Evaluation of Targeted Axillary Lymph Node Dissection in Node Positive Breast Cancer Patients Post Neo Adjuvant Therapy
NCT ID: NCT05676866
Last Updated: 2023-01-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
30 participants
INTERVENTIONAL
2023-12-01
2025-08-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Breast cancer patients with positive axillary nodes
Female with invasive breast cancer with axillary metastasis , who recieve neo adjuvant therapy with complete axillary response
Targeted axillary lymph node dissection
Targeted axillary lymph node dissection is done by marking suspicious node with metallic clip prior to neo adjuvant therapy ,then neo adjuvant therapy is given and after complete axillary response (proved by radiological and clinical examination) , targeted axillary lymph node dissection of clipped node is done along with sentinel lymph node dissection
Interventions
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Targeted axillary lymph node dissection
Targeted axillary lymph node dissection is done by marking suspicious node with metallic clip prior to neo adjuvant therapy ,then neo adjuvant therapy is given and after complete axillary response (proved by radiological and clinical examination) , targeted axillary lymph node dissection of clipped node is done along with sentinel lymph node dissection
Eligibility Criteria
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Inclusion Criteria
2. complete axillary response to neoadjuvant therapy by clinical examination and imaging
Exclusion Criteria
15 Years
70 Years
FEMALE
Yes
Sponsors
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Assiut University
OTHER
Responsible Party
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Omar Abdelnasser Mahmoud Ali
Resident doctor /Omar abdelnasser Mahmoud
Central Contacts
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Related Links
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The Feasibility and Accuracy of Sentinel Lymph Node Biopsy in Initially Clinically Node-Negative Breast Cancer after Neoadjuvant Chemotherapy: A Systematic Review and Meta-Analysis
Targeted Axillary Dissection in Node-Positive Breast Cancer: A Retrospective Study and Cost Analysis
Improved Model for Predicting Axillary Response to Neoadjuvant Chemotherapy in Patients with Clinically Node-Positive Breast Cancer
Feasibility and Accuracy of Sentinel Lymph Node Biopsy in Clinically Node-Positive Breast Cancer after Neoadjuvant Chemotherapy: A Meta-Analysis
Comprehensive Axillary Evaluation in Neoadjuvant Chemotherapy Patients With Ultrasonography and Sentinel Lymph Node Biopsy
Other Identifiers
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Targeted axillary dissection
Identifier Type: -
Identifier Source: org_study_id
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