Esta página se tradujo automáticamente y no se garantiza la precisión de la traducción. por favor refiérase a versión inglesa para un texto fuente.

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

2 de julio de 2026 actualizado por: 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.

Descripción general del estudio

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Actual)

50

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

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

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

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 de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Diagnóstico
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
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.
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.
Comparador activo: 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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Operative time
Periodo de tiempo: 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)

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Skin incision length
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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.

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Investigadores

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

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

15 de abril de 2021

Finalización primaria (Actual)

21 de noviembre de 2025

Finalización del estudio (Actual)

9 de junio de 2026

Fechas de registro del estudio

Enviado por primera vez

16 de junio de 2026

Primero enviado que cumplió con los criterios de control de calidad

22 de junio de 2026

Publicado por primera vez (Actual)

29 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

7 de julio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

2 de julio de 2026

Última verificación

1 de julio de 2026

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Descripción del plan 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.

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

Suscribir