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Clinical Trials/NCT03737266
NCT03737266
Completed
Not Applicable

Sonographically Assisted Versus Conventionally Breast Surgery in Breast Cancer Patients With an Indication for Breast Conserving Surgery After Neoadjuvant Chemotherapy

University Hospital Tuebingen1 site in 1 country137 target enrollmentOctober 1, 2018
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ConditionsBreast Cancer Surgery

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Breast Cancer Surgery
Sponsor
University Hospital Tuebingen
Enrollment
137
Locations
1
Primary Endpoint
R0 resection rate
Status
Completed
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

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

Registry
clinicaltrials.gov
Start Date
October 1, 2018
End Date
January 1, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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)

Study Sites (1)

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