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Completed
NCT07672912
Ultrasound-Guided Hook-Wire Localization for Excision of Non-palpable Cervical Lesions Suspicious for Metastasis
Conditions: Non Palpable Cervical Lesions Suspicious for Metastasis
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 50
Sponsor: Rusana Bark
Location: Karolinska University Hospital Stockholm Stockholm County
Summary
The goal of this randomized controlled trial is to determine whether ultrasound-guided hook-wire localization improves surgical efficiency and accuracy compared with ultrasound-guided surgery alone for the excision of non-palpable or difficult-to-palpate cervical lesions suspicious for metastatic disease in adult patients.
The main questions it aims to answer are:
* Does ultrasound-guided hook-wire localization reduce operative time compared with ultrasound-guided excision alone?
* Does hook-wire localization improve surgical precision, including successful retrieval of the target lesion for histopathological assessment?
* Does hook-wire localization affect incision length, procedural difficulty, or the risk of surgical complications?
Researchers will compare patients undergoing ultrasound-guided hook-wire localization followed by surgical excision with patients undergoing ultrasound-guided excision alone to determine whether hook-wire guidance improves surgical outcomes.
Participants will:
* Undergo ultrasound-guided localization and surgical excision of a cervical lesion or lymph node suspicious for malignancy.
* Be randomly assigned to either: ultrasound-guided hook-wire localization before surgery, or ultrasound-guided excision without hook-wire localization.
* Have surgical outcomes assessed, including operative time, incision length, successful lesion retrieval, procedural difficulty, and intraoperative or postoperative complications.
Eligibility Criteria
Inclusion Criteria:
* Adults aged ≥18 years
* Patients with a cervical lesion or lymph node suspicious for malignancy based on fine-needle aspiration cytology (FNAC) and/or fluorodeoxyglucose positron emission tomography/computed tomography (FDG PET/CT) findings.
* Patients scheduled for surgical excision in general anesthesia of a non-palpable or difficult-to-palpate cervical lesion for definitive histopathological diagnosis.
* Patients able to provide informed consent.
Exclusion Criteria:
* Patients undergoing procedures planned under local anesthesia only.
* Patients not meeting the predefined surgical criteria for excision of a target cervical lesion.
* Patients with palpable cervical lesions suitable for direct surgical identification and excision without imaging guidance
* Patients unable to provide informed consent.
Source: ClinicalTrials.gov (NCT07672912). StuddyBuddy aggregates publicly available trial information.