Interventional ductoscopy in patients with (premalignant) intraductal lesion(s)

Interventional ductoscopy in patients with (premalignant) intraductal lesion(s) - EVAPORATE

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON54094

Enrollment

Registered

2022-01-27

Start date

2022-10-05

Completion date

Unknown

Last updated

2024-04-15

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

Conditions

nipple fluid Pathological nipple discharge

Interventions

Patients with intraductal lesion(s) will undergo an intraductal biopsy with newly designed biopsy tools and laser ablation.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: • Women >=18 age • Patients with unilateral pathological nipple discharge • No radiological suspicion for malignancy • Referred to the UMC Utrecht for ductoscopy

Exclusion criteria

Exclusion criteria: • Pregnancy • History of breast surgery at the affected breast • History of radiotherapy of the breast or thorax • Nipple retraction making ductoscopy technically impossible • Not being able to sign an informed consent

Design outcomes

Primary

Measure	Time frame
Primary endpoints are to determine the number of intraductal lesions diagnosed and treated by using intraductal biopsy and laser ablation.	—

Secondary

Measure	Time frame
To analyze treatment success of interventional ductoscopy and quality of life after ductoscopy in patients with PND. Also, in patients who undergo surgery, to determine the accuracy of findings of biopsy and laser ablation during ductoscopy	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)