Delayed Selective Sentinel Node Biopsy for Patients Undergoing Mastectomy for DCIS

DCIS Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05912569
• Other study ID #: 2212-088-1386
• Status: Recruiting
• Phase: N/A
• Start date: June 13, 2023
• Est. completion date: April 28, 2025

Study information

• Verified date: April 2024
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 84
• Est. completion date: April 28, 2025
• Est. primary completion date: April 28, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• DCIS

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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