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

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04182152
• Other study ID #: SHCHE201905
• Status: Recruiting
• Phase: N/A
• Start date: November 5, 2019
• Est. completion date: December 5, 2020

Study information

• Verified date: November 2019
• Source: Shanghai Chest Hospital
• Contact: Jiayuan Sun, PhD
• Phone: +86-021-22200000
• Email: jysun1976[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 188
• Est. completion date: December 5, 2020
• Est. primary completion date: November 5, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Device:
• 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.

Locations

Country	Name	City	State
China	Shanghai Chest Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Jiayuan Sun

Country where clinical trial is conducted

China, 

References & Publications (9)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success rate of the localization procedure	Calculated as follows: (number of successful targeting procedures/number of all localization procedures)*100	On the 1 day of localization operation
Primary	Success rate of the effective localization	Calculated as follows: [(number of successful targeting procedures-number of dislodgements or unrecognized in the operative field)/number of all localization procedures]*100	On the 1 day of VATS operation
Primary	Success rate of VATS sublobar resection	Calculated as follows: (number of successful VATS procedures/number of all localization procedures)*100	On the 1 day of VATS completion
Secondary	Safety endpoint	Complication rate of two localization methods, including pneumothorax, hemorrhage, etc.	On the 1 day of VATS operation
Secondary	Localization time	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.	On the 1 day of localization operation
Secondary	Operation time of VATS sublobar resection	The operation time is defined as the time from the start of the skin incision to the completion of the suture of the skin.	On the 1 day of VATS completion