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

NCT04182152 | Unknown

• 1 other identifier: SHCHE201905
• Study Type: interventional
• Target: 188
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lung Cancer

Keywords

Electromagnetic navigation bronchoscopy (ENB); localization; Lung cancer; Video-associated thoracic surgery; Indocyanine green (ICG)

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (3)

• Safety endpoint

  On the 1 day of VATS operation

• Localization time

  On the 1 day of localization operation

• Operation time of VATS sublobar resection

  On the 1 day of VATS completion

Study Arms (2)

Bronchoscopic ICG localization

EXPERIMENTAL

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.

Device: Indocyanine green (ICG); Device: Electromagnetic navigation bronchoscopy

percutaneous hook-wire localization

ACTIVE COMPARATOR

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.

Device: Hook wire

Interventions

Indocyanine green (ICG) DEVICE

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

Bronchoscopic ICG localization

Electromagnetic navigation bronchoscopy DEVICE

Electromagnetic navigation bronchoscopy (ENB) allows physicians to access peripheral lung nodules with high accuracy and provides a working channel for ICG injection.

Bronchoscopic ICG localization

Hook wire DEVICE

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.

percutaneous hook-wire localization

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jiayuan Sun: lead

Study Sites (1)

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, 200030, China

RECRUITING

Related Publications (9)

• 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.

  PMID: 28343689 BACKGROUND

• 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.

  PMID: 27717643 BACKGROUND

• 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.

  PMID: 30586136 BACKGROUND

• 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.

  PMID: 26793384 BACKGROUND

• 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.

  PMID: 22361249 BACKGROUND

• 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.

  PMID: 25442988 BACKGROUND

• 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.

  PMID: 28314525 BACKGROUND

• 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.

  PMID: 30882669 BACKGROUND

• 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.

  PMID: 29329549 BACKGROUND

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Jiayuan Sun, MD

  Shanghai Chest Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiayuan Sun, PhD

CONTACT

+86-021-22200000; jysun1976@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director, Department of Endoscopy, Shanghai Chest Hospital

Study Record Dates

• First Submitted: November 26, 2019
• First Posted: December 2, 2019
• Study Start: November 5, 2019
• Primary Completion: November 5, 2020
• Study Completion: December 5, 2020
• Last Updated: December 2, 2019

Record last verified: 2019-11

Locations

CN (1)