Bronchoscopic ICG Injection and Percutaneous Hook-wire Techniques for Preoperative Lung Nodule Localization in VATS

Overview

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.

Full Title of Study: “Bronchoscopic ICG Injection vs Percutaneous Hook-wire Techniques for Preoperative Lung Nodule Localization in Video-assisted Thoracoscopic Sublobar Resection: A Prospective and Randomized Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: None (Open Label)
  • Study Primary Completion Date: November 5, 2020

Detailed Description

This is a single-center, prospective, randomized trial initiated by the investigator. Subjects with pulmonary nodules who will undergo Video-assisted thoracoscopic sublobar resection will be randomly divided into two groups. In the experimental group, before the VATS operation, transbronchial ICG injection will be guided by electromagnetic navigation bronchoscopy to locate the nodule. In the control group, the subject will undergo CT guided hook-wire placement for nodule localization before VATS. The study is expected to enroll 188 patients. Finally, the effectiveness and safety of the two methods will be compared.

Interventions

  • Device: Indocyanine green (ICG)
    • Indocyanine green (ICG) was diluted with saline to 0.5mg/mL, and injected 0.6mL/site.
  • Device: 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.
  • Device: 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.

Arms, Groups and Cohorts

  • Experimental: 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.
  • Active Comparator: 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.

Clinical Trial Outcome Measures

Primary Measures

  • Success rate of the localization procedure
    • Time Frame: On the 1 day of localization operation
    • Calculated as follows: (number of successful targeting procedures/number of all localization procedures)*100
  • Success rate of the effective localization
    • Time Frame: On the 1 day of VATS operation
    • Calculated as follows: [(number of successful targeting procedures-number of dislodgements or unrecognized in the operative field)/number of all localization procedures]*100
  • Success rate of VATS sublobar resection
    • Time Frame: On the 1 day of VATS completion
    • Calculated as follows: (number of successful VATS procedures/number of all localization procedures)*100

Secondary Measures

  • Safety endpoint
    • Time Frame: On the 1 day of VATS operation
    • Complication rate of two localization methods, including pneumothorax, hemorrhage, etc.
  • Localization time
    • Time Frame: On the 1 day of localization operation
    • The localization time of the control group was defined as the time from the first CT scan which set the path for percutaneous puncture, to the last CT scan which confirmed the hook wire located at the expected site. The localization time of the experimental group was defined as the time from the insertion of bronchoscope to the glottis, to the withdrawal of bronchoscope from the glottis after ICG injection.
  • Operation time of VATS sublobar resection
    • Time Frame: On the 1 day of VATS completion
    • The operation time is defined as the time from the start of the skin incision to the completion of the suture of the skin.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Jiayuan Sun
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Jiayuan Sun, Director, Department of Endoscopy, Shanghai Chest Hospital – Shanghai Chest Hospital
  • Overall Official(s)
    • Jiayuan Sun, MD, Principal Investigator, Shanghai Chest Hospital
  • Overall Contact(s)
    • Jiayuan Sun, PhD, +86-021-22200000, jysun1976@163.com

References

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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. Review.

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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.

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