Delayed Selective Sentinel Node Biopsy for Patients Undergoing Mastectomy for DCIS
ConditionDCIS
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-75
SponsorSeoul National University Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients aged 20 to 75 years old.
Patients diagnosed with DCIS through histological examination.
Patients undergoing mastectomy
Disqualifiers
In cases where the histopathological findings of the tissue examination indicate suspicious invasive lesions.
In cases where imaging tests or physical examinations suggest possible lymph node metastasis.
In patients who have previously undergone axillary lymph node surgery on the same side as the current procedure.
Pregnant patients.
Trial design
Design model
Single group
Treatments tested in this trial
Delay sentinel node biopsy
Procedure/SurgeryIn 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
Treatment groups
84 Participants
are divided into 1 treatment groupGroup A: Delay sentinel node biopsyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
2 weeks laterSponsors and contacts
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Source ClinicalTrials.gov