Pneumothorax Iatrogenic PostproceduralKELSONCT07528170
Complications After CT-guided Lung Biopsies at St. Olavs Hospital
An observational study of Pneumothorax Iatrogenic Postprocedural and Air Embolism as A Complication of Medical Care, run by St. Olavs Hospital.
Trial summary
At St. Olavs Hospital, a prospective collection of data on complications related to CT-guided lung biopsies has been conducted over several years as part of quality control study. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pneumothorax Iatrogenic Postprocedural, Air Embolism as A Complication of Medical Care, Hemoptysis
- What is being tested?
- CT-guided needle biopsy of lung nodule
- Type of treatment
- Surgery or procedure
- How many people
- 1,200 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2012to 31 Dec 2023
- How long will I take part?
- 1200 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 1200
Who may be able to join
- All patients eligible to a CT-guided needle biopsy of a lung nodule (allcomers)
Who cannot join
- None
About this study
At St. Olavs Hospital, a prospective collection of data on complications related to CT-guided lung biopsies has been conducted over several years as part of quality control study. The primary aim of this quality control study is to map complications in all patients who have undergone percutaneous CT-guided lung biopsy at St. Olavs Hospital from May 2012 to December 2023.
- Conditions
- Pneumothorax Iatrogenic Postprocedural, Air Embolism as A Complication of Medical Care, Hemoptysis
- Being tested
- CT-guided needle biopsy of lung nodule
- Keywords
- Lung cancer, CT-guided lung biopsy
- Medical subject headings
- Hemoptysis, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT-guided needle biopsy of lung noduleProcedure or surgery
This is a simple needle biopsy of lung nodules guided with CT imaging
| Study group | Role | What they receive |
|---|---|---|
| CT-guided lung biopsy | All patient with a lung nodule eligible for CT-guided needle biopsy Receives: Procedure: CT-guided needle biopsy of lung nodule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pneumothorax
The frequency of pneumothorax after lung biopsy
Measured: Patients are assessed with a CT scan 5 minutes after the lung biopsy
Lung bleeding
How frequent is parenchymal bleeding after lung biopsy
Measured: Patiens are assessed with a CT scan 5 minutes after the procedure
Secondary outcomes (1)
Factors associated with complications after lung biopsy
Analyse possible factors leading to complications after lung biopsies
Measured: All patiens are assessed with CT scan 5 minutes after the lung biopsy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2026
- Study start1 May 2012
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pneumothorax Iatrogenic PostproceduralStudies of the same condition, open and under way.
- More trials run by St. Olavs HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,200 participants (actual)
- Target duration
- 1200 Days
Sponsor and investigators
- Lead sponsor
- St. Olavs Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07528170
- Sponsor's protocol ID
- 943833
- Acronym
- KELSO
- Status last verified
- Apr 2026
- First submitted
- 7 Apr 2026
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hajjar WM, Fetyani IM, Alqarni RM, Alajlan FA, Bahgat FF, Alharbi SR. Complications and Risk Factors of Patients Undergoing Computed Tomography-Guided Core Needle Lung Biopsy: A Single-Center Experience. Cureus. 2021 Aug 5;13(8):e16907. doi: 10.7759/cureus.16907. eCollection 2021 Aug.
PubMed 34513480Heerink WJ, de Bock GH, de Jonge GJ, Groen HJ, Vliegenthart R, Oudkerk M. Complication rates of CT-guided transthoracic lung biopsy: meta-analysis. Eur Radiol. 2017 Jan;27(1):138-148. doi: 10.1007/s00330-016-4357-8. Epub 2016 Apr 23.
PubMed 27108299
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Complications After CT-guided Lung Biopsies at St. Olavs Hospital
- ClinicalTrials.gov ID
- NCT07528170
- Acronym / sponsor ID
- KELSO / 943833
- Conditions
- Pneumothorax Iatrogenic Postprocedural, Air Embolism as A Complication of Medical Care, Hemoptysis
- Keywords
- Lung cancer, CT-guided lung biopsy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,200 participants (actual)
- Lead sponsor
- St. Olavs HospitalUniversity, hospital or other
- Study start
- 1 May 2012 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 14 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
At St. Olavs Hospital, a prospective collection of data on complications related to CT-guided lung biopsies has been conducted over several years as part of quality control study. The primary aim of this quality control study is to map complications in all patients who have undergone percutaneous CT-guided lung biopsy at St. Olavs Hospital from May 2012 to December 2023.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1200 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CT-guided lung biopsy | – | Procedure: CT-guided needle biopsy of lung noduleAll patient with a lung nodule eligible for CT-guided needle biopsy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 1200
Key inclusion criteria (1 listed)
- All patients eligible to a CT-guided needle biopsy of a lung nodule (allcomers)
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CT-guided needle biopsy of lung noduleThis is a simple needle biopsy of lung nodules guided with CT imaging | Procedure or surgery | CT-guided lung biopsy |
Primary outcome
Pneumothorax
Time frame: Patients are assessed with a CT scan 5 minutes after the lung biopsy
The frequency of pneumothorax after lung biopsy
Lung bleeding
Time frame: Patiens are assessed with a CT scan 5 minutes after the procedure
How frequent is parenchymal bleeding after lung biopsy
1 secondary outcome
Factors associated with complications after lung biopsy
Time frame: All patiens are assessed with CT scan 5 minutes after the lung biopsy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
- Background: PubMed 34513480Hajjar WM, Fetyani IM, Alqarni RM, Alajlan FA, Bahgat FF, Alharbi SR. Complications and Risk Factors of Patients Undergoing Computed Tomography-Guided Core Needle Lung Biopsy: A Single-Center Experience. Cureus. 2021 Aug 5;13(8):e16907. doi: 10.7759/cureus.16907. eCollection 2021 Aug.
- Background: PubMed 27108299Heerink WJ, de Bock GH, de Jonge GJ, Groen HJ, Vliegenthart R, Oudkerk M. Complication rates of CT-guided transthoracic lung biopsy: meta-analysis. Eur Radiol. 2017 Jan;27(1):138-148. doi: 10.1007/s00330-016-4357-8. Epub 2016 Apr 23.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Pneumothorax Iatrogenic Postprocedural and Air Embolism as A Complication of Medical Care, run by St. Olavs Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pneumothorax (time frame: Patients are assessed with a CT scan 5 minutes after the lung biopsy). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07528170, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2026.