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

Phase 2

Recruiting

• Conditions: nipple fluid; Pathological nipple discharge; 10006295

• Registration Number: NL-OMON54094
• Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 25

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

• 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoints are to determine the number of intraductal lesions diagnosed<br /><br>and treated by using intraductal biopsy and laser ablation.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>To analyze treatment success of interventional ductoscopy and quality of life<br /><br>after ductoscopy in patients with PND. Also, in patients who undergo surgery,<br /><br>to determine the accuracy of findings of biopsy and laser ablation during<br /><br>ductoscopy</p><br>