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OpenTrials
Completed

NCT Number: NCT04621344

Complications After Endosonography and Guided Bronchoscopy

The present study aims to investigate prospectively and systematically the direct and indirect complications occurring within 30 days after guided-bronchoscopy and/or endosonography. The results of the study should reliably help clarify further incidence, pattern, risk factors, and outcomes for both immediate and late complications associated with these key diagnostic procedures.

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Key information

Conditions

Complication of Bronchoscopy Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondazione Policlinico Universitario A. Gemelli IRCCS

Rome, Lazio, 00168, Italy

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age >18 years,
  • Indication to undergo bronchoscopy, endosonography, or both.
  • Signed informed consent

Exclusion criteria

  • Absolute contraindications to the bronchoscopic examination based on international guidelines [31].
  • Platelet count <50000

Treatment and study plan

Guided bronchoscopy and/or endosonography

Diagnostic Test

Endoscopic procedures aimed at sampling of intrathoracic lymph nodes or pulmonary lesions

Primary outcomes

  1. Incidence of severe complications

    Time frame: 30 days

Secondary outcomes

  1. Overall incidence of complications

    Time frame: 30 days

  2. Risk factors associated with severe complications

    Time frame: 30 days

  3. Rate of unplanned hospital admissions

    Time frame: 30 days

  4. Mortality

    Time frame: 30 days

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

30-DAY MORBIDITY, MORTALITY AND UNPLANNED HOSPITAL ADMISSIONS AFTER GUIDED-BRONCHOSCOPY AND ENDOSONOGRAPHY

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Nov 9, 2020
Registry last updated
Apr 14, 2022

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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