A Randomized Trial Compared the Efficacy and Safety of Combined Use of Indocyanine Green Fluorescence and Methylene Blue Dye Versus Methylene Blue Dye alone for Sentinel Lymph Node Biopsy in Breast Cancer Patients

Conditions

None listed

Brief summary

Methylene blue is widely used in developing country for SLNB.The ICG is an innovative fluorescent tracer that could be visualized by near-infrared camera.This trial is designed to compare the efficacy and Safety of Combined Use of ICG Fluorescence and Methylene Blue Dye versus dye alone for SLNB in Breast Cancer Patients.

Wang C, Tong F, Cao Y, Liu P, Zhou B, Liu H, Cheng L, Liu M, Guo J, Xie F, Yang H, Wang S, Peng Y, Wang S.

2021-03-2417 citations

10.1007/s10549-021-06196-6

Comparison of sentinel lymph node biopsy guided by indocyanine green, blue dye, and their combination in breast cancer patients: a prospective cohort study.

Guo J, Yang H, Wang S, Cao Y, Liu M, Xie F, Liu P, Zhou B, Tong F, Cheng L, Liu H, Wang S.

2017-11-0292 citations

10.1186/s12957-017-1264-7

Interventions

The patients are randomly assigned to one of two groups, receiving combined use of ICG and methylene blue(Combination Group) or methylene blue alone as the lymphatic mapping tracer.Methylene blue will be injected periareolarly or peritumorally 8 minutes before the standard biopsy insicion.In the combination group,ICG would be injected 3 minutes before the surgery.In the combination group, sentinel lymph nodes are identified by ICG fluorescence using a near-infrared camera and blue stained lymph

The patients are randomly assigned to one of two groups, receiving combined use of ICG and methylene blue(Combination Group) or methylene blue alone as the lymphatic mapping tracer.Methylene blue will be injected periareolarly or peritumorally 8 minutes before the standard biopsy insicion.In the combination group,ICG would be injected 3 minutes before the surgery.In the combination group, sentinel lymph nodes are identified by ICG fluorescence using a near-infrared camera and blue stained lymph nodes found during this precedure will also be resected, while in blue dye alone group, sentinel lymph nodes are identified as blue nodes along the blue lymphatic vessel.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to 85 Years

Healthy volunteers

No

Inclusion criteria

1.Histologically diagnosed as invasive breast cancer (T1-T3) 2.Clinical negative axillary lymph node 3.No distant metastasis

Exclusion criteria

1.Histologically identified positive lymph node 2.Palpable positive lymph node 3.A positive history of anaphylaxis or iodine allergy 4.A history of axillary surgery

Outcome results