Identification and Preservation of Arm Lymphatics

NCT04446494 | Unknown DMC

• 1 other identifier: ZLYNXM202014
• Study Type: interventional
• Target: 1,200
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

breast cancer; axillary lymph node dissection; lymphedema

Outcome Measures

Primary Outcomes (1)

• Rate of arm lymphedema

  A difference in volume between the arms \< 10% was defined as lymphedema.

  Up to 2 years

Secondary Outcomes (2)

• Rate of locoregional recurrence

  5-year estimate reported after a median follow-up of 60 months

• Rate of distant metastasis

  5-year estimate reported after a median follow-up of 60 months

Study Arms (2)

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.

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

Interventions

Identification and preservation of arm lymphatics (DEPART) PROCEDURE

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.

Axillary dissection with DEPART technique

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Neoadjuvant chemotherapy;
• Previous history of breast cancer.

Sponsors & Collaborators

• Wuhan University: lead

Study Sites (1)

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, 430071, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 31240591 RESULT

MeSH Terms

Conditions

Breast Cancer Lymphedema; Breast Neoplasms; Lymphedema

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Qianqian Yuan, MD.

CONTACT

+8613026322297; Yuanqq11@whu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair, Department of Thyroid and Breast Surgery, Zhongnan Hospital of Wuhan University

Study Record Dates

• First Submitted: June 21, 2020
• First Posted: June 25, 2020
• Study Start: June 20, 2020
• Primary Completion: September 30, 2021
• Study Completion: September 30, 2025
• Last Updated: December 10, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)