The primary objective is to assess the feasibility of intraductal biopsy and intraductal laser ablation in patients with intraductal lesions. Secondary objectives are: treatment success of interventional ductoscopy (biopsy and laser ablation) in…
ID
Source
Brief title
Condition
- Breast therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoints are to determine the number of intraductal lesions diagnosed
and treated by using intraductal biopsy and laser ablation.
Secondary outcome
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
Background summary
Ductoscopy is a minimally invasive micro-endoscopic approach for direct
visualization of intraductal lesions of the breast. One of the limitations of
ductoscopy is that the current biopsy tool is not sufficiently accurate to
obtain biopsy for pathology to confirm what is seen during ductoscopy. This
could lead to overtreatment when a visual diagnosis is uncertain. Therefore,
new intraductal biopsy tools were developed to perform this biopsy.
Additionally, it would be interesting to perform an intraductal laser ablation
for lesions that are unable to extract with the biopsy devices. In this study,
we will analyze two new implementations to enhance the interventional
ductoscopy technique: new intraductal biopsy tools and intraductal laser
ablation in patients with (premalignant) intraductal lesions. The main aims of
the present study are to improve diagnostic accuracy and therapeutic efficacy
of interventional ductoscopy in patients with PND and to explore the
feasibility of the new implementations in diagnosing and removing intraductal
precursor lesions. We hypothesize that the newly developed biopsy tools and
laser ablation will enhance the technique to perform a biopsy and remove
(premalignant) intraductal lesions more specifically.
Study objective
The primary objective is to assess the feasibility of intraductal biopsy and
intraductal laser ablation in patients with intraductal lesions. Secondary
objectives are: treatment success of interventional ductoscopy (biopsy and
laser ablation) in treating pathological nipple discharge (PND), to analyze the
effectivity of intraductal biopsy and laser ablation in completely removal of
the intraductal lesion(s).
Study design
A prospective, single-center, diagnostic feasibility study.
Intervention
Patients with intraductal lesion(s) will undergo an intraductal biopsy with
newly designed biopsy tools and laser ablation.
Study burden and risks
The study population will not have any diasadvantage of participation. Patients
who are already eligible for ductoscopy will not have additional examinations
and/or visits. The ductoscopy procedure will take 10 minutes more than usual.
Heidelberglaan 100
Utrecht 3584CX
NL
Heidelberglaan 100
Utrecht 3584CX
NL
Listed location countries
Age
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
Design
Recruitment
Medical products/devices used
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| CCMO | NL77552.041.21 |