Type Abbrev: Prot_SAP

- Upload Date: 2024-05-17T07:38

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000009369

- Term: Neoplasms

- ID: D000001941

- Term: Breast Diseases

- ID: D000012871

- Term: Skin Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

### Condition Browse Module - Browse Leaves

- ID: M12701

- Name: Obesity

- Relevance: LOW

- As Found: Unknown

- ID: M5220

- Name: Breast Neoplasms

- Relevance: HIGH

- As Found: Breast Cancer

- ID: M5218

- Name: Breast Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M15674

- Name: Skin Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000001943

- Term: Breast Neoplasms

### Misc Info Module

- Version Holder: 2024-05-31
