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Effect of Rapid Rollover on Pneumothorax After CT-Guided Lung Biopsy

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ClinicalTrials.gov Identifier: NCT05342675
Recruitment Status : Not yet recruiting
First Posted : April 25, 2022
Last Update Posted : April 25, 2022
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

Brief 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. 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.


Condition or disease Intervention/treatment Phase
Lung Cancer Pneumothorax Procedure: Rapid Rollover Not Applicable

Detailed Description:

All patients will undergo CT-guided lung biopsy by the best approach decided by the primary operator. In patients with the rapid rollover group, patient will be repositioned on the CT scanner table immediately after the co-axial needle is removed such that the biopsy site is down. Patient will be maintained in the same position for the post-biopsy CT scanner as well as in the post-procedure recovery area for at least 2 hours if patients can tolerate. All patients will be monitored for at least 2 hours, when a post-biopsy radiograph will be obtained to assess for pneumothorax. Interpreting radiologists of the post-biopsy radiographs will be blinded to whether the patient is in the control or intervention group.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 126 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Investigator)
Masking Description: Interpreting radiologists of the post-biopsy CTs and radiographs will be blinded to whether the patient is in the control or intervention group.
Primary Purpose: Prevention
Official Title: Effect of Post-Procedural Rapid Rollover on Pneumothorax After Percutaneous CT-Guided Lung Biopsy: A Randomized Controlled Trial
Estimated Study Start Date : July 1, 2022
Estimated Primary Completion Date : July 1, 2023
Estimated Study Completion Date : August 1, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Rapid Rollover
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.
Procedure: Rapid Rollover
Repositioning of the participant post biopsy

No Intervention: Control
CT-guided lung biopsy will be performed per standard protocols



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Chest tube insertion [ Time Frame: 24 hours for overnight observation ]
    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.

  2. Enlarging pneumothorax [ Time Frame: From 2 hours post biopsy to patient being discharged home. ]
    Enlarging pneumothorax from baseline pneumothorax > 3 mm (distance between visceral and parietal pleura measured on chest radiograph) accounting for redistribution of air and projection.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05342675


Contacts
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Contact: Jae Ho Sohn, MD 415-476-1000 jaeho.sohn@ucsf.edu
Contact: Xiao Wu, MD 415-476-1000 xiao.wu@ucsf.edu

Locations
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United States, California
University of California, San Francisco
San Francisco, California, United States, 94143
Contact: Xiao Wu, MD    415-476-8358    xiao.wu@ucsf.edu   
Principal Investigator: Jae Ho Sohn, MD         
Sponsors and Collaborators
University of California, San Francisco
Investigators
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Principal Investigator: Jae Ho Sohn, MD University of California, San Francisco
Publications:

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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT05342675    
Other Study ID Numbers: 22-36288
First Posted: April 25, 2022    Key Record Dates
Last Update Posted: April 25, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Study results will be published.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of California, San Francisco:
CT-guided lung biopsy
Chest tube
Additional relevant MeSH terms:
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Pneumothorax
Pleural Diseases
Respiratory Tract Diseases