Back to resultsBronchoscopic ICG Injection and Percutaneous Hook-wire Techniques for Preoperative Lung Nodule Localization in VATS
Primary Purpose
Lung Cancer
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Indocyanine green (ICG)
Electromagnetic navigation bronchoscopy
Hook wire
Sponsored by
About this trial
This is an interventional supportive care trial for Lung Cancer focused on measuring Electromagnetic navigation bronchoscopy (ENB), localization, Lung cancer, Video-associated thoracic surgery, Indocyanine green (ICG)
Eligibility Criteria
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.
Sites / Locations
- Shanghai Chest HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Bronchoscopic ICG localization
percutaneous hook-wire localization
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Success rate of the localization procedure
Calculated as follows: (number of successful targeting procedures/number of all localization procedures)*100
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
Success rate of VATS sublobar resection
Calculated as follows: (number of successful VATS procedures/number of all localization procedures)*100
Secondary Outcome Measures
Safety endpoint
Complication rate of two localization methods, including pneumothorax, hemorrhage, etc.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04182152
Brief Title
Bronchoscopic ICG Injection and Percutaneous Hook-wire Techniques for Preoperative Lung Nodule Localization in VATS
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Unknown status
Study Start Date
November 5, 2019 (Actual)
Primary Completion Date
November 5, 2020 (Anticipated)
Study Completion Date
December 5, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jiayuan Sun
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
Electromagnetic navigation bronchoscopy (ENB), localization, Lung cancer, Video-associated thoracic surgery, Indocyanine green (ICG)
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
188 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Bronchoscopic ICG localization
Arm Type
Experimental
Arm Description
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.
Arm Title
percutaneous hook-wire localization
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Indocyanine green (ICG)
Intervention Description
Indocyanine green (ICG) was diluted with saline to 0.5mg/mL, and injected 0.6mL/site.
Intervention Type
Device
Intervention Name(s)
Electromagnetic navigation bronchoscopy
Intervention Description
Electromagnetic navigation bronchoscopy (ENB) allows physicians to access peripheral lung nodules with high accuracy and provides a working channel for ICG injection.
Intervention Type
Device
Intervention Name(s)
Hook wire
Intervention Description
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.
Primary Outcome Measure Information:
Title
Success rate of the localization procedure
Description
Calculated as follows: (number of successful targeting procedures/number of all localization procedures)*100
Time Frame
On the 1 day of localization operation
Title
Success rate of the effective localization
Description
Calculated as follows: [(number of successful targeting procedures-number of dislodgements or unrecognized in the operative field)/number of all localization procedures]*100
Time Frame
On the 1 day of VATS operation
Title
Success rate of VATS sublobar resection
Description
Calculated as follows: (number of successful VATS procedures/number of all localization procedures)*100
Time Frame
On the 1 day of VATS completion
Secondary Outcome Measure Information:
Title
Safety endpoint
Description
Complication rate of two localization methods, including pneumothorax, hemorrhage, etc.
Time Frame
On the 1 day of VATS operation
Title
Localization time
Description
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.
Time Frame
On the 1 day of localization operation
Title
Operation time of VATS sublobar resection
Description
The operation time is defined as the time from the start of the skin incision to the completion of the suture of the skin.
Time Frame
On the 1 day of VATS completion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jiayuan Sun, PhD
Phone
+86-021-22200000
Ext
1511
Email
jysun1976@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jiayuan Sun, MD
Organizational Affiliation
Shanghai Chest Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai Chest Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200030
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jiayuan Sun, PhD
Phone
+86-021-22200000
Ext
1511
Email
jysun1976@163.com
12. IPD Sharing Statement
Citations:
PubMed Identifier
28343689
Citation
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Citation
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Bronchoscopic ICG Injection and Percutaneous Hook-wire Techniques for Preoperative Lung Nodule Localization in VATS
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