Back to resultsApplication of Three-Dimensionally Printed Navigational Template in Lung Biopsy
Primary Purpose
Lung Neoplasms
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
CT-guided lung biopsy
Template-guided lung biopsy
Sponsored by
About this trial
This is an interventional diagnostic trial for Lung Neoplasms focused on measuring Biopsy, Needle, Printing, Three-Dimensional, Image-Guided Biopsy
Eligibility Criteria
Ⅰ. Inclusion Criteria:
A. CT confirmed peripheral lung lesion;
B. Nodule size larger than or equal to 30 mm;
C. Scheduled for percutaneous transthoracic fine-needle aspiration;
D. Percutaneous transthoracic lung biopsy was conducted at supine or partially lateral decubitus;
E. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2;
F. Written informed consent provided.
Ⅱ. Exclusion Criteria:
A. Biopsy needle insertion route impeded by skeletal structures;
B. Lesion within 3 cm above diaphragmatic dome;
C. Insertion route longer than the biopsy needle;
D. Lung biopsy needed to be conducted at vertically lateral decubitus;
E. Any contraindication of percutaneous transthoracic lung biopsy;
F. Women who are pregnant or in the period of breastfeeding.
Sites / Locations
- Shanghai Pulmonary HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Experimental
Arm Label
CT-guided lung biopsy
Template-guided lung biopsy
Arm Description
Participants in this arm received conventional CT-guided percutaneous transthoracic lung biopsy.
Three-dimensionally printed navigational template was designed based on the CT scan images acquired before the biopsy. Under the guidance of navigational template, percutaneous transthoracic lung biopsy was conducted.
Outcomes
Primary Outcome Measures
Diagnostic yield of percutaneous transthoracic fine-needle aspiration
A percutaneous transthoracic fine-needle aspiration procedure was considered diagnostic if a malignant or specific benign diagnosis of the lesion was made. The ratio of diagnostic cases to all the participants who received the corresponding biopsy was considered as diagnostic yield.
Secondary Outcome Measures
Diagnostic sensitivity of percutaneous transthoracic fine-needle aspiration
All biopsy results that showed lung cancer were considered true positives (TP). For participants who had a nondiagnostic (intermediate or indeterminate) result from the first lung biopsy (fine-needle aspiration), subsequent diagnostic modalities including a re-biopsy, transbronchial needle aspiration or a 12-month follow-up was conducted to determine the final diagnosis. If any of these modalities demonstrated malignant, the case was considered a false negative (FN). Diagnostic sensitivity of the fine-needle aspiration procedure for lung cancer was defined as TP / (TP + FN).
Procedural duration
The length of procedural duration was measured from the time a patient lain on the examining bed of the CT scanner to the time the first CT scan post fine-needle biopsy was conducted.
Radiation exposure
The dosage of the radiation exposure the participant received during the process of fine-needle aspiration.
Complication rate
Complication post fine-needle aspiration was evaluated by the first CT scan images post biopsy. Common complications include pneumothorax, pulmonary hemorrhage and hemoptysis. Complications needed further interventions were specially recorded.
Full Information
NCT ID
NCT04775901
First Posted
February 23, 2021
Last Updated
February 26, 2021
Sponsor
Shanghai Pulmonary Hospital, Shanghai, China
1. Study Identification
Unique Protocol Identification Number
NCT04775901
Brief Title
Application of Three-Dimensionally Printed Navigational Template in Lung Biopsy
Official Title
Application of Three-Dimensionally Printed Navigational Template in Percutaneous Transthoracic Lung Biopsy: A Prospective, Randomized, Controlled, Noninferiority Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Recruiting
Study Start Date
November 25, 2020 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Pulmonary Hospital, Shanghai, China
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a prospective, randomized, controlled study to evaluate the diagnostic yield and safety of three-dimensionally printed navigational template in percutaneous transthoracic lung biopsy.
Detailed Description
The feasibility of three-dimensionally printed navigational template-guided percutaneous transthoracic fine-needle aspiration was validated by a phase I study. To further investigate the non-inferiority of navigational template-guided lung biopsy to conventional CT-guided modality in terms of diagnostic yield, this prospective, randomized, controlled, noninferiority trial was conducted.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Neoplasms
Keywords
Biopsy, Needle, Printing, Three-Dimensional, Image-Guided Biopsy
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CT-guided lung biopsy
Arm Type
Other
Arm Description
Participants in this arm received conventional CT-guided percutaneous transthoracic lung biopsy.
Arm Title
Template-guided lung biopsy
Arm Type
Experimental
Arm Description
Three-dimensionally printed navigational template was designed based on the CT scan images acquired before the biopsy. Under the guidance of navigational template, percutaneous transthoracic lung biopsy was conducted.
Intervention Type
Other
Intervention Name(s)
CT-guided lung biopsy
Intervention Description
Percutaneous transthoracic lung biopsy was conducted stepwise under the real-time guidance of CT scan. This kind of modality served as an effective method for diagnosing peripheral lung lesions (all of the participants received fine-needle aspiration, some of them received coaxial needle biopsy as well, according to the pulmonologist's instruction).
Intervention Type
Device
Intervention Name(s)
Template-guided lung biopsy
Intervention Description
A three-dimensional model consisting of participant's thoracic image information was initially reconstructed based on the CT scan data. Afterwards, a navigational template was customized, which accommodated well to the anatomical landmarks of the participant. The template was then printed by means of stereolithography from photopolymer material. Participants would receive navigational template-guided percutaneous transthoracic lung biopsy (all of the participants received fine-needle aspiration, some of them received coaxial needle biopsy as well, according to the pulmonologist's instruction).
Primary Outcome Measure Information:
Title
Diagnostic yield of percutaneous transthoracic fine-needle aspiration
Description
A percutaneous transthoracic fine-needle aspiration procedure was considered diagnostic if a malignant or specific benign diagnosis of the lesion was made. The ratio of diagnostic cases to all the participants who received the corresponding biopsy was considered as diagnostic yield.
Time Frame
Three to four working days post-biopsy were needed to establish the diagnosis of the cytological specimens acquired by fine-needle aspiration.
Secondary Outcome Measure Information:
Title
Diagnostic sensitivity of percutaneous transthoracic fine-needle aspiration
Description
All biopsy results that showed lung cancer were considered true positives (TP). For participants who had a nondiagnostic (intermediate or indeterminate) result from the first lung biopsy (fine-needle aspiration), subsequent diagnostic modalities including a re-biopsy, transbronchial needle aspiration or a 12-month follow-up was conducted to determine the final diagnosis. If any of these modalities demonstrated malignant, the case was considered a false negative (FN). Diagnostic sensitivity of the fine-needle aspiration procedure for lung cancer was defined as TP / (TP + FN).
Time Frame
If an eventual diagnosis was attained by means of follow-up, a 12-month assessment was needed.
Title
Procedural duration
Description
The length of procedural duration was measured from the time a patient lain on the examining bed of the CT scanner to the time the first CT scan post fine-needle biopsy was conducted.
Time Frame
15 mins post biopsy
Title
Radiation exposure
Description
The dosage of the radiation exposure the participant received during the process of fine-needle aspiration.
Time Frame
15 mins post biopsy
Title
Complication rate
Description
Complication post fine-needle aspiration was evaluated by the first CT scan images post biopsy. Common complications include pneumothorax, pulmonary hemorrhage and hemoptysis. Complications needed further interventions were specially recorded.
Time Frame
Real-time complication post biopsy indicates those recognized by the immediate CT scan, while delayed complication indicates those recognized by radiograph taken 4-6 hours post biopsy.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Ⅰ. Inclusion Criteria:
A. CT confirmed peripheral lung lesion;
B. Nodule size larger than or equal to 30 mm;
C. Scheduled for percutaneous transthoracic fine-needle aspiration;
D. Percutaneous transthoracic lung biopsy was conducted at supine or partially lateral decubitus;
E. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2;
F. Written informed consent provided.
Ⅱ. Exclusion Criteria:
A. Biopsy needle insertion route impeded by skeletal structures;
B. Lesion within 3 cm above diaphragmatic dome;
C. Insertion route longer than the biopsy needle;
D. Lung biopsy needed to be conducted at vertically lateral decubitus;
E. Any contraindication of percutaneous transthoracic lung biopsy;
F. Women who are pregnant or in the period of breastfeeding.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Haoran E, MD
Phone
+86-021-19916946180
Email
ehaoran@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Chang Chen, MD, PhD
Phone
+86-021-65115006
Ext
2074
Email
chenthoracic@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chang Chen, MD, PhD
Organizational Affiliation
Shanghai Pulmonary Hospital, Tongji University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai Pulmonary Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200433
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chang Chen, MD,PhD
Phone
+86-021-65115006
Ext
2074
Email
chenthoracic@163.com
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
29017792
Citation
Zhang L, Li M, Li Z, Kedeer X, Wang L, Fan Z, Chen C. Three-dimensional printing of navigational template in localization of pulmonary nodule: A pilot study. J Thorac Cardiovasc Surg. 2017 Dec;154(6):2113-2119.e7. doi: 10.1016/j.jtcvs.2017.08.065. Epub 2017 Sep 1.
Results Reference
background
PubMed Identifier
30586136
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.
Results Reference
background
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Application of Three-Dimensionally Printed Navigational Template in Lung Biopsy
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