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Trial Title:
Impact of Systematic Shaving on Margins
NCT ID:
NCT05782686
Condition:
Margin, Tumor-Free
Breast Cancer
Surgery
Conditions: Official terms:
Breast Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Randomized clinical trial
Primary purpose:
Treatment
Masking:
Double (Participant, Investigator)
Masking description:
Randomization will be performed by another investigator outside the operating room after
lumpectomy.
Intervention:
Intervention type:
Procedure
Intervention name:
Margin shaving
Description:
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.
Arm group label:
No Shaving
Arm group label:
Shaving
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).
Criteria for eligibility:
Criteria:
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;
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Hospital de Bellvitge
Address:
City:
Hospitalet de Llobregat
Zip:
08907
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Amparo Garcia-Tejedor, MDPhD
Phone:
0034-932607695
Email:
agarciat@bellvitgehospital.cat
Start date:
October 7, 2020
Completion date:
October 16, 2025
Lead sponsor:
Agency:
Hospital Universitari de Bellvitge
Agency class:
Other
Source:
Hospital Universitari de Bellvitge
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05782686
