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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
142
Sentinel lymph nodes are rapidly transported to pathology without formaldehyde fixation and are evaluated intraoperatively by frozen section.
Sentinel lymph nodes are processed after formaldehyde fixation and evaluated with routine histopathology after surgery.
SBÜ İzmir Şehir Hastanesi
Izmir, İzmir, Turkey (Türkiye)
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).
Time frame: From first participant enrollment until the target sample size is reached, up to 1 year
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.
Time frame: From surgery until final histopathological evaluation and multidisciplinary treatment decision, up to 30 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.