Clinical trial · Interventional

Conventional vs Ultrathin Bronchoscopy for Peripheral Pulmonary Lesions

Conventional vs Ultrathin Bronchoscopy With Transbronchial Needle Aspiration for the Diagnosis of Peripheral Pulmonary Lesions: a Randomized Controlled Trial

NCT04029155CI-TRIAL-00058744unknownN/AClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

This study's purpose is to evaluate whether the use of an ultra-thin bronchoscope can improve sensitivity and diagnostic yield in peripheral pulmonary nodules. The ultra-thin probe is expected to reach further bronchi and allow to reach peripheral lesions. Moreover, the ability to identify molecular pattern of lung cancer is essential nowadays, and it will be therefore evaluated.

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Lung Cancer	Malignant Lung Neoplasm	CURATED_EXACT	0.92

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
Lung biopsy	Device	—	UNRESOLVED

Design

Arms and outcomes

Arms (2)

type
ACTIVE_COMPARATOR
label
TBNA with Conventional bronchoscope
description
patients in this arm will undergo bronchoscopy by a conventional probe
interventionNames
1. Device: Lung biopsy
type
EXPERIMENTAL
label
TBNA with a Ultrathin bronchoscope
description
Patients in this arm will undergo bronchoscopy by a ultra thin probe
interventionNames
1. Device: Lung biopsy

Primary outcomes (1)

measure
Assess if sensitivity is higher in the "ultrathin" arm than in the "conventional" arm
timeFrame
through study completion, an average of 6 months

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years

Show eligibility criteria text

Inclusion Criteria:

* age ≥ 18years;
* presence of at least one peripheral pulmonary lesion ≤ 3 cm on CT scan;
* ability to give an informed consent.

Exclusion Criteria:

* coagulopathy or bleeding diathesis that cannot be corrected;
* severe refractory hypoxemia;
* unstable hemodynamic status;
* inability to give an informed consent.

References

Publications (13)

BACKGROUNDHaponik EF, Shure D. Underutilization of transbronchial needle aspiration: experiences of current pulmonary fellows. Chest. 1997 Jul;112(1):251-3. doi: 10.1378/chest.112.1.251. PMID 9228384
BACKGROUNDHarrow EM, Abi-Saleh W, Blum J, Harkin T, Gasparini S, Addrizzo-Harris DJ, Arroliga AC, Wight G, Mehta AC. The utility of transbronchial needle aspiration in the staging of bronchogenic carcinoma. Am J Respir Crit Care Med. 2000 Feb;161(2 Pt 1):601-7. doi: 10.1164/ajrccm.161.2.9902040. PMID 10673206
BACKGROUNDGasparini S, Silvestri GA. Usefulness of transbronchial needle aspiration in evaluating patients with lung cancer. Thorax. 2005 Nov;60(11):890-1. doi: 10.1136/thx.2005.048728. No abstract available. PMID 16263944
BACKGROUNDPatelli M, Lazzari Agli L, Poletti V, Trisolini R, Cancellieri A, Lacava N, Falcone F, Boaron M. Role of fiberscopic transbronchial needle aspiration in the staging of N2 disease due to non-small cell lung cancer. Ann Thorac Surg. 2002 Feb;73(2):407-11. doi: 10.1016/s0003-4975(01)03447-6. PMID 11845850
BACKGROUNDTrisolini R, Tinelli C, Cancellieri A, Paioli D, Alifano M, Boaron M, Patelli M. Transbronchial needle aspiration in sarcoidosis: yield and predictors of a positive aspirate. J Thorac Cardiovasc Surg. 2008 Apr;135(4):837-42. doi: 10.1016/j.jtcvs.2007.11.011. PMID 18374764
BACKGROUNDIyoda A, Baba M, Shibuya K, Moriya Y, Yasufuku K, Sekine Y, Iizasa T, Hiroshima K, Nakatani Y, Fujisawa T. Transbronchial fine needle aspiration cytological examination: a useful tool for diagnosing primary lung cancer. Thorac Cardiovasc Surg. 2006 Mar;54(2):117-9. doi: 10.1055/s-2005-865924. PMID 16541353
BACKGROUNDRoth K, Hardie JA, Andreassen AH, Leh F, Eagan TM. Predictors of diagnostic yield in bronchoscopy: a retrospective cohort study comparing different combinations of sampling techniques. BMC Pulm Med. 2008 Jan 26;8:2. doi: 10.1186/1471-2466-8-2.