Frozen Section Examination of Sentinel Lymph Nodes in Breast Cancer

Condition(s) studied

Investigational drug(s) / intervention(s)

Intraoperative 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.

Routine Postoperative Histopathological Evaluation of Sentinel Lymph Node: Sentinel lymph nodes are processed after formaldehyde fixation and evaluated with routine histopathology after surgery.

Study 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.

Eligibility

Primary outcome measure(s)

• 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).

Trial sites (1)

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