Comparison of Conventional With Sonography Assisted Breast Surgery After Neoadjuvant Chemotherapy

Not Applicable

Completed

• Conditions: Breast Cancer Surgery
• Interventions: Procedure: Sonographically assisted breast surgery; Procedure: Conventional breast surgery

• Registration Number: NCT03737266
• Lead Sponsor: University Hospital Tuebingen

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

Detailed Description

Not available

Study Timeline

• Study Start: 2018-10-01
• Study First Submitted: 2018-10-16
• Study First Submitted QC: 2018-11-08
• Study First Posted: 2018-11-09
• Primary Completion: 2023-01-01
• Study Completion: 2023-01-01
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-13
• Last Update Posted: 2024-02-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 137

Inclusion Criteria

• 18 to 80 years
• Female
• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sonographically assisted breast surgery	Conventional breast surgery	Sonography assisted breast surgery
Conventional breast surgery	Conventional breast surgery	Conventional breast surgery
Sonographically assisted breast surgery	Sonographically assisted breast surgery	Sonography assisted breast surgery
Conventional breast surgery	Sonographically assisted breast surgery	Conventional breast surgery

Primary Outcome Measures

Name	Time	Method
R0 resection rate	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 Outcome Measures

Name	Time	Method
Weight of primary resedate	3 years	weight of the tumor tissue removed during surgery for cancer
Time for cut and sew	During surgery	duration of the surgical procedure from the initial incision to the completion of the closure of the incision site

Trial Locations

Locations (1)

Department for Women's Health; 🇩🇪 Tübingen, BW, Germany