Breast CancerNCT06426810
Electrosurgical Bipolar Systems Versus Conventional Electrocautery After SLNBx
A study testing Electrosurgical bipolar system (LigaSure) in people with Breast Cancer, run by SMG-SNU Boramae Medical Center at 1 site in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 80 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Electrosurgical bipolar system (LigaSure)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- 7 May 2024to 7 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
SMG-SNU Boramae medical center
Seoul, Dongjak-gu, 07061
Jong-Ho Cheun, M.S., +82-10-8754-3054, chun89aaa@naver.com
About this study
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
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.
Read the 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
- Breast Cancer
- Being tested
- Electrosurgical bipolar system (LigaSure)
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Drainage amount
Total drainage amount from axilla after surgery (ml)
Measured: Up to four weeks
Secondary outcomes (4)
Drainage amount during admission
Total drainage amount from axilla before discharge (ml)
Measured: Up to one week
Operation time
Operation time during axillar surgery (min)
Measured: Up to 2 hours
Complication
Complications of axilla
Measured: At one month of surgery
Draine removal days
Days before drain removal (days)
Measured: Up to two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2024
- Study start7 May 2024
- Primary completion7 Apr 2027 (estimated)
- Study completion7 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SMG-SNU Boramae Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jong-Ho Cheun, SMG-SNU Boramae Medical Center
- Investigators
- Jong-Ho Cheun, M.S., Principal investigator, SMG-SNU Boramae Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06426810
- Sponsor's protocol ID
- 10-2024-18
- Status last verified
- May 2024
- First submitted
- 7 May 2024
- Last updated
- 23 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 21849243Manouras 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.
PubMed 18559751Nespoli 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.
PubMed 22959311Cortadellas 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.
PubMed 21925293Miyagi 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.
PubMed 25682592Park 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.
PubMed 35914746
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06426810
- Acronym / sponsor ID
- 10-2024-18
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- SMG-SNU Boramae Medical CenterUniversity, hospital or other
- Study start
- 7 May 2024 (actual)
- Primary completion
- 7 Apr 2027 (estimated)
- Study completion
- 7 Apr 2027 (estimated)
- First posted
- 23 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Electrosurgical bipolar systems group | Experimental | Device: Electrosurgical bipolar system (LigaSure)Study participants using a electrosurgical bipolar energy system will undergo sentinel lymph node biopsy using only LigaSure during the surgery. |
| Conventional electrocautery group | No intervention | –Study participants using a conventional electrocautery will undergo sentinel lymph node biopsy using conventional bovie electrocautery during the surgery. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electrosurgical bipolar system (LigaSure)Study participants using a electrosurgical bipolar energy system will undergo sentinel lymph node biopsy using only LigaSure during the surgery. | Device | Electrosurgical bipolar systems group |
Primary outcome
Drainage amount
Time frame: Up to four weeks
Total drainage amount from axilla after surgery (ml)
4 secondary outcomes
Drainage amount during admission
Time frame: Up to one week
Operation time
Time frame: Up to 2 hours
Complication
Time frame: At one month of surgery
Draine removal days
Time frame: Up to two weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2024.
- Background: PubMed 21849243van 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.
- Background: PubMed 18559751Manouras 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.
- Background: PubMed 22959311Nespoli 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.
- Background: PubMed 21925293Cortadellas 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.
- Background: PubMed 25682592Miyagi 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.
- Background: PubMed 35914746Park 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jong-Ho Cheun, M.S. principal investigator
SMG-SNU Boramae Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electrosurgical bipolar system (LigaSure) in people with Breast Cancer, run by SMG-SNU Boramae Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jong-Ho Cheun, M.S. (+82-10-8754-3054, chun89aaa@naver.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Drainage amount (time frame: Up to four weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06426810, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2024.