Non Palpable Cervical Lesions Suspicious for MetastasisNCT07672912
Ultrasound-Guided Hook-Wire Localization for Excision of Non-palpable Cervical Lesions Suspicious for Metastasis
A study testing Ultrasound-guided hook-wire localization and Ultrasound-guided surgical excision alone in people with Non Palpable Cervical Lesions Suspicious for Metastasis, run by Rusana Bark at 1 site in Sweden.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Palpable Cervical Lesions Suspicious for Metastasis
- What is being tested?
- Ultrasound-guided hook-wire localization and Ultrasound-guided surgical excision alone
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSweden
- Study dates
- 15 Apr 2021to 9 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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:
Read more
- 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.
Read the 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.
- Being tested
- Ultrasound-guided hook-wire localization, Ultrasound-guided surgical excision alone
- Keywords
- ultrasound-guided surgery,, hook-wire localization, non-palpable cervical lesions or lymph nodes, head and neck neoplasms, Lymphatic metastasis, Histopathological Diagnosis
- Medical subject headings
- Head and Neck Neoplasms, Lymphatic Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-guided hook-wire localizationProcedure or surgery
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.
Ultrasound-guided surgical excision aloneProcedure or surgery
Surgical excision of the target cervical lesion using ultrasound guidance for intraoperative identification, without preoperative hook-wire localization.
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound-guided hook-wire localization arm | Experimental | 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. Receives: Procedure: Ultrasound-guided hook-wire localization |
| Ultrasound-guided excision alone arm | Active comparator | Participants assigned to this arm underwent ultrasound-guided surgical excision of the target cervical lesion without preoperative hook-wire localization. Receives: Procedure: Ultrasound-guided surgical excision alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During the surgical procedure (from ultrasound localization to wound closure)
Secondary outcomes (5)
Skin incision length
Length of the surgical skin incision measured at the completion of the procedure.
Measured: 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.
Measured: 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, reporting score on a 0-5 scale. Scale title: "Overall assessment of procedural difficulty": 1=very difficult and 5= very easy.
Measured: 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.
Measured: During the surgical procedure.
Postoperative complications
Occurrence of postoperative complications, including bleeding, infection, lymphatic leakage, and neurological injury following surgical excision.
Measured: up to 4 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2026
- Study start15 Apr 2021
- Primary completion21 Nov 2025
- Study completion9 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Palpable Cervical Lesions Suspicious for MetastasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomly assigned in a 1:1 ratio to one of two parallel study groups. The intervention group underwent ultrasound-guided hook-wire localization followed by surgical excision of the target cervical lesion, while the control group underwent ultrasound-guided surgical excision alone. Participants were followed prospectively for assessment of surgical outcomes, including operative time, incision length, target lesion retrieval, procedural difficulty, and perioperative complications.
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rusana Bark
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Rusana Bark, Karolinska University Hospital
- Investigators
- Rusana Bark, Associate Professor, MD, Principal investigator, Karolinska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07672912
- Sponsor's protocol ID
- Karolinska UH
- Status last verified
- Jul 2026
- First submitted
- 16 Jun 2026
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Lymph Node Biopsy in the Diagnostic Evaluation of Lymphoma and Non-palpable Cervical Cystic Lesions: a Clinical Study.
- ClinicalTrials.gov ID
- NCT07672912
- Acronym / sponsor ID
- Karolinska UH
- Keywords
- ultrasound-guided surgery,, hook-wire localization, non-palpable cervical lesions or lymph nodes, head and neck neoplasms, Lymphatic metastasis, Histopathological Diagnosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Rusana BarkUniversity, hospital or other
- Study start
- 15 Apr 2021 (actual)
- Primary completion
- 21 Nov 2025 (actual)
- Study completion
- 9 Jun 2026 (actual)
- First posted
- 29 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants were randomly assigned in a 1:1 ratio to one of two parallel study groups. The intervention group underwent ultrasound-guided hook-wire localization followed by surgical excision of the target cervical lesion, while the control group underwent ultrasound-guided surgical excision alone. Participants were followed prospectively for assessment of surgical outcomes, including operative time, incision length, target lesion retrieval, procedural difficulty, and perioperative complications.
| Arm | Type | Receives |
|---|---|---|
| Ultrasound-guided hook-wire localization arm | Experimental | Procedure: Ultrasound-guided hook-wire localizationParticipants 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. |
| Ultrasound-guided excision alone arm | Active comparator | Procedure: Ultrasound-guided surgical excision aloneParticipants assigned to this arm underwent ultrasound-guided surgical excision of the target cervical lesion without preoperative hook-wire localization. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound-guided hook-wire localizationPreoperative 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 or surgery | Ultrasound-guided hook-wire localization arm |
| Ultrasound-guided surgical excision aloneSurgical excision of the target cervical lesion using ultrasound guidance for intraoperative identification, without preoperative hook-wire localization. | Procedure or surgery | Ultrasound-guided excision alone arm |
Primary outcome
Operative time
Time frame: 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.
5 secondary outcomes
Skin incision length
Time frame: Immediately after completion of surgery
Successful retrieval of target lesion
Time frame: Up to 4 weeks after surgical excision, when histopathology assessment is complete.
Surgeon-rated procedural difficulty
Time frame: During the surgical procedure.
Intraoperative complications
Time frame: During the surgical procedure.
Postoperative complications
Time frame: up to 4 weeks after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Individual participant dataSharing planned: No. 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rusana Bark, Associate Professor, MD principal investigator
Karolinska University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound-guided hook-wire localization and Ultrasound-guided surgical excision alone in people with Non Palpable Cervical Lesions Suspicious for Metastasis, run by Rusana Bark at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Operative time (time frame: During the surgical procedure (from ultrasound localization to wound closure)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.