Seoul National University Hospital
Seoul, 03080, South Korea
Location status: Recruiting
Location contact
Eunhye Kang, MD
CONTACT
Hyeong-Gon Moon, MD
CONTACT
NCT Number: NCT05912569
In the case of a patient undergoing total mastectomy for intraductal carcinoma (DCIS), 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.
addendum) The previously documented Breast-Conserving Surgery has been corrected to reflect the accurate procedure of Total Mastectomy.
Interested in participating?
Request Info20 year–75 year
All sexes
Interventional
Not applicable
Seoul, 03080, South Korea
Location status: Recruiting
Eunhye Kang, MD
CONTACT
Hyeong-Gon Moon, MD
CONTACT
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.
total mastectomy 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 (Maxon 3-0, a slow monofilament absorbable suture).
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.
addendum)
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 involves identifying the marked areas using clips or sutures and detecting sentinel lymph nodes for biopsy.
The number of removed clips/sutures and the number of sentinel lymph nodes identified are documented for record keeping.
addendum) Axillary X-ray and Sentinel Node Mapping Axillary x-ray and the use of blue dye or radioisotope injection for sentinel lymph node mapping are not mandatory and may be utilized at the physician's discretion.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: 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.
Seoul National University Hospital
Other
Feasibility Study on Delayed Selective Sentinel Node Biopsy for Patients Undergoing Mastectomy for Ductal Carcinoma in Situ
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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