Clinical trial · Interventional
Bronchoscopic ICG Injection and Percutaneous Hook-wire Techniques for Preoperative Lung Nodule Localization in VATS
Bronchoscopic ICG Injection vs Percutaneous Hook-wire Techniques for Preoperative Lung Nodule Localization in Video-assisted Thoracoscopic Sublobar Resection: A Prospective and Randomized Trial
NCT04182152CI-TRIAL-00042013unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of the study is to evaluate the efficacy and safety of transbronchial ICG and percutaneous hook-wire assisted Video-assisted thoracoscopic sublobar resection. In the control group, CT-guided percutaneous hook-wire preoperative localization will be used for surgical resection; In the experimental group, electromagnetic navigation bronchoscopy guided transbronchial ICG injection will be performed for localization before VATS.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Electromagnetic navigation bronchoscopy | Device | — | UNRESOLVED |
| Hook wire | Device | — | UNRESOLVED |
| Indocyanine green (ICG) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Bronchoscopic ICG localization
- description
- The nodule will be located preoperatively by ENB-Guided bronchoscopic ICG injection; During the VATS operation, a near-infrared fluorescence thoracoscopy will be used to identify ICG distribution in the visceral pleura to guide an accurate surgical resection.
- interventionNames
- Device: Indocyanine green (ICG)
- Device: Electromagnetic navigation bronchoscopy
- type
- ACTIVE_COMPARATOR
- label
- percutaneous hook-wire localization
- description
- The nodule will be located preoperatively by percutaneous placement of hook wire; During the VATS operation, the resection scope is determined by the location relationship between hook wire and the nodule under CT scan.
- interventionNames
- Device: Hook wire
Primary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Above 18 years old; * With lung nodule diameter ≤2cm and distance from pleura ≥1cm, and VATS sublobar resection is arranged; * Located difficultly by intraoperative visual inspection and palpation, a preoperative location is needed. Exclusion Criteria: * Cardiopulmonary function cannot tolerate general anesthesia, or other contraindications, such as uncorrectable coagulopathy; * More than one pulmonary nodule requires preoperative localization; * Subject underwent thoracic surgery in the past and was suspected of having severe chest adhesions; * The nodule puncture path has bony structure block; * Others conditions that the investigator considers not appropriate for this trial.
References
Publications (9)
- BACKGROUNDAltorki N, Shostak E. Localizing small nodules: Is it time for a randomized trial? J Thorac Cardiovasc Surg. 2017 Jun;153(6):1591. doi: 10.1016/j.jtcvs.2017.02.037. Epub 2017 Mar 8. No abstract available. PMID 28343689
- BACKGROUNDPark CH, Han K, Hur J, Lee SM, Lee JW, Hwang SH, Seo JS, Lee KH, Kwon W, Kim TH, Choi BW. Comparative Effectiveness and Safety of Preoperative Lung Localization for Pulmonary Nodules: A Systematic Review and Meta-analysis. Chest. 2017 Feb;151(2):316-328. doi: 10.1016/j.chest.2016.09.017. Epub 2016 Oct 4. PMID 27717643
- BACKGROUNDZhang L, Wang L, Kadeer X, Zeyao L, Sun X, Sun W, She Y, Xie D, Li M, Zou L, Rocco G, Yang P, Chen C, Liu CC, Petersen RH, Ng CSH, Parrish S, Zhang YS, Giordano R, di Tommaso L; AME Thoracic Surgery Collaborative Group. Accuracy of a 3-Dimensionally Printed Navigational Template for Localizing Small Pulmonary Nodules: A Noninferiority Randomized Clinical Trial. JAMA Surg. 2019 Apr 1;154(4):295-303. doi: 10.1001/jamasurg.2018.4872. PMID 30586136
- BACKGROUNDSun J, Mao X, Xie F, Han B, Chen H. Electromagnetic navigation bronchoscopy guided injection of methylene blue combined with hookwire for preoperative localization of small pulmonary lesions in thoracoscopic surgery. J Thorac Dis. 2015 Dec;7(12):E652-6. doi: 10.3978/j.issn.2072-1439.2015.12.24. PMID 26793384
- BACKGROUNDSekine Y, Ko E, Oishi H, Miwa M. A simple and effective technique for identification of intersegmental planes by infrared thoracoscopy after transbronchial injection of indocyanine green. J Thorac Cardiovasc Surg. 2012 Jun;143(6):1330-5. doi: 10.1016/j.jtcvs.2012.01.079. Epub 2012 Feb 22. PMID 22361249
- BACKGROUNDAnayama T, Qiu J, Chan H, Nakajima T, Weersink R, Daly M, McConnell J, Waddell T, Keshavjee S, Jaffray D, Irish JC, Hirohashi K, Wada H, Orihashi K, Yasufuku K. Localization of pulmonary nodules using navigation bronchoscope and a near-infrared fluorescence thoracoscope. Ann Thorac Surg. 2015 Jan;99(1):224-30. doi: 10.1016/j.athoracsur.2014.07.050. Epub 2014 Nov 6.