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Delayed Selective Sentinel Node Biopsy for Patients Undergoing Mastectomy for DCIS

DCIS Clinical Trial

Official title:
Feasibility Study on Delayed Selective Sentinel Node Biopsy for Patients Undergoing Mastectomy for Ductal Carcinoma in Situ

Clinical Trial Summary

In the case of a patient undergoing breast-conserving surgery for intraductal carcinoma, the sentinel lymph node is not excised during the primary surgery but only marked for identification. If the final histological examination confirms invasive cancer, delayed surgery is performed to remove the sentinel lymph node that was marked during the initial surgery. primary endpoint : The success rate of identifying the sentinel lymph node that was marked during the primary surgery in cases where the final histological examination confirms invasive cancer is evaluated.

Clinical Trial Description

Primary surgery: Patients diagnosed with intraductal carcinoma through histological examination and scheduled for axillary lymph node dissection are included. Prior to the surgery, blue dye and/or radioisotope injection are used to identify the sentinel lymph node, similar to the current practice. Breast-conserving surgery is performed. After identifying the sentinel lymph node in the axillary region, its location is marked using a titanium clip (size 2-4mm) or sutures. The number of marked sentinel lymph nodes is recorded for documentation. Confirmation of pathological examination results: If the final surgical specimen confirms invasive carcinoma (size > 1mm) through pathological examination, sentinel lymph node surgery is performed. Secondary surgery: Prior to the surgery, an axillary view x-ray is taken to verify the location and number of the clips. Blue dye and/or radioisotope injection is administered near the axillary incision site. Accessing the axillary region, the marked areas using clips or sutures and the detection methods of blue dye/radioisotope are used to identify the sentinel lymph node for sentinel lymph node biopsy. The number of removed clips/sutures and the number of sentinel lymph nodes identified are documented for record keeping. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05912569
Study type Interventional
Source Seoul National University Hospital
Contact
Status Recruiting
Phase N/A
Start date June 13, 2023
Completion date April 28, 2025
View Details
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