Breast Neoplasms
Conditions
Keywords
sentinel lymph node biopsy, frozen section, breast cancer, intraoperative pathology, axillary staging
Brief summary
This prospective randomized clinical study evaluates the role of intraoperative frozen section examination of sentinel lymph nodes in patients with breast cancer. The study aims to determine whether frozen section assessment during surgery improves intraoperative decision-making and affects surgical management when compared with standard final pathological evaluation performed after surgery.
Interventions
DIAGNOSTIC_TESTIntraoperative Frozen Section Examination of Sentinel Lymph Node
Sentinel lymph nodes are rapidly transported to pathology without formaldehyde fixation and are evaluated intraoperatively by frozen section.
DIAGNOSTIC_TESTRoutine Postoperative Histopathological Evaluation of Sentinel Lymph Node
Sentinel lymph nodes are processed after formaldehyde fixation and evaluated with routine histopathology after surgery.
Sponsors
Izmir City Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Masking description
No masking is applied. Surgeons and pathologists are aware of the intraoperative frozen section assessment.
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* Patients diagnosed with breast carcinoma * No prior neoadjuvant treatment
Exclusion criteria
* Inability to localize the sentinel lymph node preoperatively by lymphoscintigraphy or blue dye * Previous axillary surgery * Recurrent breast cancer * Patients who cannot receive radiotherapy * Prior neoadjuvant treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants randomized to the frozen section group and the routine histopathology group | From first participant enrollment until the target sample size is reached, up to 1 year | Count of participants randomized by sealed-envelope method to either intraoperative frozen section evaluation of sentinel lymph nodes or routine histopathological evaluation after formalin fixation. This outcome will be reported as the total number of randomized participants until the protocol-defined target sample size for between-group comparison is reached (planned total sample size: 142 participants). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of participants in the routine histopathology group who require axillary lymph node dissection | From surgery until final histopathological evaluation and multidisciplinary treatment decision, up to 30 days | Percentage of participants assigned to the routine histopathology group without intraoperative frozen section who require axillary lymph node dissection based on final histopathological evaluation and multidisciplinary treatment decision. |
Countries
Turkey (Türkiye)
Contacts
PRINCIPAL_INVESTIGATOROrhan Ureyen, Prof. / MD
Izmir City Hospital / General Surgery
Outcome results
None listed