Trials / Completed
CompletedNCT03083314
Selective Axillary Lymph Node Dissection Vs Complete Axillary Dissection: A Randomised Clinical Trial to Assess the Prevention of Lymphedema in Breast Cancer Treatment
SELECTIVE AXILLARY LYMPH NODE DISSECTION VS COMPLETE AXILLARY DISSECTION: A RANDOMISED CLINICAL TRIAL TO ASSESS THE PREVENTION OF LYMPHEDEMA IN BREAST CANCER TREATMENT
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 130 (actual)
- Sponsor
- Fondazione IRCCS Istituto Nazionale dei Tumori, Milano · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a pilot study at the National Cancer Institute (INT) of Milan evaluated the feasibility of selective axillary dissection (SAD) which preserved the lymphatic drainage of the arm. Lymph nodes draining the arm are identified following radiotracer injection and lymphoscintigraphy, a technique called axillary reverse mapping (ARM). SAD was found feasible in 75% of patients. Furthermore only 9% had BCRL after SAD compared to 33% after axillary lymph node dissection (ALND).
Detailed description
To evaluate the efficacy, safety and cost reduction of SAD compared to standard ALND, we propose a prospective 2-arm randomised trial. The control arm consists of patients randomized to ALND, the study arm consists of patients randomized to SAD.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | SELECTIVE AXILLARY LYMPH NODE DISSECTION (SAD) | |
| PROCEDURE | COMPLETE AXILLARY DISSECTION (ALND) |
Timeline
- Start date
- 2014-06-12
- Primary completion
- 2018-11-15
- Completion
- 2020-12-04
- First posted
- 2017-03-20
- Last updated
- 2021-04-09
Locations
1 site across 1 country: Italy
Source: ClinicalTrials.gov record NCT03083314. Inclusion in this directory is not an endorsement.