NCT03737266CompletedNot Applicable
Sonographically Assisted Versus Conventionally Breast Surgery in Breast Cancer Patients With an Indication for Breast Conserving Surgery After Neoadjuvant Chemotherapy
University Hospital Tuebingen2 sites in 1 country137 target enrollmentStarted: October 1, 2018Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 137
- Locations
- 2
- Primary Endpoint
- R0 resection rate
Study Overview
Brief Summary
Aim of the study is to investigate whether intra-surgical visualisation of malignoma reduces the resection rate in the case of R1 resection compared to the procedure without sonographic visualisation
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •18 to 80 years
- •Presurgical validated breast cancer
- •Unifocal to multifocal findings
- •Palpable and/o non-palpable findings
- •Neoadjuvant chemotherapy
- •Indication for breast conserving therapy
- •General operation ability and anesthesia ability
- •Consent to conventional breast conserving breast surgery with wire marking
- •Ability and will to follow the study conditions
- •Written declaration of consent after clarification
Exclusion Criteria
- •Sonographically not clearly delineate resection areal
- •Exclusion criteria for breast conserving therapy
- •Simultaneous participation in other interventional trials that interfere with this study at the investigator's discretion
Outcomes
Primary Outcomes
R0 resection rate
Time Frame: 3 years
proportion of surgical procedures for cancer in which the surgeon is able to completely remove all detectable tumor tissue with negative margins, indicating that no cancer cells remain in the surgical site
Secondary Outcomes
- Weight of primary resedate(3 years)
- Time for cut and sew(During surgery)
Investigators
Study Sites (2)
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