Lung CancerNCT05342675
Effect of Rapid Rollover on Pneumothorax After CT-Guided Lung Biopsy
A study testing Rapid Rollover in people with Lung Cancer and Pneumothorax, run by University of California, San Francisco at 2 sites in United States.
Trial summary
Pneumothorax is the most common complication after CT-guided lung biopsy, and several techniques have been proposed to reduce the risk. Among them, rapid rollover is the maneuver to immediately reposition the patient, with biopsy-side down after removal of biopsy needle. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Pneumothorax
- What is being tested?
- Rapid Rollover
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Sep 2022to 30 Jun 2024
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients who are referred to the Department of Radiology and Biomedical Imaging Cardiac and Pulmonary Imaging section for CT-guided lung biopsy will be screened for eligibility. All eligible patients will be enrolled. Patients who develop intra-procedural pneumothorax will be analyzed but excluded from the final analysis.
Who cannot join
- Patients with chest wall, subpleural or mediastinal lesions
- Patients who develop intra-procedural pneumothorax
- Patients who are biopsied by a prone approach
- Patients who are repositioned intra-procedurally
- Patients who are unable to tolerate reposition or have spinal precautions
- Patients who develop hemothorax and a chest tube is inserted for this indication
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Zuckerberg San Francisco General Hospital and Trauma Center
San Francisco, California, 94110
University of California, San Francisco
San Francisco, California, 94143
About this study
Official title: Effect of Post-Procedural Rapid Rollover on Pneumothorax After Percutaneous CT-Guided Lung Biopsy: A Randomized Controlled Trial
Pneumothorax is the most common complication after CT-guided lung biopsy, and several techniques have been proposed to reduce the risk. Among them, rapid rollover is the maneuver to immediately reposition the patient, with biopsy-side down after removal of biopsy needle. It has been theorized that the technique reduces the size of alveoli surrounding the needle tract, leading to airway closure and reduction in the alveolar-to-pleural pressure gradient, thereby preventing pneumothorax. The aim of this study is to evaluate the effectiveness of rapid rollover in reducing the risk of radiographically detectable pneumothorax and the rate of chest tube insertion.
Patients undergoing CT-guided lung biopsy for any indication will be recruited and randomized into either rapid rollover group or control group. In the control group, CT guided lung biopsy will be performed per standard protocols; in the rapid rollover group, the biopsy will also be performed per the same protocol with the addition of rapid rollover at the end of the procedure. For both groups, the primary outcome would be new or enlarging pneumothorax detected on post-biopsy radiographs, and the secondary outcome would be the risk of pneumothorax necessitating chest tube insertion, all complications associated with CT guided lung biopsy, time to complication development, and patient experience in each arm.
Read the detailed description
All patients will undergo CT-guided lung biopsy by the best approach decided by the primary operator. Randomization will be performed based on parity of patients' medical record numbers, which were assigned randomly at their first presentation. Patients with even medical record numbers will be assigned to the control group and patients with odd medical record number will be assigned to the intervention group.
In the rapid rollover group, patients will be repositioned upon being transferred from the CT scanner table to the stretcher such that the biopsy site is down. Patient in the intervention arm will be maintained in the same position in the post-procedure recovery area for at least 2 hours if patients can tolerate. Anyone who maintains the biopsy-site down position for at least 30 minutes after repositioning in the intervention group will be considered as completion of the intervention. Patients who are in the controlled arm may choose the most comfortable position per their preferences. All patients will be monitored for at least 2 hours, after which a 0-1 hour optional post-biopsy radiograph and 2-hour follow-up radiograph will be obtained to assess for pneumothorax per the standard current protocol. Further follow-up radiograph may be obtained if the patient did not receive the 0-1 hour radiograph and the 2-hour radiograph was positive for pneumothorax that is not large enough to require immediate chest tube insertion. Interpreting radiologists of the post-biopsy radiographs will be blinded to whether the patient is in the control or intervention group.
A survey will be given to the patients in post-anesthesia care unit by nurses before they are discharged.
Multiple patient-, lesion- and technique-specific factors will be recorded:
Patient-specific factors:
- Age
- Gender
- Indication of lung biopsy
- History of underlying lung disease
- History of tobacco use
- Prior lung surgery or radiation
Lesion-specific factors:
- Location
- Size
- Morphology
- Shortest distance from pleura Technique-specific factors
- Approach
- Patient positioning during procedure
- Number of times crossing the pleura
- Number of times crossing the fissure
- Number of fine needle aspirations (FNAs)
- Number of core biopsies
- Needle-path length
- Needle-pleura angle
- Co-axial size
- Duration of biopsy site down time and number of turns as tolerated by the patient
- Use of blood patch
- Conditions
- Lung Cancer, Pneumothorax
- Being tested
- Rapid Rollover
- Keywords
- CT-guided lung biopsy, Chest tube
- Medical subject headings
- Lung Neoplasms, Pneumothorax
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rapid RolloverProcedure or surgery
Repositioning of the participant post biopsy
| Study group | Role | What they receive |
|---|---|---|
| Rapid Rollover | Experimental | Participants will have their body re-positioned upon being transferred to the stretcher from the CT scanner table such that the biopsy site is down. Participants will be maintained in the same position for the post-biopsy CT scanner as well as in the post-procedure recovery area for a minimum of 2 hours. Receives: Procedure: Rapid Rollover |
| Control | No intervention | CT-guided lung biopsy will be performed per standard protocols |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographically detectable pneumothorax
New or enlarging pneumothorax (from intraprocedural CT) which is detectable on post biopsy radiograph. The size of the pneumothorax will be measured in terms of the distance between visceral and parietal pleura. The severity of pneumothorax will be assessed using CTCAE 5.0.
Measured: 2 hours after biopsy
Secondary outcomes (2)
Chest tube insertion
Pneumothorax that requires chest tube insertion or other operative interventions (or CTCAE 5.0 grade 2 and above). While the decision to intervene could be operator-dependent, chest tube insertion takes place at our institution for patients with 1) enlarging or symptomatic small pneumothorax, and 2) moderate pneumothorax regardless of symptoms.
Measured: 24 hours for overnight observation
Enlarging pneumothorax
Enlarging pneumothorax from baseline pneumothorax > 3 mm (distance between visceral and parietal pleura measured on chest radiograph) accounting for redistribution of air and projection.
Measured: From 2 hours post biopsy to patient being discharged home.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2022
- Study start15 Sep 2022
- Primary completion30 Dec 2023
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial. Eligible patients will be randomized into either the control group (standard protocol CT-guided lung biopsy) or the rapid rollover group (immediate reposition with biopsy site down).
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jae Ho Sohn, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05342675
- Sponsor's protocol ID
- 22-36288
- Status last verified
- Jun 2025
- First submitted
- 1 Apr 2022
- Last updated
- 12 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Study results will be published.
Publications
Hiraki T, Mimura H, Gobara H, Shibamoto K, Inoue D, Matsui Y, Kanazawa S. Incidence of and risk factors for pneumothorax and chest tube placement after CT fluoroscopy-guided percutaneous lung biopsy: retrospective analysis of the procedures conducted over a 9-year period. AJR Am J Roentgenol. 2010 Mar;194(3):809-14. doi: 10.2214/AJR.09.3224.
PubMed 20173164Kim JI, Park CM, Lee SM, Goo JM. Rapid needle-out patient-rollover approach after cone beam CT-guided lung biopsy: effect on pneumothorax rate in 1,191 consecutive patients. Eur Radiol. 2015 Jul;25(7):1845-53. doi: 10.1007/s00330-015-3601-y. Epub 2015 Feb 1.
PubMed 25636421O'Neill AC, McCarthy C, Ridge CA, Mitchell P, Hanrahan E, Butler M, Keane MP, Dodd JD. Rapid needle-out patient-rollover time after percutaneous CT-guided transthoracic biopsy of lung nodules: effect on pneumothorax rate. Radiology. 2012 Jan;262(1):314-9. doi: 10.1148/radiol.11103506. Epub 2011 Nov 21.
PubMed 22106349Najafi A, Al Ahmar M, Bonnet B, Delpla A, Kobe A, Madani K, Roux C, Deschamps F, de Baere T, Tselikas L. The PEARL Approach for CT-guided Lung Biopsy: Assessment of Complication Rate. Radiology. 2022 Feb;302(2):473-480. doi: 10.1148/radiol.2021210360. Epub 2021 Nov 2.
PubMed 34726537Tanisaro K. Patient positioning after fine needle lung biopsy-effect on pneumothorax rate. Acta Radiol. 2003 Jan;44(1):52-5.
PubMed 12630999Collings CL, Westcott JL, Banson NL, Lange RC. Pneumothorax and dependent versus nondependent patient position after needle biopsy of the lung. Radiology. 1999 Jan;210(1):59-64. doi: 10.1148/radiology.210.1.r99ja1759.
PubMed 9885587Heerink 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 27108299Huo YR, Chan MV, Habib AR, Lui I, Ridley L. Pneumothorax rates in CT-Guided lung biopsies: a comprehensive systematic review and meta-analysis of risk factors. Br J Radiol. 2020 Apr 1;93(1108):20190866. doi: 10.1259/bjr.20190866. Epub 2020 Jan 3.
PubMed 31860329Huo YR, Chan MV, Habib AR, Lui I, Ridley L. Post-Biopsy Manoeuvres to Reduce Pneumothorax Incidence in CT-Guided Transthoracic Lung Biopsies: A Systematic Review and Meta-analysis. Cardiovasc Intervent Radiol. 2019 Aug;42(8):1062-1072. doi: 10.1007/s00270-019-02196-8. Epub 2019 Mar 12.
PubMed 30863965Tomiyama N, Yasuhara Y, Nakajima Y, Adachi S, Arai Y, Kusumoto M, Eguchi K, Kuriyama K, Sakai F, Noguchi M, Murata K, Murayama S, Mochizuki T, Mori K, Yamada K. CT-guided needle biopsy of lung lesions: a survey of severe complication based on 9783 biopsies in Japan. Eur J Radiol. 2006 Jul;59(1):60-4. doi: 10.1016/j.ejrad.2006.02.001. Epub 2006 Mar 10.
PubMed 16530369
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Post-Procedural Rapid Rollover on Pneumothorax After Percutaneous CT-Guided Lung Biopsy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05342675
- Acronym / sponsor ID
- 22-36288
- Conditions
- Lung Cancer, Pneumothorax
- Keywords
- CT-guided lung biopsy, Chest tube
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 15 Sep 2022 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 25 Apr 2022 (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.
Pneumothorax is the most common complication after CT-guided lung biopsy, and several techniques have been proposed to reduce the risk. Among them, rapid rollover is the maneuver to immediately reposition the patient, with biopsy-side down after removal of biopsy needle. It has been theorized that the technique reduces the size of alveoli surrounding the needle tract, leading to airway closure and reduction in the alveolar-to-pleural pressure gradient, thereby preventing pneumothorax. The aim of this study is to evaluate the effectiveness of rapid rollover in reducing the risk of radiographically detectable pneumothorax and the rate of chest tube insertion.
Patients undergoing CT-guided lung biopsy for any indication will be recruited and randomized into either rapid rollover group or control group. In the control group, CT guided lung biopsy will be performed per standard protocols; in the rapid rollover group, the biopsy will also be performed per the same protocol with the addition of rapid rollover at the end of the procedure. For both groups, the primary outcome would be new or enlarging pneumothorax detected on post-biopsy radiographs, and the secondary outcome would be the risk of pneumothorax necessitating chest tube insertion, all complications associated with CT guided lung biopsy, time to complication development, and patient experience in each arm.
Detailed description
All patients will undergo CT-guided lung biopsy by the best approach decided by the primary operator. Randomization will be performed based on parity of patients' medical record numbers, which were assigned randomly at their first presentation. Patients with even medical record numbers will be assigned to the control group and patients with odd medical record number will be assigned to the intervention group.
In the rapid rollover group, patients will be repositioned upon being transferred from the CT scanner table to the stretcher such that the biopsy site is down. Patient in the intervention arm will be maintained in the same position in the post-procedure recovery area for at least 2 hours if patients can tolerate. Anyone who maintains the biopsy-site down position for at least 30 minutes after repositioning in the intervention group will be considered as completion of the intervention. Patients who are in the controlled arm may choose the most comfortable position per their preferences. All patients will be monitored for at least 2 hours, after which a 0-1 hour optional post-biopsy radiograph and 2-hour follow-up radiograph will be obtained to assess for pneumothorax per the standard current protocol. Further follow-up radiograph may be obtained if the patient did not receive the 0-1 hour radiograph and the 2-hour radiograph was positive for pneumothorax that is not large enough to require immediate chest tube insertion. Interpreting radiologists of the post-biopsy radiographs will be blinded to whether the patient is in the control or intervention group.
A survey will be given to the patients in post-anesthesia care unit by nurses before they are discharged.
Multiple patient-, lesion- and technique-specific factors will be recorded:
Patient-specific factors:
- Age
- Gender
- Indication of lung biopsy
- History of underlying lung disease
- History of tobacco use
- Prior lung surgery or radiation
Lesion-specific factors:
- Location
- Size
- Morphology
- Shortest distance from pleura Technique-specific factors
- Approach
- Patient positioning during procedure
- Number of times crossing the pleura
- Number of times crossing the fissure
- Number of fine needle aspirations (FNAs)
- Number of core biopsies
- Needle-path length
- Needle-pleura angle
- Co-axial size
- Duration of biopsy site down time and number of turns as tolerated by the patient
- Use of blood patch
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Randomized controlled trial. Eligible patients will be randomized into either the control group (standard protocol CT-guided lung biopsy) or the rapid rollover group (immediate reposition with biopsy site down).
| Arm | Type | Receives |
|---|---|---|
| Rapid Rollover | Experimental | Procedure: Rapid RolloverParticipants will have their body re-positioned upon being transferred to the stretcher from the CT scanner table such that the biopsy site is down. Participants will be maintained in the same position for the post-biopsy CT scanner as well as in the post-procedure recovery area for a minimum of 2 hours. |
| Control | No intervention | –CT-guided lung biopsy will be performed per standard protocols |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients who are referred to the Department of Radiology and Biomedical Imaging Cardiac and Pulmonary Imaging section for CT-guided lung biopsy will be screened for eligibility. All eligible patients will be enrolled. Patients who develop intra-procedural pneumothorax will be analyzed but excluded from the final analysis.
Key exclusion criteria (6 listed)
- Patients with chest wall, subpleural or mediastinal lesions
- Patients who develop intra-procedural pneumothorax
- Patients who are biopsied by a prone approach
- Patients who are repositioned intra-procedurally
- Patients who are unable to tolerate reposition or have spinal precautions
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 |
|---|---|---|
| Rapid RolloverRepositioning of the participant post biopsy | Procedure or surgery | Rapid Rollover |
Primary outcome
Radiographically detectable pneumothorax
Time frame: 2 hours after biopsy
New or enlarging pneumothorax (from intraprocedural CT) which is detectable on post biopsy radiograph. The size of the pneumothorax will be measured in terms of the distance between visceral and parietal pleura. The severity of pneumothorax will be assessed using CTCAE 5.0.
2 secondary outcomes
Chest tube insertion
Time frame: 24 hours for overnight observation
Enlarging pneumothorax
Time frame: From 2 hours post biopsy to patient being discharged home.
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 12 Jun 2025.
- Background: PubMed 20173164Hiraki T, Mimura H, Gobara H, Shibamoto K, Inoue D, Matsui Y, Kanazawa S. Incidence of and risk factors for pneumothorax and chest tube placement after CT fluoroscopy-guided percutaneous lung biopsy: retrospective analysis of the procedures conducted over a 9-year period. AJR Am J Roentgenol. 2010 Mar;194(3):809-14. doi: 10.2214/AJR.09.3224.
- Background: PubMed 25636421Kim JI, Park CM, Lee SM, Goo JM. Rapid needle-out patient-rollover approach after cone beam CT-guided lung biopsy: effect on pneumothorax rate in 1,191 consecutive patients. Eur Radiol. 2015 Jul;25(7):1845-53. doi: 10.1007/s00330-015-3601-y. Epub 2015 Feb 1.
- Background: PubMed 22106349O'Neill AC, McCarthy C, Ridge CA, Mitchell P, Hanrahan E, Butler M, Keane MP, Dodd JD. Rapid needle-out patient-rollover time after percutaneous CT-guided transthoracic biopsy of lung nodules: effect on pneumothorax rate. Radiology. 2012 Jan;262(1):314-9. doi: 10.1148/radiol.11103506. Epub 2011 Nov 21.
- Background: PubMed 34726537Najafi A, Al Ahmar M, Bonnet B, Delpla A, Kobe A, Madani K, Roux C, Deschamps F, de Baere T, Tselikas L. The PEARL Approach for CT-guided Lung Biopsy: Assessment of Complication Rate. Radiology. 2022 Feb;302(2):473-480. doi: 10.1148/radiol.2021210360. Epub 2021 Nov 2.
- Background: PubMed 12630999Tanisaro K. Patient positioning after fine needle lung biopsy-effect on pneumothorax rate. Acta Radiol. 2003 Jan;44(1):52-5.
- Background: PubMed 9885587Collings CL, Westcott JL, Banson NL, Lange RC. Pneumothorax and dependent versus nondependent patient position after needle biopsy of the lung. Radiology. 1999 Jan;210(1):59-64. doi: 10.1148/radiology.210.1.r99ja1759.
- 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.
- Background: PubMed 31860329Huo YR, Chan MV, Habib AR, Lui I, Ridley L. Pneumothorax rates in CT-Guided lung biopsies: a comprehensive systematic review and meta-analysis of risk factors. Br J Radiol. 2020 Apr 1;93(1108):20190866. doi: 10.1259/bjr.20190866. Epub 2020 Jan 3.
- Background: PubMed 30863965Huo YR, Chan MV, Habib AR, Lui I, Ridley L. Post-Biopsy Manoeuvres to Reduce Pneumothorax Incidence in CT-Guided Transthoracic Lung Biopsies: A Systematic Review and Meta-analysis. Cardiovasc Intervent Radiol. 2019 Aug;42(8):1062-1072. doi: 10.1007/s00270-019-02196-8. Epub 2019 Mar 12.
- Background: PubMed 16530369Tomiyama N, Yasuhara Y, Nakajima Y, Adachi S, Arai Y, Kusumoto M, Eguchi K, Kuriyama K, Sakai F, Noguchi M, Murata K, Murayama S, Mochizuki T, Mori K, Yamada K. CT-guided needle biopsy of lung lesions: a survey of severe complication based on 9783 biopsies in Japan. Eur J Radiol. 2006 Jul;59(1):60-4. doi: 10.1016/j.ejrad.2006.02.001. Epub 2006 Mar 10.
- Individual participant dataSharing planned: No. Study results will be published.
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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.
Jae Ho Sohn, MD principal investigator
University of California, San Francisco
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rapid Rollover in people with Lung Cancer and Pneumothorax, run by University of California, San Francisco at 2 sites in United States.
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 6 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 12 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Radiographically detectable pneumothorax (time frame: 2 hours after biopsy). 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 NCT05342675, which also lists 10 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 12 Jun 2025.