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

2 juillet 2026 mis à jour par: Rusana Bark

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.

Aperçu de l'étude

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Réel)

50

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La 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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Diagnostique
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
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.
Comparateur actif: 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.
Surgical excision of the target cervical lesion using ultrasound guidance for intraoperative identification, without preoperative hook-wire localization.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Operative time
Délai: During the surgical procedure (from ultrasound localization to wound closure)
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)

Mesures de résultats secondaires

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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Les enquêteurs

  • Chercheur principal: Rusana Bark, Associate Professor, MD, Karolinska University Hospital

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

15 avril 2021

Achèvement primaire (Réel)

21 novembre 2025

Achèvement de l'étude (Réel)

9 juin 2026

Dates d'inscription aux études

Première soumission

16 juin 2026

Première soumission répondant aux critères de contrôle qualité

22 juin 2026

Première publication (Réel)

29 juin 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

7 juillet 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

2 juillet 2026

Dernière vérification

1 juillet 2026

Plus d'information

Termes liés à cette étude

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Description du régime IPD

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.

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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