The efficacy of radioguided occult lesion localisation (ROLL) versus wire guided lesion localisation (WGL) in breast conserving surgery for non palpable breast cancer: a randomised controlled trial
Phase 3
Completed
- Conditions
- breast cancerbreast carcinoma1000629110006295
- Registration Number
- NL-OMON35161
- Lead Sponsor
- niversitair Medisch Centrum Utrecht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 316
Inclusion Criteria
Patients with a non palpable breast carcinoma who are eligible for a lumpectomy and sentinel node biopsy
Exclusion Criteria
- Pregnant or lactating patients
- Patients with a multi focal carcinoma
- Patients with ductal carcinoma in situ (DCIS) or a lobular carcinoma in situ (LCIS) without invasive growth
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>1) The percentage of tumour-free margins (invasive and in situ) after the ROLL<br /><br>vs. the WGL procedure (i.e. oncologic outcome).<br /><br>2) The volume and maximum diameter of the lumpectomy of ROLL vs. WGL (i.e.<br /><br>cosmetic outcome).</p><br>
- Secondary Outcome Measures
Name Time Method <p>1) The cost-effectiveness of ROLL vs. WGL (i.e. operation time, radiological<br /><br>localisation time, hospital stay and materials).<br /><br>2) The degree of difficulty of the radiological and surgical procedure.<br /><br>3) The degree of patient (dis)comfort of the radiological procedure ROLL vs.<br /><br>WGL (number of procedures, pain, complications).<br /><br>4) The success rate of the sentinel node procedure (visualisation and<br /><br>localisation).</p><br>