To reduce the extent of healthy breast tissue resection by US-guided surgery for palpable tumours compared to traditional palpation-guided surgery, without compromising oncological principles. To improve cosmetic outcomes and quality of life by US-…
Source
Brief title
Condition
- Breast therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
No registrations found.
Outcome measures
Primary outcome
Primary outcome parameters are the volume of resected breast tissue excised
(compared to the optimal resected volume) and the oncological margin status.
Secondary outcome
Secondary outcome parameters are cosmetic outcomes and quality of life.
Background summary
Breast-conserving therapy (BCT) for breast cancer is initiated as a method to
preserve healthy breast tissue, thereby improving cosmetic outcomes. The
cosmetic outcome after breast cancer surgery is an important determinant of
patient satisfaction, maintenance of self-image and quality of life. Thus far,
the primary aim of BCT has been focused on achieving tumour-free resection
margins and preventing local recurrence, while the cosmetic outcome has been
considered less important.
Large studies have reported poor cosmetic outcomes in 20-40% of patients after
BCT, and the volume of resected breast tissue is the major determinant of the
cosmetic outcome. In daily practice, surgical resection of palpable breast
cancer is performed with guidance by intra-operative palpation. Concerns about
tumour involvement of resection margins, however, often result in unnecessarily
wide resection of adjacent healthy breast tissue. Our recent large multicentre
retrospective study showed that in 32% (112/351) of patients over 200%
excessive healthy breast tissue was excised with the malignant tissue! The mean
volume excessively excised was 142 cm³ (64-423 cm³; sd 86)!
There is clear evidence for the efficacy of ultrasonography (US) in the
resection of nonpalpable tumours, and US is an easy available and feasible
method for continuous visualisation during surgery. Intra-operative US reduces
the resection of healthy breast tissue and improves tumour-free resection
margins.
In the present study, the value of the use of US during the resection of
palpable tumours of the breast will be investigated. The objectives will be to
determine whether US-guided resection of palpable breast cancer allows sparing
of the breast tissue while preserving tumour-free resection margins with
improvements in cosmetic outcomes and quality of life.
Study objective
To reduce the extent of healthy breast tissue resection by US-guided surgery
for palpable tumours compared to traditional palpation-guided surgery, without
compromising oncological principles. To improve cosmetic outcomes and quality
of life by US-guided surgery or palpable tumours.
Study design
Prospective multicentre randomised controlled clinical trial.
Intervention
US-guided surgery (USS).
(Control: Traditional palpation-guided surgery (PGS)).
Study burden and risks
No injury / risk caused by USS is expected.
Boelelaan 1117
1081 HV Amsterdam
NL
Boelelaan 1117
1081 HV Amsterdam
NL
Listed location countries
Age
Inclusion criteria
Women age 25-75 yrs who are diagnosed with palpable early-stage (T1-2N0-1) primary breast cancer in the trial centres.
Breast cancer will be diagnosed with physical examination, mammography (2R) and US of the breast and axilla. The diagnosis of invasive (ductal or lobular) breast cancer will be established with image-guided core needle biopsy or cytological puncture.
All patients will be suitable for BCT according to national guidelines.
Participants will not have a history of prior mammary surgery in the affected breast, radiation therapy or neo-adjuvant therapy.
Participants will have ASA Classification I - III and will be well-informed having signed an informed consent form.
Exclusion criteria
Participants with a history of prior mamma surgery, radiation therapy or neo-adjuvant therapy.
Patients younger than 25 years, patients age above 75 years.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL31664.029.10 |