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

NCT07672912 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-07-07

No results posted yet for this study

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.

Conditions

  • Non Palpable Cervical Lesions Suspicious for Metastasis

Interventions

PROCEDURE

Ultrasound-guided hook-wire localization

Preoperative ultrasound-guided placement of a hook-wire into or adjacent to a non-palpable or difficult-to-palpate cervical lesion to facilitate intraoperative identification and surgical excision of the target lesion.

PROCEDURE

Ultrasound-guided surgical excision alone

Surgical excision of the target cervical lesion using ultrasound guidance for intraoperative identification, without preoperative hook-wire localization.

Sponsors & Collaborators

  • Rusana Bark

    lead OTHER

Principal Investigators

  • Rusana Bark, Associate Professor, MD · Karolinska University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-15
Primary Completion
2025-11-21
Completion
2026-06-09

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07672912 on ClinicalTrials.gov