Breast Cancer Related LymphedemaDEPARTNCT04446494
Identification and Preservation of Arm Lymphatics
A study testing Identification and preservation of arm lymphatics (DEPART) in people with Breast Cancer Related Lymphedema, run by Wuhan University at 1 site in China.
Trial summary
Controversy in axillary reverse mapping in axillary lymph node dissection (ALND) possibly results from incomplete recognition of the arm lymphatic system (ALS) and its compromise to oncological safety. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Breast Cancer Related Lymphedema
- What is being tested?
- Identification and preservation of arm lymphatics (DEPART)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- 1 siteChina
- Study dates
- 20 Jun 2020to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18 years or older with T1-3 invasive breast cancer;
- Clinically node-positive breast cancer, defined as positive on preoperative axillary palpation, ultrasound examination, and computed tomography scan with contrast;
- Patients who underwent mastectomy with a positive sentinel lymph node (SLN);
- Patients who underwent breast-conserving surgery containing more than two positive SLNs.
Who cannot join
- Neoadjuvant chemotherapy;
- Previous history of breast cancer.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, 430071
Qianqian Yuan, MD., +8613026322297, Yuanqq11@whu.edu.cn
About this study
Official title: Identification and Preservation of Arm Lymphatics (DEPART) in Axillary Dissection for Breast Cancer to Reduce Arm Lymphedema Events: A Multicenter Randomized Clinical Trial
Controversy in axillary reverse mapping in axillary lymph node dissection (ALND) possibly results from incomplete recognition of the arm lymphatic system (ALS) and its compromise to oncological safety. The iDEntification and Preservation of ARm lymphaTics (DEPART) technique facilitates complete identification of ALS; therefore, its use may decrease the occurrence of arm lymphedema. This study aimed to examine the arm lymphedema rate, locoregional recurrence, and feasibility to perform DEPART in ALND.
In the study group, indocyanine green and methylene blue (MB) were utilized to identify arm sentinel nodes, and 0.1 ml MB was injected into the arm sentinel nodes to reveal the subsequent-echelon nodes and lymphatics. Gross arm lymph nodes were examined by intraoperative partial frozen section and were removed if positive. Arm lymphedema, local recurrence, regional recurrence, and distant metastasis were recorded at different follow-up examinations.
- Conditions
- Breast Cancer Related Lymphedema
- Being tested
- Identification and preservation of arm lymphatics (DEPART)
- Keywords
- breast cancer, axillary lymph node dissection, lymphedema
- Medical subject headings
- Breast Cancer Lymphedema, Breast Neoplasms, Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Identification and preservation of arm lymphatics (DEPART)Procedure or surgery
Indocyanine green was utilized to identify arm sentinel nodes, and 0.1 ml MB was injected into the arm sentinel nodes to reveal the subsequent-echelon nodes and lymphatics. Gross arm lymph nodes were examined by intraoperative partial frozen section and were removed if positive.
| Study group | Role | What they receive |
|---|---|---|
| Axillary dissection with DEPART technique | Experimental | In the experimental group, 1 ml (2.5 mg) indocyanine green (ICG) and methylene blue (MB) was intradermally injected into the internal bicipital sulcus of ipsilateral arm. During axillary dissection, the identified arm sentinel nodes were carefully injected with 0.1 ml methylene blue (MB) using a 1-cc syringe with a 32-gauge needle. MB could then flow from the nodes along several lymphatic channels toward the infraclavicular nodes. Subsequent-echelon nodes and lymphatics were identified. Sentinel lymph nodes (SLNs) were removed after the identification of the arm sentinel nodes and the procedure of MB injection. When patients harbored positive SLNs, axillary lymph node dissection (ALND) was performed subsequently. All discernible arm lymphatics and lymph nodes were preserved, except that gross arm lymph nodes (major axis larger than 10 mm or node firm on palpation) were sent for immediate partial frozen section (pFS) to determine their resection during ALND. Receives: Procedure: Identification and preservation of arm lymphatics (DEPART) |
| Standard axillary dissection | No intervention | In the control group (no intervention), ALND was performed with complete resection of at least Berg's levels I and II. Resection of level III was performed only in cases with gross disease in level II and/or III |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of arm lymphedema
A difference in volume between the arms < 10% was defined as lymphedema.
Measured: Up to 2 years
Secondary outcomes (2)
Rate of locoregional recurrence
Locoregional recurrence included local recurrence and regional recurrence. Local recurrence was defined as chest wall recurrence of breast cancer, and regional recurrence was defined as the axilla recurrence of breast cancer.
Measured: 5-year estimate reported after a median follow-up of 60 months
Rate of distant metastasis
Cancer cells from breast metastasized to other organs.
Measured: 5-year estimate reported after a median follow-up of 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2020
- Study start20 Jun 2020
- Primary completion30 Sep 2021 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast Cancer Related LymphedemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wuhan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gaosong Wu, Ph D, MD, Wuhan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04446494
- Sponsor's protocol ID
- ZLYNXM202014
- Acronym
- DEPART
- Status last verified
- Dec 2020
- First submitted
- 21 Jun 2020
- Last updated
- 10 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yuan Q, Wu G, Xiao SY, Hou J, Ren Y, Wang H, Wang K, Zhang D. Identification and Preservation of Arm Lymphatic System in Axillary Dissection for Breast Cancer to Reduce Arm Lymphedema Events: A Randomized Clinical Trial. Ann Surg Oncol. 2019 Oct;26(11):3446-3454. doi: 10.1245/s10434-019-07569-4. Epub 2019 Jun 25.
PubMed 31240591
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification and Preservation of Arm Lymphatics (DEPART) in Axillary Dissection for Breast Cancer to Reduce Arm Lymphedema Events: A Multicenter Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04446494
- Acronym / sponsor ID
- DEPART / ZLYNXM202014
- Conditions
- Breast Cancer Related Lymphedema
- Keywords
- breast cancer, axillary lymph node dissection, lymphedema
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Wuhan UniversityUniversity, hospital or other
- Study start
- 20 Jun 2020 (actual)
- Primary completion
- 30 Sep 2021 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 25 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Controversy in axillary reverse mapping in axillary lymph node dissection (ALND) possibly results from incomplete recognition of the arm lymphatic system (ALS) and its compromise to oncological safety. The iDEntification and Preservation of ARm lymphaTics (DEPART) technique facilitates complete identification of ALS; therefore, its use may decrease the occurrence of arm lymphedema. This study aimed to examine the arm lymphedema rate, locoregional recurrence, and feasibility to perform DEPART in ALND.
In the study group, indocyanine green and methylene blue (MB) were utilized to identify arm sentinel nodes, and 0.1 ml MB was injected into the arm sentinel nodes to reveal the subsequent-echelon nodes and lymphatics. Gross arm lymph nodes were examined by intraoperative partial frozen section and were removed if positive. Arm lymphedema, local recurrence, regional recurrence, and distant metastasis were recorded at different follow-up examinations.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Axillary dissection with DEPART technique | Experimental | Procedure: Identification and preservation of arm lymphatics (DEPART)In the experimental group, 1 ml (2.5 mg) indocyanine green (ICG) and methylene blue (MB) was intradermally injected into the internal bicipital sulcus of ipsilateral arm. During axillary dissection, the identified arm sentinel nodes were carefully injected with 0.1 ml methylene blue (MB) using a 1-cc syringe with a 32-gauge needle. MB could then flow from the nodes along several lymphatic channels toward the infraclavicular nodes. Subsequent-echelon nodes and lymphatics were identified. Sentinel lymph nodes (SLNs) were removed after the identification of the arm sentinel nodes and the procedure of MB injection. When patients harbored positive SLNs, axillary lymph node dissection (ALND) was performed subsequently. All discernible arm lymphatics and lymph nodes were preserved, except that gross arm lymph nodes (major axis larger than 10 mm or node firm on palpation) were sent for immediate partial frozen section (pFS) to determine their resection during ALND. |
| Standard axillary dissection | No intervention | –In the control group (no intervention), ALND was performed with complete resection of at least Berg's levels I and II. Resection of level III was performed only in cases with gross disease in level II and/or III |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients aged 18 years or older with T1-3 invasive breast cancer;
- Clinically node-positive breast cancer, defined as positive on preoperative axillary palpation, ultrasound examination, and computed tomography scan with contrast;
- Patients who underwent mastectomy with a positive sentinel lymph node (SLN);
- Patients who underwent breast-conserving surgery containing more than two positive SLNs.
Key exclusion criteria (2 listed)
- Neoadjuvant chemotherapy;
- Previous history of breast cancer.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Identification and preservation of arm lymphatics (DEPART)Indocyanine green was utilized to identify arm sentinel nodes, and 0.1 ml MB was injected into the arm sentinel nodes to reveal the subsequent-echelon nodes and lymphatics. Gross arm lymph nodes were examined by intraoperative partial frozen section and were removed if positive. | Procedure or surgery | Axillary dissection with DEPART technique |
Primary outcome
Rate of arm lymphedema
Time frame: Up to 2 years
A difference in volume between the arms < 10% was defined as lymphedema.
2 secondary outcomes
Rate of locoregional recurrence
Time frame: 5-year estimate reported after a median follow-up of 60 months
Rate of distant metastasis
Time frame: 5-year estimate reported after a median follow-up of 60 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2020.
- Results publication: PubMed 31240591Yuan Q, Wu G, Xiao SY, Hou J, Ren Y, Wang H, Wang K, Zhang D. Identification and Preservation of Arm Lymphatic System in Axillary Dissection for Breast Cancer to Reduce Arm Lymphedema Events: A Randomized Clinical Trial. Ann Surg Oncol. 2019 Oct;26(11):3446-3454. doi: 10.1245/s10434-019-07569-4. Epub 2019 Jun 25.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Identification and preservation of arm lymphatics (DEPART) in people with Breast Cancer Related Lymphedema, run by Wuhan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Qianqian Yuan, MD. (+8613026322297, Yuanqq11@whu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of arm lymphedema (time frame: Up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04446494, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2020.