Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05676866 |
| Other study ID # |
Targeted axillary dissection |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
Phase 4
|
| First received |
|
| Last updated |
|
| Start date |
December 1, 2023 |
| Est. completion date |
August 1, 2025 |
Study information
| Verified date |
January 2023 |
| Source |
Assiut University |
| Contact |
Omar Abd. Mahmoud, Resident doc |
| Phone |
01098386293 |
| Email |
omarico877[@]gmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
evaluation of targeted axillary lymph node dissection in node positive breast cancer patients
post neo adjuvant therapy
Description:
Targeted axillary dissection (TAD) is a novel technique in the field of surgical oncology.
During TAD, patients with node-positive breast cancer who clinically responded to neoadjuvant
chemotherapy undergo resection of a previously proven metastatic node together with sentinel
lymph node dissection (SLND).
Compared to sentinel lymph node dissection (SLND), axillary lymph node dissection [ALND] is
associated with increased morbidity, higher rates of lymphedema, paraesthesia, sensory loss
in the arm, and impairment in shoulder function. Patients undergoing SLND have fewer
infections and a better quality of life, so axillary dissection has been largely replaced by
SLND in early-stage breast cancer.
Targeted axillary dissection (TAD) is an innovative surgical procedure that emerged in an
attempt to further decrease the false negative results of SLND.
Breast cancer patients suitable for neoadjuvant systemic therapy [NAST] with node-positive
disease (N1,N2) were assessed by the multi-disciplinary team and if potentially eligible for
TAD, a metallic marker[clip] is inserted in the suspicious node prior to neoadjuvant therapy.
The procedure is performed together with SLND using a single-tracer technique. Towards the
end of NAST, a progress ultrasound and mammogram are performed to assess the breast and
axillary response, Clip position within node is confirmed.
A standard surgical approach for sentinel lymph node dissection [SLND] is used for TAD,
Patent blue dye is administered intraoperatively. dissection down to the localized node is
performed. node contained the clip is subsequently sent for histology. Any residual sentinel
nodes or palpable abnormal nodes are excised and examined separately.
