Breast Cancer, Margin, Tumor-Free, Surgery
Conditions
Brief summary
The objective of this clinical trial is to demonstrate the reduction of positive margins in the definitive pathology of patients undergoing breast-conserving surgery with the systematic shaving technique compared to conventional surgery, and the reduction of second interventions for margin enlargement.
Detailed description
Patients with breast cancer who undergo breast-conserving surgery are randomized in the operating room after lumpectomy into 2 groups of 117 patients each: shaving/no-shaving (standard surgery).
Interventions
PROCEDUREMargin shaving
In both cohorts, an intraoperative study of the margins will be carried out, and enlargement of those margins that are affected will be carried out as indicated by the pathologist. Subsequently, shaving is performed in case of being randomized to the study group or surgery is completed in the control group.
Sponsors
Hospital Universitari de Bellvitge
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Randomization will be performed by another investigator outside the operating room after lumpectomy.
Intervention model description
Randomized clinical trial
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Breast-conserving surgery. 2. Imaging diagnosis as the only breast tumor focus according to mammography, breast ultrasound and/or nuclear magnetic resonance; 3. Pathological diagnosis of carcinoma in situ or infiltrating 4. Oncoplastic without associated flaps;
Exclusion criteria
1. Male patients; 2. Patients with a history of ipsilateral breast cancer. 3. Oncoplastic that includes flaps 4. Multifocality or multicentricity; 5. Pregnant or lactating patient; 6. Stage IV patients; 7. Patients eligible for mastectomy;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Margin involvement | 3 weeks after each surgery | To compare the number of cases with affected margins in the definitive pathological anatomy, of the cases with intraoperative systematic shaving versus the group of no shaving |
| Re-interventions | 3 weeks after each surgery | Demonstrate the reduction of second surgeries to widen affected margins in breast conserving surgery with the shaving technique |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Shaving versus intraoperative pathological study | 3 weeks after each surgery | Assess the possibility of replacing the intraoperative study of the margins with systematic shaving |
Countries
Spain
Contacts
CONTACTamparo garcia-tejedor, MDPhD
PRINCIPAL_INVESTIGATORAmparo Garcia Tejedor, MDPhD
Hospital de Bellvitge. Instituto de Investigación Biomédica de Bellvitge (IDIBELL)
Outcome results
None listed