Ignite Creation Date:
2025-12-24 @ 11:04 PM
Ignite Modification Date:
2025-12-25 @ 8:35 PM
Study NCT ID:
NCT05912569
Status:
RECRUITING
Last Update Posted:
2025-01-31
First Post:
2023-06-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Delayed Selective Sentinel Node Biopsy for Patients Undergoing Mastectomy for DCIS
Sponsor:
Seoul National University Hospital
Organization:
Study Overview
Official Title:
Feasibility Study on Delayed Selective Sentinel Node Biopsy for Patients Undergoing Mastectomy for Ductal Carcinoma in Situ
Status:
RECRUITING
Status Verified Date:
2025-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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.
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.
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)
1. Suture Specification The surgical procedure will utilize Maxon 3-0, a slow monofilament absorbable suture for optimal tissue approximation and healing.
2. Management of Microinvasive Cancer For cases where the tumor size is 1 mm or smaller (microinvasive cancer), the decision to proceed with reoperation will be made at the discretion of the treating physician based on clinical judgment.
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.
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)
1. Suture Specification The surgical procedure will utilize Maxon 3-0, a slow monofilament absorbable suture for optimal tissue approximation and healing.
2. Management of Microinvasive Cancer For cases where the tumor size is 1 mm or smaller (microinvasive cancer), the decision to proceed with reoperation will be made at the discretion of the treating physician based on clinical judgment.
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.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: