N/A N=86 Randomized Diagnostic

ENB-GS-TBLB for the Diagnosis of PPLs

Lung Cancer

Bottom Line

View on ClinicalTrials.gov: NCT02207478 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2015

Primary outcome: Primary: The Difference of Diagnostic Value of ENB-GS-TBLB as Compared to GS-TBLB — 34; 25; 5; 16 participants — p=0.019

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: ENB (Procedure); GS-TBLB-X-ray (Procedure)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Shanghai Chest Hospital
Primary completion: Mar 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY The Difference of Diagnostic Value of ENB-GS-TBLB as Compared to GS-TBLB	34; 25; 5; 16	0.019 sig
SECONDARY The Duration Time Difference of ENB-GS-TBLB With Fluoroscopy as Compared to GS-TBLB With Fluoroscopy Alone	1053.6; 1056.6; 156.56; 142.27; 126.74; 224.98	0.843

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) .

Eligibility Criteria

Inclusion Criteria

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.

Exclusion Criteria

The lesion is close to the pleural membrane
Refusal of participation
Severe cardiopulmonary dysfunction and other indications that can't receive bronchoscopy

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02207478). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.