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Application of fluorescent endoscopic indocyanine green combined with blue dye in sentinel lymph node biopsy of early breast cancer

Application of fluorescent endoscopic indocyanine green combined with blue dye in sentinel lymph node biopsy of early breast cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2200065770
Enrollment
Unknown
Registered
2022-11-15
Start date
2022-11-15
Completion date
Unknown
Last updated
2023-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

breast cancer

Interventions

indocyanine green group:Indocyanine green was developed and traced under fluorescence cavity microscope.
blue dye group:The tracer was developed by methylene blue under fluorescence cavity.
indocyanine green combined with blue dye group:Indocyanine green and methylene blue were developed under fluorescence cavity.

Sponsors

Zhujiang Hospital of Southern Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Patients with preoperative clinical staging of cT1-T3, N0, M0. 2. Clinical examination of axillary lymph nodes was negative. 3. Aged >= 18 years.

Exclusion criteria

Exclusion criteria: 1. Distant metastasis of cancer. 2. With inflammatory breast cancer. 3. Suspicious axillary lymph node metastasis was found by clinical or imaging examination. 4. Previous history of axillary surgery and trauma. 5. Allergic to iodine or indocyanine green. 6. Received preoperative drug therapy (including endocrine therapy and neoadjuvant chemotherapy). 7. Incomplete records of medical records. 8. Pregnant or lactating patients. 9. Patients suffering from serious underlying diseases such as heart, brain, kidney and/or mental illness.

Design outcomes

Primary

MeasureTime frame
Sentinel lymph node identification rate;The median number of metastatic sentinel lymph nodes identified by indocyanine green combined with blue dye, indocyanine green, and blue dye, respectively;

Secondary

MeasureTime frame
Metastatic sentinel lymph node identification rate;Sentinel lymph node visualization rate;Metastatic sentinel lymph node visualization rate;The median number of sentinel lymph nodes identified by indocyanine green combined with blue dye, indocyanine green, and blue dye, respectively;Operation time of sentinel lymph node biopsy;Postoperative incision infection rate;

Countries

China

Contacts

Public ContactZhang Pusheng

Zhujiang Hospital of Southern Medical University

drpushengz@163.com+86 13560028348

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026