Comparison of Conventional With Sonography Assisted Breast Surgery After Neoadjuvant Chemotherapy

University Hospital Tuebingen

Status: Completed

Conditions: Breast Cancer Surgery

Treatments: Procedure: Conventional breast surgery; Procedure: Sonographically assisted breast surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT03737266

Seno_Ex_MAC 003

Details and patient eligibility

About

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

Enrollment: 137 patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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137 participants in 2 patient groups

Sonographically assisted breast surgery

Experimental group

Description:

Sonography assisted breast surgery

Treatment:

Procedure: Conventional breast surgery

Procedure: Sonographically assisted breast surgery

Conventional breast surgery

Active Comparator group

Description:

Conventional breast surgery

Treatment:

Procedure: Conventional breast surgery

Procedure: Sonographically assisted breast surgery