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Delayed Selective Sentinel Node Biopsy for Patients Undergoing Mastectomy for DCIS

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ClinicalTrials.gov Identifier: NCT05912569
Recruitment Status : Recruiting
First Posted : June 22, 2023
Last Update Posted : April 5, 2024
Sponsor:
Information provided by (Responsible Party):
Hyeong-Gon Moon, Seoul National University Hospital

Study Description
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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
DCIS Procedure: Delay sentinel node biopsy Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 84 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Feasibility Study on Delayed Selective Sentinel Node Biopsy for Patients Undergoing Mastectomy for Ductal Carcinoma in Situ
Actual Study Start Date : June 13, 2023
Estimated Primary Completion Date : April 28, 2025
Estimated Study Completion Date : April 28, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy Mastectomy

Arms and Interventions
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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
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Primary Outcome Measures :
  1. success rate [ 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.


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients aged 20 to 75 years old.
  • Patients diagnosed with DCIS through histological examination.
  • Patients undergoing mastectomy

Exclusion Criteria:

  • 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05912569


Locations
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Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 03080
Contact: Hyeong-Gon Moon, MD    02-2072-2634    moonhgsurgi@gmail.com   
Contact: Eunhye Kang, MD    02-2072-2817    rkd4327@naver.com   
Sponsors and Collaborators
Seoul National University Hospital
More Information
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Responsible Party: Hyeong-Gon Moon, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT05912569    
Other Study ID Numbers: 2212-088-1386
First Posted: June 22, 2023    Key Record Dates
Last Update Posted: April 5, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No