Trial of Endobronchial Ultrasound Guided Fine Needle Aspiration Techniques

NCT01741571 | Completed

• 1 other identifier: AmericanUBMC
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

Endobronchial ultrasound-guided transbronchial fine needle aspiration (EBUS-TBNA) techniques have not been well studied. The investigators will conduct a randomized study comparing the diagnostic yield and specimen quality of EBUS-FNA performed with and without suction applied.

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (2)

• Sensitivity of each needle aspiration technique for diagnosis of malignancy

  A pathologist blinded to the needle aspiration technique will review the specimen obtained from each needle aspiration and will assess for presence of malignant cells. The sensitivity for diagnosing malignancy will be calculated and compared for the two needle aspiration technique.

  Diagnosis of malignancy will be ascertained after 6 month clinical follow up

• Diagnostic accuracy of each needle aspiration technique for diagnosis of malignancy

  A pathologist blinded to the needle aspiration technique will review the specimen obtained from each needle aspiration and will assess for presence of malignant cells. The diagnostic accuracy for diagnosing malignancy will be assessed and compared for the two needle aspiration technique.

  Diagnosis of malignancy will be ascertained after 6 month clinical follow up

Secondary Outcomes (4)

• Adequacy of the needle aspiration sample

  Adequacy will be assessed within 1 week from procedure

• Negative predicted value of each needle aspiration technique for diagnosis of malignancy

  Diagnosis of malignancy will be ascertained after 6 month of clinical follow up

• Specificity of each needle aspiration technique for diagnosis of malignancy

  Diagnosis of malignancy will be ascertained after 6 month clinical follow up

• Positive predicted value of each needle aspiration technique for diagnosis of malignancy

  Diagnosis of Malignancy will be ascertained after 6 month of clinical follow up

Study Arms (2)

EBUS guided FNA with suction

ACTIVE COMPARATOR

Device/procedure: lymph node tissue collection using fine needle aspiration with suction applied. Four fine needle aspirations will be taken sequentially from each lymph node. Two with suction and two without suction applied.

Device: EBUS guided FNA with and without suction

EBUS guided FNA without suction

EXPERIMENTAL

Device/procedure: lymph node tissue collection using fine needle aspiration without suction applied. Four fine needle aspirations will be taken sequentially from each lymph node. Two with suction and two without suction applied.

Device: EBUS guided FNA with and without suction

Interventions

EBUS guided FNA with and without suction DEVICE

Device/procedure: lymph node tissue collection using needle with and without suction applied. Four fine needle aspirations will be taken from each lymph node. Two with suction and two without suction applied.

EBUS guided FNA with suction; EBUS guided FNA without suction

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult undergoing EBUS at AUBMC for suspected malignancy

You may not qualify if:

• Coagulopathy
• The lesion cannot be sampled because of intervening tumor or blood vessels.

Sponsors & Collaborators

• American University of Beirut Medical Center: lead

Study Sites (1)

American University of Beirut

Beirut, Lebanon

Location

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Suction

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Drainage; Surgical Procedures, Operative

Study Officials

• Hassan Chami, MD

  American University of Beirut Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 27, 2012
• First Posted: December 5, 2012
• Study Start: December 1, 2012
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2017
• Last Updated: September 21, 2020

Record last verified: 2020-09

Locations

LE (1)