Bronchoscopic ICG Injection and Percutaneous Hook-wire Techniques for Preoperative Lung Nodule Localization in VATS
NCT ID: NCT04182152
Last Updated: 2019-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
188 participants
INTERVENTIONAL
2019-11-05
2020-12-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Bronchoscopic ICG localization
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.
Indocyanine green (ICG)
Indocyanine green (ICG) was diluted with saline to 0.5mg/mL, and injected 0.6mL/site.
Electromagnetic navigation bronchoscopy
Electromagnetic navigation bronchoscopy (ENB) allows physicians to access peripheral lung nodules with high accuracy and provides a working channel for ICG injection.
percutaneous hook-wire localization
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.
Hook wire
Hook wire is a puncture locating needle with a hook head that is about 1 cm in length and 30 cm metal wire behind. Through the puncture path planned based on CT scan, hook wire puncture percutaneously into the chest cavity to reach the lesion for localization.
Interventions
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Indocyanine green (ICG)
Indocyanine green (ICG) was diluted with saline to 0.5mg/mL, and injected 0.6mL/site.
Electromagnetic navigation bronchoscopy
Electromagnetic navigation bronchoscopy (ENB) allows physicians to access peripheral lung nodules with high accuracy and provides a working channel for ICG injection.
Hook wire
Hook wire is a puncture locating needle with a hook head that is about 1 cm in length and 30 cm metal wire behind. Through the puncture path planned based on CT scan, hook wire puncture percutaneously into the chest cavity to reach the lesion for localization.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Jiayuan Sun
OTHER
Responsible Party
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Jiayuan Sun
Director, Department of Endoscopy, Shanghai Chest Hospital
Principal Investigators
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Jiayuan Sun, MD
Role: PRINCIPAL_INVESTIGATOR
Shanghai Chest Hospital
Locations
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Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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References
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Altorki 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.
Park 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.
Zhang 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.
Sun 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.
Sekine 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.
Anayama 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.
Abbas A, Kadakia S, Ambur V, Muro K, Kaiser L. Intraoperative electromagnetic navigational bronchoscopic localization of small, deep, or subsolid pulmonary nodules. J Thorac Cardiovasc Surg. 2017 Jun;153(6):1581-1590. doi: 10.1016/j.jtcvs.2016.12.044. Epub 2017 Feb 7.
Hyun K, Park IK, Song JW, Park S, Kang CH, Kim YT. Electromagnetic navigation bronchoscopic dye marking for localization of small subsolid nodules: Retrospective observational study. Medicine (Baltimore). 2019 Mar;98(11):e14831. doi: 10.1097/MD.0000000000014831.
Anayama T, Hirohashi K, Miyazaki R, Okada H, Kawamoto N, Yamamoto M, Sato T, Orihashi K. Near-infrared dye marking for thoracoscopic resection of small-sized pulmonary nodules: comparison of percutaneous and bronchoscopic injection techniques. J Cardiothorac Surg. 2018 Jan 12;13(1):5. doi: 10.1186/s13019-018-0697-6.
Other Identifiers
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SHCHE201905
Identifier Type: -
Identifier Source: org_study_id
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