Application of Three-Dimensionally Printed Navigational Template in Lung Biopsy
1 other identifier
interventional
150
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2020
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 25, 2020
CompletedFirst Submitted
Initial submission to the registry
February 23, 2021
CompletedFirst Posted
Study publicly available on registry
March 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2023
CompletedMarch 1, 2021
February 1, 2021
2.1 years
February 23, 2021
February 26, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Three to four working days post-biopsy were needed to establish the diagnosis of the cytological specimens acquired by fine-needle aspiration.
Secondary Outcomes (4)
Diagnostic sensitivity of percutaneous transthoracic fine-needle aspiration
If an eventual diagnosis was attained by means of follow-up, a 12-month assessment was needed.
Procedural duration
15 mins post biopsy
Radiation exposure
15 mins post biopsy
Complication rate
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.
Study Arms (2)
CT-guided lung biopsy
OTHERParticipants in this arm received conventional CT-guided percutaneous transthoracic lung biopsy.
Template-guided lung biopsy
EXPERIMENTALThree-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.
Interventions
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).
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).
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, 200433, China
Related Publications (2)
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.
PMID: 29017792BACKGROUNDZhang 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: 30586136BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Chang Chen, MD, PhD
Shanghai Pulmonary Hospital, Tongji University School of Medicine
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof. Dr.
Study Record Dates
First Submitted
February 23, 2021
First Posted
March 1, 2021
Study Start
November 25, 2020
Primary Completion
December 31, 2022
Study Completion
December 31, 2023
Last Updated
March 1, 2021
Record last verified: 2021-02
Data Sharing
- IPD Sharing
- Will not share