NCT03941756

Lymphovenous Bypass Procedure Before Underarm Lymph Node Surgery in Preventing Lymphedema in Patients With Inflammatory or Locally Advanced Non-inflammatory Breast Cancer or Melanoma

Prophylactic Lymphovenous Bypass Procedure Following Axillary Lymphadenectomy: A Prospective Observational Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 252 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This pilot trial studies whether a procedure called lymphovenous bypass would prevent lymphedema (arm swelling) in patients with inflammatory breast cancer or non-inflammatory breast cancer that has spread to nearby tissues or lymph nodes or melanoma. The lymphovenous bypass procedure creates a path for lymphatic fluid to flow away from the arms. It is usually done after a diagnosis of lymphedema. In this study, giving lymphovenous bypass before underarm lymph node surgery may help prevent lymphedema from forming.

Detailed description

PRIMARY OBJECTIVES: I. To evaluate the protective benefit to performing standard of care lymphovenous bypass (LVB) surgery at the time of standard of care axillary lymph node dissection (ALND) for patients that are high risk for developing breast-cancer related lymphedema (LE) of the upper extremity. SECONDARY OBJECTIVES: I. Compare the medical outcomes for patients that received the LVB surgery with those receiving standard surgery in whom the intervention could not be performed. OUTLINE: Patients are randomized to 1 of 2 groups. GROUP I: Patients receive indocyanine green intravenously (IV) and undergo lymphangiography, then undergo LVB at the time of ALND. GROUP II: Patients do not receive indocyanine green, undergo lymphangiography, nor undergo LVB at the time of ALND. After completion of study, patients are followed up at 2 weeks, and then at 6, 12, and 18 months.

Conditions

• Anatomic Stage III Breast Cancer AJCC v8
• Breast Inflammatory Carcinoma
• Locally Advanced Breast Carcinoma
• Melanoma

Interventions

Type	Name	Description
DRUG	Indocyanine Green	Given IV
PROCEDURE	Lymphangiography	Undergo lymphangiography
PROCEDURE	Lymphovenous Bypass	Undergo LVB

Timeline

• Start date: 2018-08-14
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2019-05-08
• Last updated: 2025-11-10

Locations

1 site across 1 country: United States