ENB-GS-TBLB for the Diagnosis of PPLs
Diagnostic Value of Electromagnetic Navigation Bronchoscopy With a Guide Sheath for Peripheral Pulmonary Lesions : a Randomized Controlled Trial
1 other identifier
interventional
80
1 country
1
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of electromagnetic navigation bronchoscopy with a Guide Sheath(ENB-GS) for the diagnosis of peripheral pulmonary lesions (PPLs) .
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable lung-cancer
Started Jul 2014
Shorter than P25 for not_applicable lung-cancer
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
July 1, 2014
CompletedFirst Submitted
Initial submission to the registry
August 1, 2014
CompletedFirst Posted
Study publicly available on registry
August 4, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2015
CompletedResults Posted
Study results publicly available
November 30, 2015
CompletedNovember 30, 2015
October 1, 2015
8 months
August 1, 2014
September 23, 2015
October 28, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The Difference of Diagnostic Value of ENB-GS-TBLB as Compared to GS-TBLB
The diagnostic yield in the ENB-GS-TBLB and GS-TBLB group was 87.2% and 61% individually.
Up to half year
Secondary Outcomes (1)
The Duration Time Difference of ENB-GS-TBLB With Fluoroscopy as Compared to GS-TBLB With Fluoroscopy Alone
Up to half year
Study Arms (2)
ENB-GS-TBLB-X-ray Group
EXPERIMENTALThe guide sheath(GS) is introduced into the lesion via Electromagnetic Navigation System. The locatable guide(LG) and GS are confirmed to reach the lesion by radiograph fluoroscopy, pathologic specimens are obtained with fluoroscopic guidance.
GS-TBLB-X-ray group
ACTIVE COMPARATORThe GS is introduced into the lesion via the working channel of a bronchoscope with radiographic fluoroscopy. Once the location of the lesion is identified by fluoroscopy, pathologic specimens are obtained under fluoroscopic guidance.
Interventions
ENB is performed using an electromagnetic navigation system (LK-DW-NK-Z; Suzhou Lungcare Medical Technology Inc., China) with an internal locatable guide (LG; Lungcare) with diameter of 1.45 mm. Bronchoscopes with a working channel diameter of 2.0 mm are used (BF-260 and BF-P260F; Olympus, Japan). The LG is inserted into the GS(K-201; Olympus) beforehand, and the GS-covered LG is introduced via the working channel of the bronchoscope and navigated to the PPL finally. The LG and GS are confirmed to reach the lesion by radiograph fluoroscopy.
A GS is introduced in the working channel of the bronchoscope alone. The GS is confirmed to reach the lesion by radiograph fluoroscopy, pathologic specimens are obtained under fluoroscopic guidance.
Eligibility Criteria
You may qualify if:
- clinical and imaging characteristics suggestive of maligancy
- CT scan appearance of the PPLs showed the longest diameter was more than 1 cm and solid lesions.
You may not qualify if:
- The lesion is close to the pleural membrane
- Refusal of participation
- Severe cardiopulmonary dysfunction and other indications that can't receive bronchoscopy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Shanghai Chest Hospitallead
- Fudan Universitycollaborator
Study Sites (1)
Shanghai Chest Hospital
Shanghai, China
Related Publications (3)
Gex G, Pralong JA, Combescure C, Seijo L, Rochat T, Soccal PM. Diagnostic yield and safety of electromagnetic navigation bronchoscopy for lung nodules: a systematic review and meta-analysis. Respiration. 2014;87(2):165-76. doi: 10.1159/000355710. Epub 2014 Jan 3.
PMID: 24401166BACKGROUNDBaaklini WA, Reinoso MA, Gorin AB, Sharafkaneh A, Manian P. Diagnostic yield of fiberoptic bronchoscopy in evaluating solitary pulmonary nodules. Chest. 2000 Apr;117(4):1049-54. doi: 10.1378/chest.117.4.1049.
PMID: 10767238BACKGROUNDWang Memoli JS, Nietert PJ, Silvestri GA. Meta-analysis of guided bronchoscopy for the evaluation of the pulmonary nodule. Chest. 2012 Aug;142(2):385-393. doi: 10.1378/chest.11-1764.
PMID: 21980059BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Jiayuan Sun
- Organization
- Shanghai Chest hospital
Study Officials
- PRINCIPAL INVESTIGATOR
Jiayuan Sun, MD
Shanghai Chest Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
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
- Director, Endoscope Center, Shanghai Chest Hospita
Study Record Dates
First Submitted
August 1, 2014
First Posted
August 4, 2014
Study Start
July 1, 2014
Primary Completion
March 1, 2015
Study Completion
April 1, 2015
Last Updated
November 30, 2015
Results First Posted
November 30, 2015
Record last verified: 2015-10