Major duct excision (Microdochectomy) for abnormal nipple discharge guided by real time ICG fluorescence imaging technique

JRCT ID: jRCTs071240081

Registered date:05/12/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: abnormal nipple discharge
• Date of first enrollment: 05/12/2024
• Target sample size: 20
• Study type: Interventional
• Intervention(s): Microdochectomy is performed to identify breast cancer with abnormal nipple discharge. First, the ducts with abnormal secretion are identified, cannulated, injected with dye (indigocarmine) and ICG into dilated duct with nipple discharge, and the incision perform beside the main duct of the nipple. After staining the duct with dye, and the CDD camera is used to identify the duct acording to injected ICG flows, then stainded duct are be removed along with surrounding gland lobes. Real time ICG imaging of the fluorescent method with ICG is used for exploring and identifying the responsibility duct accurately. In addition, the surgery specimens will be examined for conforming the causative disease and disected margins by pathohistrogical study.

Outcome(s)

• Primary Outcome: The accuracy rate of ICG fluorescence identificated the ducts and adenohypophysis areas causing nipple secretions.

Secondary Outcome

1. Pathological diagnosis and surgical margin status
2. Safety events

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Female

Include criteria

(1) Patients who have abnormal nipple discharge for microdochectomy
(2) Paticipants have completed the whriten informed consent for this study

Exclude criteria

(1) Paticipants who are allergic to the agents to be used
(2) Paticipants who are deemed inappropriate as research subjects by the principal investigator and research coordinators

Related Information

• Primary Sponsor: Toh Uhi