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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05901064
Other study ID # LinkoepingU
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 21, 2021
Est. completion date December 31, 2025

Study information

Verified date June 2023
Source University Hospital, Linkoeping
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Breast surgery plays an important role in the treatment of breast cancer. This study investigates if the use of Harmonic Focus has advantages than the use of conventional diathermy in axillary clearance due to metastatic breast cancer.


Description:

Breast surgery plays an important role in the treatment of breast cancer. Sometimes cancer cells can spread to lymph nodes in the axill. The first lymph node affected in the armpit is called the sentinel node. Surgery to remove this node can answer the question of whether the cancer has spread to the axill. If the node is affected, further surgery is performed to remove most of the lymph nodes in the armpit, a so-called axillary clereance. The breast unit at Linköping University Hospital performs about 60 axillary clereance per year. Axillary clereance is associated with a number of complications, such as infections, bleeding, pain, loss of sensation and limited mobility in the arm. Accumulation of wound fluid in the surgical area is common, affecting about a quarter of patients undergoing surgery. Small amounts of wound fluid usually do not require treatment, but larger accumulations usually require drainage. Patients who have symptoms from armpit wound fluid have to make repeated return visits so that a nurse drains the fluid using a needle. This poses several risks to the patient such as infection and/or bleeding. This, in turn, can delay the start of additional treatment and can put a financial burden on both the patient and the healthcare system. Today, the investigators use a device with a weak electric current (diathermy) to remove lymph nodes from the armpit. Harmonic Focus ® is a pair of scissors that instead uses ultrasound waves to divide the tissue. There are scientific studies showing that the use of ultrasonic scissors reduces the risk of fluid accumulation and thus the risk of complications after surgery[1, 2]. The investigators want to conduct a prospective study, an economic analysis comparing the costs of using diathermy versus Harmonic Focus®. In addition, patients will complete a quality of life questionnaire before surgery, approximately 4-6 weeks after and one year after surgery. The results of the questionnaires will be compared between the Harmonic Focus® and the diathermy group.


Recruitment information / eligibility

Status Recruiting
Enrollment 150
Est. completion date December 31, 2025
Est. primary completion date December 31, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 18 years or older - All patients who will undergo axillary evacuation - Informed consent Exclusion Criteria: - Patients who have previously undergone axillary evacuation.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Axillary clearance
Evaluating the use of Harmonic Focus in axillary clearance due to metastasis of breast cancer in axilla

Locations

Country Name City State
Sweden University hospital of Linkoping Linköping Östergötland

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Linkoeping

Country where clinical trial is conducted

Sweden, 

References & Publications (9)

Bohm D, Kubitza A, Lebrecht A, Schmidt M, Gerhold-Ay A, Battista M, Stewen K, Solbach C, Kolbl H. Prospective randomized comparison of conventional instruments and the Harmonic Focus((R)) device in breast-conserving therapy for primary breast cancer. Eur J Surg Oncol. 2012 Feb;38(2):118-24. doi: 10.1016/j.ejso.2011.11.003. Epub 2011 Dec 5. — View Citation

de Boniface J, Frisell J, Andersson Y, Bergkvist L, Ahlgren J, Ryden L, Olofsson Bagge R, Sund M, Johansson H, Lundstedt D; SENOMAC Trialists' Group. Survival and axillary recurrence following sentinel node-positive breast cancer without completion axillary lymph node dissection: the randomized controlled SENOMAC trial. BMC Cancer. 2017 May 26;17(1):379. doi: 10.1186/s12885-017-3361-y. — View Citation

Faisal M, Fathy H, Shaban H, Abuelela ST, Marie A, Khaled I. A novel technique of harmonic tissue dissection reduces seroma formation after modified radical mastectomy compared to conventional electrocautery: a single-blind randomized controlled trial. Patient Saf Surg. 2018 May 17;12:8. doi: 10.1186/s13037-018-0155-3. eCollection 2018. — View Citation

Galimberti V, Cole BF, Zurrida S, Viale G, Luini A, Veronesi P, Baratella P, Chifu C, Sargenti M, Intra M, Gentilini O, Mastropasqua MG, Mazzarol G, Massarut S, Garbay JR, Zgajnar J, Galatius H, Recalcati A, Littlejohn D, Bamert M, Colleoni M, Price KN, Regan MM, Goldhirsch A, Coates AS, Gelber RD, Veronesi U; International Breast Cancer Study Group Trial 23-01 investigators. Axillary dissection versus no axillary dissection in patients with sentinel-node micrometastases (IBCSG 23-01): a phase 3 randomised controlled trial. Lancet Oncol. 2013 Apr;14(4):297-305. doi: 10.1016/S1470-2045(13)70035-4. Epub 2013 Mar 11. Erratum In: Lancet Oncol. 2013 Jun;14(7):e254. — View Citation

Giuliano AE, Hunt KK, Ballman KV, Beitsch PD, Whitworth PW, Blumencranz PW, Leitch AM, Saha S, McCall LM, Morrow M. Axillary dissection vs no axillary dissection in women with invasive breast cancer and sentinel node metastasis: a randomized clinical trial. JAMA. 2011 Feb 9;305(6):569-75. doi: 10.1001/jama.2011.90. — View Citation

He Q, Zhuang D, Zheng L, Fan Z, Zhou P, Zhu J, Lv Z, Chai J, Cao L. Harmonic focus versus electrocautery in axillary lymph node dissection for breast cancer: a randomized clinical study. Clin Breast Cancer. 2012 Dec;12(6):454-8. doi: 10.1016/j.clbc.2012.07.014. Epub 2012 Oct 3. — View Citation

Hung SH, Chu D, Chen FM, Chen T, Chen RC. Evaluation of the harmonic scalpel in breast conserving and axillary staging surgery. J Chin Med Assoc. 2012 Oct;75(10):519-23. doi: 10.1016/j.jcma.2012.07.006. Epub 2012 Sep 15. — View Citation

Selvendran S, Cheluvappa R, Tr Ng VK, Yarrow S, Pang TC, Segara D, Soon P. Efficacy of harmonic focus scalpel in seroma prevention after axillary clearance. Int J Surg. 2016 Jun;30:116-20. doi: 10.1016/j.ijsu.2016.04.041. Epub 2016 Apr 29. — View Citation

Sowa Y, Numajiri T, Kawarazaki A, Sakaguchi K, Taguchi T, Nishino K. Preventive effects on seroma formation with use of the harmonic focus shears after breast reconstruction with the latissimus dorsi flap. J Plast Surg Hand Surg. 2016 Dec;50(6):349-353. doi: 10.1080/2000656X.2016.1178129. Epub 2016 May 5. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Economic comparison between the use of ultrasonic scissors and diathermy for axillary dissection in breast cancer patients. Unit of measures: Costs of extra visits with nurse, physiotherapist or surgeon, antibiotics, PICO, re-interventions due to complications, microbiological cultures, incapacity to work, hospitalizations 12 months
Secondary Function before and after breast cancer treatment. Lymph-ICF Survey Questionnaire 12 months
Secondary Complication frequency between the use of ultrasonic scissors and diathermy for axillary Comlplication frequency comparison 12 months
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