Delayed Selective Sentinel Node Biopsy for Patients Undergoing Mastectomy for DCIS
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed 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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Delay sentinel node biopsy sinlge arm |
Procedure: Delay sentinel node biopsy
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
|
Outcome Measures
Primary Outcome Measures
- success rate [2 weeks later]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients aged 20 to 75 years old. ii) Patients diagnosed with intraductal carcinoma through histological examination.
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Patients undergoing breast-conserving surgery.
Exclusion Criteria:
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In cases where the histopathological findings of the tissue examination indicate suspicious invasive lesions.
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In cases where imaging tests or physical examinations suggest possible lymph node metastasis.
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In patients who have previously undergone axillary lymph node surgery on the same side as the current procedure.
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Pregnant patients.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Seoul National University Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2212-088-1386