Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Frozen Section Group | Experimental | Participants undergo sentinel lymph node biopsy with intraoperative frozen section examination. Sentinel lymph nodes are identified using blue dye and a gamma probe, and intraoperative decision-making regarding additional axillary intervention is based on frozen section results. |
|
| Routine Histopathology Group | Active Comparator | Participants undergo sentinel lymph node biopsy without intraoperative frozen section. Sentinel lymph nodes are identified using blue dye and a gamma probe, then processed after formaldehyde fixation with routine histopathological evaluation. Further axillary treatment is decided according to final pathology and tumor board assessment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intraoperative Frozen Section Examination of Sentinel Lymph Node | Diagnostic Test | Sentinel lymph nodes are rapidly transported to pathology without formaldehyde fixation and are evaluated intraoperatively by frozen section. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants randomized to the frozen section group and the routine histopathology group | 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). | From first participant enrollment until the target sample size is reached, up to 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants in the routine histopathology group who require axillary lymph node dissection | 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. | From surgery until final histopathological evaluation and multidisciplinary treatment decision, up to 30 days |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Orhan Ureyen, Prof. / MD | Izmir City Hospital / General Surgery | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SBÜ İzmir Şehir Hastanesi | Izmir | İzmir | 35100 | Turkey (Türkiye) |
Not provided
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
No masking is applied. Surgeons and pathologists are aware of the intraoperative frozen section assessment.
Not provided
| Routine Postoperative Histopathological Evaluation of Sentinel Lymph Node | Diagnostic Test | Sentinel lymph nodes are processed after formaldehyde fixation and evaluated with routine histopathology after surgery. |
|
| D017437 |
| Skin and Connective Tissue Diseases |