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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.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07672912). StuddyBuddy aggregates publicly available trial information.