Dataset Information

Randomized clinical trial of endobronchial ultrasound needle biopsy with and without aspiration.

ABSTRACT:

Background

Endobronchial ultrasound (EBUS)-guided transbronchial needle aspiration (EBUS-TBNA) is performed with a dedicated 22- or 21-gauge needle while suction is applied. Fine-needle sampling without suction (capillary sampling) has been studied for endoscopic ultrasound and for biopsies at various body sites and has resulted in similar diagnostic yield and fewer traumatic samples. However, the role of EBUS-guided transbronchial needle capillary sampling (EBUS-TBNCS) is still to be determined.

Methods

Adults with suspicious hilar or mediastinal lymph nodes (LNs) were included in a single-blinded, prospective, randomized trial comparing EBUS-TBNA and EBUS-TBNCS. The primary end point was the concordance rate between the two techniques in terms of adequacy and diagnosis of cytologic samples. The secondary end point was the concordance rate between the two techniques in terms of quality of samples.

Results

A total of 115 patients and 192 LNs were studied. Concordance between EBUS-TBNA and EBUS-TBNCS was high, with no significant difference in adequacy (88% vs 88%, respectively [P ± .858]; concordance rate, 83.9% [95% CI, 77.9-88.8]); diagnosis (36% vs 34%, respectively [P ± .289]; concordance rate, 95.8% [95% CI, 92-92.8]); diagnosis of malignancy (28% vs 26%, respectively [P ± .125]; concordance rate, 97.9% [95% CI, 94.8-99.4]); or sample quality (concordance rate, 83.3% [95% CI, 73.3-88.3]). Concordance between EBUS-TBNA and EBUS-TBNCS was high irrespective of LN size (≤ 1 cm vs > 1 cm).

Conclusions

Regardless of LN size, no differences in adequacy, diagnosis, or quality were found between samples obtained using EBUS-TBNA and those obtained using EBUS-TBNCS. There is no evidence of any benefit derived from the practice of applying suction to EBUS-guided biopsies.

Trial registry

ClinicalTrials.gov; No.: NCT00886847; URL: www.clinicaltrials.gov

SUBMITTER: Casal RF

PROVIDER: S-EPMC3610596 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundGuidelines for flexible bronchoscopy in adults recommend both Cricothyroid and Spray-as-you-go method as the acceptable techniques for lignocaine administration. No studies have compared these two methods for topical anesthesia during endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA).ObjectivesCo-primary outcomes were the comparison of cough count and operator-rated overall procedure satisfaction on a Visual Analog Scale (VAS) between the groups. The secondary outcomes were cumulative lignocaine dose, time from bronchoscope introduction to crossing the vocal cords, procedure duration, and complications between the groups.MethodsConsecutive participants (age >18 years) undergoing EBUS-TBNA were randomized (1:1) to either cricothyroid or spray-as-you-go methods for lignocaine administration.ResultsThree hundred and sixty-five participants were randomized (183: Cricothyroid and 182: Spray-as-you-go). Cough count till reaching carina (median [interquartile range]) was significantly lower (cricothyroid, 1 [0-2] vs. spray-as-you-go, 4 [2-6], P < 0.001) and operator rated overall procedure satisfaction, on VAS (mean ± standard deviation) (cricothyroid, 7.96 ± 1.48 vs. spray-as-you-go, 7.29 ± 1.48, P < 0.001) significantly greater in the cricothyroid group. Cumulative lignocaine dose (163.28 ± 31.50 mg vs. 177.0 ± 30.12 mg, P < 0.0001) and time from bronchoscope introduction to crossing the vocal cords (20.80 ± 11.21 s vs. 38.08 ± 15.26 s, P < 0.001) was significantly lower in the cricothyroid group. Procedure duration was similar in both the groups. Minor complications occurred in three patients in cricothyroid and six patients in the spray-as-you-go group (P = 0.31).ConclusionsCricothyroid lignocaine administration is associated with less cough and superior operator-rated procedure satisfaction during EBUS-TBNA, at a lower cumulative lignocaine dose administered.Trial registrationwww.clinicaltrials.gov NCT02981264.