Predictive Score of PneumOThorax Secondary to CT-guided Transthoracic Lung Biopsy Made From a Large Retrospective Cohort and Validated on a Prospective Cohort (SPOT)

July 26, 2018 updated by: Centre Hospitalier Universitaire de Besancon
Transthoracic lung biopsy (TLB) provides a histological diagnosis of nodule or lung mass. Pneumothorax is the main complication of TLB with an average of 20%. Many risk factors, whether clinical, computed tomography or related to TLB, are described in the literature. The British Thoracic Society recommends monitoring for 2 hours after the procedure with a possible discharge if the chest X-ray is normal. There is no French or European recommendation for monitoring the occurrence of pneumothorax after TLB. In the university center of Besançon, France, a minimum supervision of 4 hours is recommended and approximately one in two patients is hospitalized until the following day to reach this minimum time of 4 hours. The objective of the SPOT study is to perform a predictive score of pneumothorax from a retrospective cohort of patients for whom a transthoracic lung biopsy was performed and to validate this score on a prospective cohort. The expected goal is to select patients who can benefit from outpatient care by shortening the post-procedure surveillance period and to monitor more long-term only high-risk patients.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

See eligibilty criteria

Description

Inclusion Criteria:

  • Patients having needle lung biopsy CT-guided for diagnostic purposes.

Exclusion Criteria:

  • Nodule or mass in contact with the pleura for which the aerated pulmonary parenchyma is not crossed by the puncture needle.
  • Several pulmonary sites biopsied.
  • Existence of a pneumothorax before procedure
  • Per-procedural appearance of alveolar or interstitial pneumonitis at the level of the biopsy area.
  • Cavitary aspect of nodule or mass
  • Absence of chest X-ray control
  • Poorness quality of chest X-ray control

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Retrospective cohort
All patients having a CT-guided transthoracic biopsy from September 2012 and September 2017.
Procedure: Needle lung biopsy
Needle lung biopsy
Prospective cohort
All patients having a CT-guided transthoracic biopsy from April 2018.
Procedure: Needle lung biopsy
Needle lung biopsy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pneumothorax occurrence
Time Frame: between 4 and 24 hours after procedure
Pneumothorax is defined by the observation on the chest x-ray of a pleural detachment regardless of its importance.
between 4 and 24 hours after procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Besancon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2018

Primary Completion (Anticipated)

April 1, 2019

Study Completion (Anticipated)

April 1, 2019

Study Registration Dates

First Submitted

March 26, 2018

First Submitted That Met QC Criteria

April 3, 2018

First Posted (Actual)

April 4, 2018

Study Record Updates

Last Update Posted (Actual)

July 27, 2018

Last Update Submitted That Met QC Criteria

July 26, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P/2018/372

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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