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Omitting vs. Doing Intraoperative Frozen Section Biopsy for Margin Status in Breast Conserving Surgery
Sponsor: Samsung Medical Center
Summary
* Study phase: 3 * Indication: Breast cancer patients undergoing breast conserving surgery * Primary objectives: To determine the effect of selective omission of intraoperative margin evaluation via frozen section on margin positive rate Secondary objectives: To determine the effect of selective omission of intraoperative margin evaluation via frozen section on reoperation rate, local recurrence rate, operation time, resection volume, medical cost and patient quality-of life * Hypothesis: Omitting intraoperative margin evaluation via frozen section biopsy in selected breast cancer patients does not increase margin positive rate * Study design: Randomized controlled trial * Sample size: 1292 patients * Procedures: breast conserving surgery +/- margin frozen section biopsy (+/- additional resection)
Official title: A Randomized Controlled Trial for Doing vs. Omitting Intraoperative Frozen Section Biopsy For Resection MArgin Status in Selected Patients Undergoing Breast Conserving Surgery
Key Details
Gender
FEMALE
Age Range
19 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
1292
Start Date
2020-09-24
Completion Date
2026-06
Last Updated
2021-10-21
Healthy Volunteers
No
Conditions
Interventions
Omission of intraoperative frozen section biopsy for margin status
Omitting intraoperative frozen section biopsy for margin status in patients undergoing breast conserving surgery
Frozen section biopsy for margin status
Performing intraoperative frozen section biopsy for margin status in patients undergoing breast conserving surgery
Locations (2)
Ilsan Paik Hospital
Goyang-si, South Korea
Seoul St. Mary's Hospital
Seoul, South Korea