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Intraoperative Longitude-Latitude-Depth Localization Versus Preoperative CT-Guided Percutaneous Lung Puncture Localization for 0.8-2 cm Peripheral Pulmonary Nodules

2026年6月23日 更新者：Zhenguo Sun、Qilu Hospital of Shandong University

Intraoperative Longitude-Latitude-Depth Three-Dimensional Localization Versus Preoperative CT-Guided Percutaneous Lung Puncture Localization for the Treatment of 0.8-2 cm Peripheral Pulmonary Nodules: A Multicenter, Randomized, Open-Label, Non-Inferiority Clinical Trial

The goal of this clinical trial is to learn whether intraoperative longitude-latitude-depth three-dimensional localization (LLD localization) is non-inferior to preoperative CT-guided percutaneous lung puncture localization for identifying 0.8-2 cm peripheral pulmonary nodules in adults undergoing video-assisted thoracoscopic surgery (VATS)-assisted sublobar resection. It will also evaluate the safety and perioperative effectiveness of the two localization methods. The main questions it aims to answer are:

  1. Is the localization accuracy rate of LLD localization non-inferior to that of CT-guided percutaneous lung puncture localization?
  2. Does LLD localization improve perioperative outcomes, including localization time, postoperative recovery, pain, quality of life, and perioperative complication rates?

Researchers will compare LLD localization with CT-guided percutaneous lung puncture localization to determine whether LLD localization provides comparable localization accuracy while reducing procedure-related complications and improving perioperative outcomes.

Participants will:

  1. Be randomly assigned in a 1:1 ratio to either the LLD localization group or the CT-guided percutaneous lung puncture localization group.
  2. Undergo pulmonary nodule localization using the assigned localization method.
  3. Receive VATS-assisted sublobar resection following localization.
  4. Be assessed for localization accuracy, perioperative complications, localization time, postoperative chest drainage tube removal time, oxygenation index, postoperative hospital stay, pain scores, and quality-of-life outcomes.
  5. Complete follow-up assessments at 1, 3, and 6 months after surgery.

調査の概要

状態

まだ募集していません

条件

介入・治療

詳細な説明

Peripheral pulmonary nodules, particularly small subsolid nodules, are increasingly detected due to the widespread use of low-dose computed tomography (CT) screening. Accurate intraoperative identification of these nodules remains challenging during video-assisted thoracoscopic surgery because many lesions are difficult to visualize or palpate after lung collapse. Reliable localization is therefore essential to facilitate precise sublobar resection while preserving healthy lung tissue.

Preoperative CT-guided percutaneous localization techniques are widely used in clinical practice. However, these procedures require additional preoperative intervention and may be associated with complications such as pneumothorax, pulmonary hemorrhage, hemothorax, patient discomfort, and increased procedural complexity. Furthermore, successful localization depends on radiologic resources and coordination between multiple departments.

The longitude-latitude-depth (LLD) localization method is a novel intraoperative three-dimensional localization strategy developed to identify pulmonary nodules using anatomical reference lines and preoperative imaging measurements. The method utilizes the natural longitudinal and transverse landmarks of the collapsed lung together with the measured depth of the target lesion to estimate the spatial location of the nodule during surgery. Because localization is performed intraoperatively without transcutaneous puncture, the technique has the potential to reduce procedure-related trauma and simplify the clinical workflow.

Preliminary clinical experience suggests that the LLD localization method may provide accurate localization while avoiding several limitations associated with preoperative puncture-based approaches. However, high-quality prospective evidence comparing this technique with current standard localization methods remains limited.

This multicenter randomized controlled trial has been designed to provide rigorous clinical evidence regarding the performance of the LLD localization technique. The study will evaluate whether this novel approach can serve as an effective alternative to conventional CT-guided localization and support broader clinical application in the surgical management of peripheral pulmonary nodules.

研究の種類

介入

入学 (推定)

274

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

  • 名前：Zhenguo Sun, Doctor of Medicine (MD)
  • 電話番号：+86-185-6008-9136
  • メール：sunzg@sdu.edu.cn

研究場所

  • 中国
    • Guizhou
      • Xingyi、Guizhou、中国、562400
        • Xingyi People's Hospital
        • コンタクト：
    • Ningxia
      • Yinchuan、Ningxia、中国、750021
        • Ningxia Hui Autonomous Region People's Hospital
        • コンタクト：
          • Xiaowen Wang, Master of Medicine (M.M.)
          • 電話番号：+86-152-0269-2511
          • メール：506895970@qq.com
    • Shandong
      • Jinan、Shandong、中国、250012
        • Qilu Hospital of Shandong University
        • コンタクト：
      • Linqing、Shandong、中国、252600
        • Linqing People's Hospital
        • コンタクト：

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

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

いいえ

説明

Inclusion Criteria:

  • Clinically diagnosed pulmonary nodule by non-contrast chest CT.
  • Age 18 to 80 years.
  • Expected survival time of at least 12 months.
  • Single peripheral pulmonary nodule with a diameter between 0.8 cm and 2 cm.

  • Chest CT characteristics meeting both of the following criteria:

    1. Solid component proportion ≤50%.
    2. Located subpleurally or in the outer one-third of the lung parenchyma.
  • Willing to undergo VATS-assisted sublobar resection.
  • No contraindications to pulmonary localization procedures or surgery.
  • Able to understand the study and willing to sign written informed consent.

Exclusion Criteria:

  • Use of other localization methods or other surgical procedures.
  • Concurrent participation in another clinical study.
  • Pregnancy.
  • Unwillingness or inability to cooperate with participation in this study for any reason.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

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：処理
  • 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）

武器と介入

参加者グループ / アーム
介入・治療
実験的：Longitude-Latitude-Depth Localization Group
Participants assigned to this arm will undergo intraoperative longitude-latitude-depth (LLD) localization of peripheral pulmonary nodules. The localization method uses anatomical reference lines and preoperative imaging measurements to determine the three-dimensional position of the target nodule during surgery. Following localization, participants will undergo video-assisted thoracoscopic surgery (VATS)-assisted sublobar resection according to standard surgical practice.
手順：Longitude-Latitude-Depth Localization
The longitude-latitude-depth (LLD) localization method is a novel intraoperative three-dimensional pulmonary nodule localization technique developed for peripheral pulmonary nodules. Based on preoperative computed tomography (CT) imaging, the target lesion is characterized according to its longitudinal position, transverse position, and depth relative to the visceral pleural surface. During surgery, corresponding anatomical landmarks on the collapsed lung are identified, and the projected surface location and lesion depth are used to estimate the three-dimensional position of the target nodule. Localization is performed intraoperatively without preoperative transcutaneous puncture or placement of localization materials. The identified localization point is subsequently used to guide video-assisted thoracoscopic surgery (VATS)-assisted sublobar resection of the target lesion.
アクティブコンパレータ：CT-Guided Percutaneous Lung Puncture Localization Group
Participants assigned to this arm will undergo preoperative CT-guided percutaneous pulmonary nodule localization according to institutional standard practice. Following localization, participants will undergo video-assisted thoracoscopic surgery (VATS)-assisted sublobar resection according to standard surgical practice.
手順：CT-Guided Percutaneous Lung Puncture Localization
CT-guided percutaneous lung puncture localization is a preoperative localization procedure performed under computed tomography guidance. A localization device is inserted through the chest wall into the lung parenchyma to mark the location of the target pulmonary nodule before surgery. Following localization, the position of the marker relative to the nodule is confirmed by CT imaging. The localization result is subsequently used to guide video-assisted thoracoscopic surgery (VATS)-assisted sublobar resection.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Localization Accuracy Rate
時間枠：Intraoperatively on day 0.

Localization accuracy rate is defined as the percentage of participants with successful localization, calculated as (number of successfully localized participants / total number of participants) × 100%. Localization is deemed successful if the actual distance between the localization point and the true nodule center, or its surface projection, is 1 cm or less. A distance exceeding 1 cm is classified as localization failure.

After removal of the pulmonary nodule, measure the distance from the nodule center to the marked localization point with a ruler and record the value.
Intraoperatively on day 0.

二次結果の測定

結果測定
メジャーの説明
時間枠
Perioperative Complication Rate
時間枠：From the initiation of the localization procedure through hospital discharge, up to 14 days post-surgery.
The perioperative complication rate is defined as the proportion of participants experiencing one or more procedure-related or surgery-related complications during the perioperative period. Complications include, but are not limited to, pneumothorax, hemothorax, pulmonary hemorrhage, hemoptysis, prolonged air leak, and other adverse events requiring medical intervention.
From the initiation of the localization procedure through hospital discharge, up to 14 days post-surgery.
Localization Time
時間枠：During the localization procedure on day 0 (from the start of localization to its confirmed completion, approximately 5-20 minutes).
Localization time is defined as the time required to complete the pulmonary nodule localization procedure. For the LLD group, localization time is measured from initiation of intraoperative localization to successful identification of the localization point. For the CT-guided localization group, localization time is measured from initiation of the CT-guided localization procedure to completion of localization confirmation. The outcome will be reported in minutes.
During the localization procedure on day 0 (from the start of localization to its confirmed completion, approximately 5-20 minutes).
Postoperative Chest Drainage Tube Removal Time
時間枠：From the completion of surgery to chest drainage tube removal, assessed up to 14 days post-surgery.
Chest drainage tube removal time is defined as the interval between completion of surgery and removal of the postoperative chest drainage tube according to institutional postoperative management criteria. The outcome will be reported in days. A shorter duration indicates faster postoperative recovery.
From the completion of surgery to chest drainage tube removal, assessed up to 14 days post-surgery.
Oxygenation Index
時間枠：Postoperative day 1 and day 2.
The oxygenation index is calculated as the ratio of arterial oxygen partial pressure (PaO₂) to the fraction of inspired oxygen (FiO₂). Higher values indicate better pulmonary oxygenation function. The outcome will be reported as the PaO₂/FiO₂ ratio measured from arterial blood gas analysis.
Postoperative day 1 and day 2.
Postoperative Length of Hospital Stay
時間枠：From the completion of surgery to hospital discharge, assessed up to 30 days.
Postoperative length of hospital stay is defined as the number of days from completion of surgery until hospital discharge. The outcome will be reported in days. A shorter hospital stay indicates faster postoperative recovery and resource utilization efficiency.
From the completion of surgery to hospital discharge, assessed up to 30 days.
Postoperative Pain Score (VAS)
時間枠：Postoperative day 1, day 2, day 3, and day 7.
The Visual Analogue Scale (VAS) is used to assess postoperative pain intensity. Participants rate their pain on a scale ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable. Higher scores indicate greater pain severity. The outcome will be reported as the mean VAS score at each assessment time point.
Postoperative day 1, day 2, day 3, and day 7.
Quality of Life Score (EORTC QLQ-C30)
時間枠：Postoperative month 1, month 3, and month 6.
The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) is used to assess health-related quality of life. The questionnaire includes functional scales, symptom scales, and a global health status scale. Scores are transformed to a 0-100 scale according to the EORTC scoring manual. For functional scales and global health status, higher scores indicate better functioning and quality of life. For symptom scales, higher scores indicate greater symptom burden and worse quality of life.
Postoperative month 1, month 3, and month 6.

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Qilu Hospital of Shandong University

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年7月1日

一次修了 (推定)

2028年7月1日

研究の完了 (推定)

2028年7月1日

試験登録日

最初に提出

2026年6月23日

QC基準を満たした最初の提出物

2026年6月23日

最初の投稿 (実際)

2026年6月30日

学習記録の更新

投稿された最後の更新 (実際)

2026年6月30日

QC基準を満たした最後の更新が送信されました

2026年6月23日

最終確認日

2026年6月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • KYLL-2026-03-003-1

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?

いいえ

IPD プランの説明

To protect participant privacy and maintain clinical data confidentiality, individual participant data will not be made publicly available.

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