Delayed Selective Sentinel Node Biopsy for Patients Undergoing Mastectomy for DCIS

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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DCIS

Intervention / Treatment
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* Procedure: Delay sentinel node biopsy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: i) Patients aged 20 to 75 years old. ii) Patients diagnosed with intraductal carcinoma through histological examination. iii) Patients undergoing breast-conserving surgery. Exclusion Criteria: i) In cases where the histopathological findings of the tissue examination indicate suspicious invasive lesions. ii) In cases where imaging tests or physical examinations suggest possible lymph node metastasis. iii) In patients who have previously undergone axillary lymph node surgery on the same side as the current procedure. iv) Pregnant patients.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Delay sentinel node biopsy<br>sinlge arm | Procedure: Delay sentinel node biopsy<br>* 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. I<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| success rate | 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. | 2 weeks later |