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.
調査の概要
状態
状態
条件
条件
介入・治療
介入・治療
詳細な説明
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.
研究の種類
研究の種類
入学 (実際)
入学
段階
段階
- 適用できない
連絡先と場所
研究場所
-
-
Stockholm County
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Stockholm、Stockholm County、スウェーデン、17176
- Karolinska University Hospital
-
-
参加基準
適格基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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.
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:診断
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:なし(オープンラベル)
アーム数
武器と介入
参加者グループ / アーム参加者グループ / アーム |
介入・治療介入・治療 |
|---|---|
|
実験的: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.
|
|
アクティブコンパレータ: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.
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この研究は何を測定していますか?
主要な結果の測定
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Operative time
時間枠: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)
|
二次結果の測定
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Skin incision length
時間枠:Immediately after completion of surgery
|
Length of the surgical skin incision measured at the completion of the procedure.
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Immediately after completion of surgery
|
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Successful retrieval of target lesion
時間枠:Up to 4 weeks after surgical excision, when histopathology assessment is complete.
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Successful identification and removal of the intended target cervical lesion, confirmed by histopathological examination of the surgical specimen.
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Up to 4 weeks after surgical excision, when histopathology assessment is complete.
|
|
Postoperative complications
時間枠:up to 4 weeks after surgery
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Occurrence of postoperative complications, including bleeding, infection, lymphatic leakage, and neurological injury following surgical excision.
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up to 4 weeks after surgery
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|
Surgeon-rated procedural difficulty
時間枠:During the surgical procedure.
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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.
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During the surgical procedure.
|
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Intraoperative complications
時間枠:During the surgical procedure.
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Occurrence of procedure-related intraoperative complications, including bleeding, injury to surrounding structures, or other adverse events occurring during surgery.
|
During the surgical procedure.
|
協力者と研究者
捜査官
捜査官
- 主任研究者:Rusana Bark, Associate Professor, MD、Karolinska University Hospital
研究記録日
主要日程の研究
研究開始 (実際)
研究開始
一次修了 (実際)
一次修了
研究の完了 (実際)
研究の完了
試験登録日
最初に提出
最初に提出
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
最初の投稿 (実際)
最初の投稿
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
QC基準を満たした最後の更新が送信されました
QC基準を満たした最後の更新が送信されました
最終確認日
最終確認日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
その他の研究ID番号
- Karolinska UH
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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