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

November 29, 2019 updated by: Jiayuan Sun

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

188

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Jiayuan Sun, PhD
  • Phone Number: 1511 +86-021-22200000
  • Email: jysun1976@163.com

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200030
        • Recruiting
        • Shanghai Chest Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
On the 1 day of localization operation
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
On the 1 day of VATS operation
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
On the 1 day of VATS completion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety endpoint
Time Frame: On the 1 day of VATS operation
Complication rate of two localization methods, including pneumothorax, hemorrhage, etc.
On the 1 day of VATS operation
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.
On the 1 day of localization operation
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.
On the 1 day of VATS completion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jiayuan Sun

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 5, 2019

Primary Completion (Anticipated)

November 5, 2020

Study Completion (Anticipated)

December 5, 2020

Study Registration Dates

First Submitted

November 26, 2019

First Submitted That Met QC Criteria

November 29, 2019

First Posted (Actual)

December 2, 2019

Study Record Updates

Last Update Posted (Actual)

December 2, 2019

Last Update Submitted That Met QC Criteria

November 29, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHCHE201905

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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