Ultrasound-Guided Hook-Wire Localization for Excision of Non-palpable Cervical Lesions Suspicious for Metastasis

Authors
Category Primary study
Registry of TrialsClinicalTrials.gov
Year 2026
This prospective randomized controlled trial evaluates whether ultrasound‐guidedhook‐wire localization improves the surgical management of non‐palpable ordifficult‐to‐palpate cervical lesions suspicious for metastatic disease compared withultrasound‐guided surgical excision alone. The study was designed to investigate whetherpreoperative hook‐wire localization can facilitate more efficient and accurate surgicalremoval of targeted cervical lesions while minimizing surgical burden.Patients with cervical lesions or lymph nodes suspicious for malignancy based onfine‐needle aspiration cytology (FNAC) and/or fluorodeoxyglucose positron emissiontomography/computed tomography (FDG PET/CT) findings may require surgical excision toobtain definitive histopathological diagnosis or to guide further oncological management.However, non‐palpable or poorly palpable cervical lesions can be challenging to identifyintraoperatively, potentially resulting in longer operative procedures, larger incisions,increased tissue dissection, and difficulties in ensuring retrieval of the intendedtarget lesion.Ultrasound‐guided hook‐wire localization is a technique in which a thin wire is placedunder ultrasound guidance into or adjacent to the target lesion before surgery, providingthe surgeon with a physical marker to facilitate identification and excision. Thisapproach is widely used for localization of non‐palpable breast lesions but has been lessextensively evaluated for cervical lesions. The present study investigates the clinicalutility of this technique in cervical surgery.The study was conducted at Karolinska University Hospital between April 2021 and November2025. Adult patients (≥18 years) with cervical lesions or lymph nodes suspicious formalignancy who were scheduled for surgical excision of a non‐palpable ordifficult‐to‐palpate lesion for histopathological evaluation were eligible for inclusion.Most included patients had confirmed or suspected malignancy, and excisional lymph nodebiopsy represented the most common surgical procedure.A total of 51 patients were randomized using sealed opaque envelopes to eitherultrasound‐guided hook‐wire localization followed by surgical excision orultrasound‐guided excision alone. One patient was excluded after randomization due to aprotocol violation, as the procedure was planned under local anesthesia and therefore didnot meet the predefined inclusion criteria. To maintain balanced study groups, oneadditional patient was enrolled using a duplicate allocation envelope, resulting in afinal study population of 50 patients, with 25 patients allocated to each study arm.The primary objective was to determine whether hook‐wire localization reduces operativetime. Operative time was defined as the interval from the initial ultrasound localizationof the target lesion to completion of wound closure. Secondary objectives includedevaluation of surgical accuracy and feasibility through assessment of skin incisionlength, successful retrieval of the intended target lesion confirmed by histopathologicalexamination, surgeon‐rated procedural difficulty, and perioperative complications.All participants were prospectively monitored for adverse events related to the procedureand surgery, including bleeding, infection, lymphatic leakage, and neurological injury.The study aims to provide evidence regarding whether ultrasound‐guided hook‐wirelocalization can improve surgical efficiency and precision in patients undergoingexcision of challenging cervical lesions while maintaining procedural safety.
Epistemonikos ID: ee8a1f37abf84cdba3616ec00590f034bf5c4321
First added on: Jun 30, 2026