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Completed

NCT Number: NCT02813603

Comparison of 22-gauge and 19-gauge Aspiration Needle During EBUS-TBNA

Investigators intend to compare the 19-gauge needle and the 22-gauge-needle during EBUS-TBNA concerning the diagnostic yield, the quality and quantity of each biopsy needle without raising the rate of complications.

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Key information

Conditions

Lung Cancer Lung Diseases Lung Neoplasms Lymphatic Metastasis Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ruhrlandklinik, University Hospital Essen, Essen, North Rhine-Westphalia, Germany

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About this study

Investigators intend to compare the 19-gauge needle and the 22-gauge-needle during EBUS-TBNA performed in rigid bronchoscopy for patients with probable lung cancer diagnosis and enlarged mediastinal lymph nodes.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female patients aged over 18
  • Patients signed written informed consent
  • Mediastinal or hilar enlarged lymph nodes (>10mm) in short axis radiological or clinical findings likely for lung cancer

Exclusion criteria

  • Severe impairment of any organs, with do not enable anaesthesia
  • Quick <80%, INR >1,5, thrombocytes <50/nl or PTT>120sec
  • Other clinically relevant medical or psychological diseases, which affect the patients judgement or ability to participate in this study.
  • Insufficient language ability (spoken and written German)

Treatment and study plan

EBUS

Procedure

19G and 22G EBUS needles are compared in a randomized prospective way in lung cancer patients with enlarged mediastinal lymph nodes.

Primary outcomes

  1. sample weight

    Time frame: February 2017

Secondary outcomes

  1. The number of complications like bleeding, infections, pneumothorax and pain

    Time frame: February 2017

Sponsors and collaborators

Lead sponsor

University Hospital, Essen

Other

Collaborators

  • University Hospital, Zürich

Registry information

Official study title

Comparison of the Diagnostic Yield Between Various Endobronchial Ultrasound-guided-transbronchial Needles (EBUS-TBN) to Evaluate Suspect Mediastinal and Hilar Lymph Nodes

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jun 27, 2016
Registry last updated
Jul 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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