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

Open Lymph Node Biopsy in the Diagnostic Evaluation of Lymphoma and Non-palpable Cervical Cystic Lesions: a Clinical Study.

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.

Study Overview

• Status: Completed
• Conditions: Non Palpable Cervical Lesions Suspicious for Metastasis
• Intervention / Treatment: Procedure: Ultrasound-guided hook-wire localization; Procedure: Ultrasound-guided surgical excision alone

Detailed Description

This prospective randomized controlled trial evaluates whether ultrasound-guided hook-wire localization improves the surgical management of non-palpable or difficult-to-palpate cervical lesions suspicious for metastatic disease compared with ultrasound-guided surgical excision alone. The study was designed to investigate whether preoperative hook-wire localization can facilitate more efficient and accurate surgical removal of targeted cervical lesions while minimizing surgical burden.

Patients with cervical lesions or lymph nodes suspicious for malignancy based on fine-needle aspiration cytology (FNAC) and/or fluorodeoxyglucose positron emission tomography/computed tomography (FDG PET/CT) findings may require surgical excision to obtain definitive histopathological diagnosis or to guide further oncological management. However, non-palpable or poorly palpable cervical lesions can be challenging to identify intraoperatively, potentially resulting in longer operative procedures, larger incisions, increased tissue dissection, and difficulties in ensuring retrieval of the intended target lesion.

Ultrasound-guided hook-wire localization is a technique in which a thin wire is placed under ultrasound guidance into or adjacent to the target lesion before surgery, providing the surgeon with a physical marker to facilitate identification and excision. This approach is widely used for localization of non-palpable breast lesions but has been less extensively evaluated for cervical lesions. The present study investigates the clinical utility of this technique in cervical surgery.

The study was conducted at Karolinska University Hospital between April 2021 and November 2025. Adult patients (≥18 years) with cervical lesions or lymph nodes suspicious for malignancy who were scheduled for surgical excision of a non-palpable or difficult-to-palpate lesion for histopathological evaluation were eligible for inclusion. Most included patients had confirmed or suspected malignancy, and excisional lymph node biopsy represented the most common surgical procedure.

A total of 51 patients were randomized using sealed opaque envelopes to either ultrasound-guided hook-wire localization followed by surgical excision or ultrasound-guided excision alone. One patient was excluded after randomization due to a protocol violation, as the procedure was planned under local anesthesia and therefore did not meet the predefined inclusion criteria. To maintain balanced study groups, one additional patient was enrolled using a duplicate allocation envelope, resulting in a final study population of 50 patients, with 25 patients allocated to each study arm.

The primary objective was to determine whether hook-wire localization reduces operative time. Operative time was defined as the interval from the initial ultrasound localization of the target lesion to completion of wound closure. Secondary objectives included evaluation of surgical accuracy and feasibility through assessment of skin incision length, successful retrieval of the intended target lesion confirmed by histopathological examination, surgeon-rated procedural difficulty, and perioperative complications.

All participants were prospectively monitored for adverse events related to the procedure and surgery, including bleeding, infection, lymphatic leakage, and neurological injury. The study aims to provide evidence regarding whether ultrasound-guided hook-wire localization can improve surgical efficiency and precision in patients undergoing excision of challenging cervical lesions while maintaining procedural safety.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Stockholm County
    • Stockholm, Stockholm County, Sweden, 17176
      • Karolinska University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ultrasound-guided hook-wire localization arm; Participants assigned to this arm underwent ultrasound-guided hook-wire localization of the target cervical lesion prior to surgical excision. The hook-wire was used to guide intraoperative identification and removal of the non-palpable or difficult-to-palpate lesion.	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.
Active Comparator: Ultrasound-guided excision alone arm; Participants assigned to this arm underwent ultrasound-guided surgical excision of the target cervical lesion without preoperative hook-wire localization.	Procedure: Ultrasound-guided surgical excision alone; Surgical excision of the target cervical lesion using ultrasound guidance for intraoperative identification, without preoperative hook-wire localization.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Operative time	Operative time, defined as the time interval from initial ultrasound localization of the target cervical lesion to completion of wound closure. The outcome will be compared between participants undergoing ultrasound-guided hook-wire localization and those undergoing ultrasound-guided excision alone.	During the surgical procedure (from ultrasound localization to wound closure)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Skin incision length	Length of the surgical skin incision measured at the completion of the procedure.	Immediately after completion of surgery
Successful retrieval of target lesion	Successful identification and removal of the intended target cervical lesion, confirmed by histopathological examination of the surgical specimen.	Up to 4 weeks after surgical excision, when histopathology assessment is complete.
Surgeon-rated procedural difficulty	Assessment of procedural difficulty by the operating surgeon using a predefined evaluation scale.	During the surgical procedure.
Intraoperative complications	Occurrence of procedure-related intraoperative complications, including bleeding, injury to surrounding structures, or other adverse events occurring during surgery.	During the surgical procedure, reporting score on a 0-5 scale. Scale title: "Overall assessment of procedural difficulty": 1=very difficult and 5= very easy.
Postoperative complications	Occurrence of postoperative complications, including bleeding, infection, lymphatic leakage, and neurological injury following surgical excision.	up to 4 weeks after surgery

Collaborators and Investigators

• Sponsor: Rusana Bark
• Investigators: Principal Investigator: Rusana Bark, Associate Professor, MD, Karolinska University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2021
• Primary Completion (Actual): November 21, 2025
• Study Completion (Actual): June 9, 2026

Study Registration Dates

• First Submitted: June 16, 2026
• First Submitted That Met QC Criteria: June 22, 2026
• First Posted (Actual): June 29, 2026

Study Record Updates

• Last Update Posted (Actual): June 29, 2026
• Last Update Submitted That Met QC Criteria: June 22, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: head and neck neoplasms; Lymphatic metastasis; ultrasound-guided surgery,; hook-wire localization; non-palpable cervical lesions or lymph nodes; Histopathological Diagnosis
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Site; Neoplasms; Neoplastic Processes; Neoplasm Metastasis; Pathological Conditions, Signs and Symptoms; Head and Neck Neoplasms; Lymphatic Metastasis
• Other Study ID Numbers: Karolinska UH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The datasets generated and/or analyzed during the current study are not publicly available due to privacy and ethical restrictions but may be available from the corresponding author upon reasonable request and subject to appropriate approvals.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No