NCT03488043

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 26, 2018

Completed
6 days until next milestone

Study Start

First participant enrolled

April 1, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 4, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2019

Completed
Last Updated

July 27, 2018

Status Verified

March 1, 2018

Enrollment Period

1 year

First QC Date

March 26, 2018

Last Update Submit

July 26, 2018

Conditions

Pneumothorax

Keywords

Lung lesionsPneumothoraxCT-guided transthoracic biopsyRisk score

Outcome Measures

Primary Outcomes (1)

  • Pneumothorax occurrence

    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

Study Arms (2)

Retrospective cohort

All patients having a CT-guided transthoracic biopsy from September 2012 and September 2017.

Procedure: Needle lung biopsy

Prospective cohort

All patients having a CT-guided transthoracic biopsy from April 2018.

Procedure: Needle lung biopsy

Interventions

Needle lung biopsyPROCEDURE

Needle lung biopsy

Prospective cohortRetrospective cohort

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

See eligibilty criteria

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Besançon

Besançon, Doubs, 25000, France

RECRUITING

Related Publications (1)

  • Lamfichekh Y, Lafay V, Hamam J, Guillien A, Puyraveau M, Behr J, Manzoni P, Calame P, Dalphin JC, Eberst G, Grillet F, Westeel V. Score to Predict the Occurrence of Pneumothorax After Computed Tomography-guided Percutaneous Transthoracic Lung Biopsy. J Thorac Imaging. 2023 Sep 1;38(5):315-324. doi: 10.1097/RTI.0000000000000729. Epub 2023 Jul 17.

    PMID: 37603106DERIVED

MeSH Terms

Conditions

Pneumothorax

Condition Hierarchy (Ancestors)

Pleural DiseasesRespiratory Tract Diseases

Central Study Contacts

Joffrey Hamam

CONTACT

0381668802joffrey.hamam@live.fr

Jean-Charles Dalphin

CONTACT

0381668802jean-charles.dalphin@univ-fcomte.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 26, 2018

First Posted

April 4, 2018

Study Start

April 1, 2018

Primary Completion

April 1, 2019

Study Completion

April 1, 2019

Last Updated

July 27, 2018

Record last verified: 2018-03

Locations

FR(1)