Effect of Rapid Rollover on Pneumothorax After CT-Guided Lung Biopsy
Primary Purpose
Lung Cancer, Pneumothorax
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Rapid Rollover
Sponsored by
About this trial
This is an interventional prevention trial for Lung Cancer focused on measuring CT-guided lung biopsy, Chest tube
Eligibility 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
Sites / Locations
- Zuckerberg San Francisco General Hospital and Trauma CenterRecruiting
- University of California, San FranciscoRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Rapid Rollover
Control
Arm Description
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.
CT-guided lung biopsy will be performed per standard protocols
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT05342675
First Posted
April 1, 2022
Last Updated
December 16, 2022
Sponsor
University of California, San Francisco
1. Study Identification
Unique Protocol Identification Number
NCT05342675
Brief Title
Effect of Rapid Rollover on Pneumothorax After CT-Guided Lung Biopsy
Official Title
Effect of Post-Procedural Rapid Rollover on Pneumothorax After Percutaneous CT-Guided Lung Biopsy: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 15, 2022 (Actual)
Primary Completion Date
September 1, 2023 (Anticipated)
Study Completion Date
November 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer, Pneumothorax
Keywords
CT-guided lung biopsy, Chest tube
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
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.
Allocation
Randomized
Enrollment
126 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Rapid Rollover
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
CT-guided lung biopsy will be performed per standard protocols
Intervention Type
Procedure
Intervention Name(s)
Rapid Rollover
Intervention Description
Repositioning of the participant post biopsy
Primary Outcome Measure Information:
Title
Radiographically detectable pneumothorax
Description
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.
Time Frame
2 hours after biopsy
Secondary Outcome Measure Information:
Title
Chest tube insertion
Description
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.
Time Frame
24 hours for overnight observation
Title
Enlarging pneumothorax
Description
Enlarging pneumothorax from baseline pneumothorax > 3 mm (distance between visceral and parietal pleura measured on chest radiograph) accounting for redistribution of air and projection.
Time Frame
From 2 hours post biopsy to patient being discharged home.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jae Ho Sohn, MD
Phone
415-476-1000
Email
jaeho.sohn@ucsf.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Xiao Wu, MD
Phone
415-476-1000
Email
xiao.wu@ucsf.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jae Ho Sohn, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zuckerberg San Francisco General Hospital and Trauma Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiao Wu, MD
Email
xiao.wu@ucsf.edu
First Name & Middle Initial & Last Name & Degree
Jae Ho Sohn, MD
Email
jaeho.sohn@ucsf.edu
First Name & Middle Initial & Last Name & Degree
Jae Ho Sohn, MD
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiao Wu, MD
Phone
415-476-8358
Email
xiao.wu@ucsf.edu
First Name & Middle Initial & Last Name & Degree
Jae Ho Sohn, MD
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Study results will be published.
Citations:
PubMed Identifier
20173164
Citation
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.
Results Reference
background
PubMed Identifier
25636421
Citation
Kim 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.
Results Reference
background
PubMed Identifier
22106349
Citation
O'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.
Results Reference
background
PubMed Identifier
34726537
Citation
Najafi 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.
Results Reference
background
PubMed Identifier
12630999
Citation
Tanisaro K. Patient positioning after fine needle lung biopsy-effect on pneumothorax rate. Acta Radiol. 2003 Jan;44(1):52-5.
Results Reference
background
PubMed Identifier
9885587
Citation
Collings 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.
Results Reference
background
PubMed Identifier
27108299
Citation
Heerink 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.
Results Reference
background
PubMed Identifier
31860329
Citation
Huo 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.
Results Reference
background
PubMed Identifier
30863965
Citation
Huo 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.
Results Reference
background
PubMed Identifier
16530369
Citation
Tomiyama 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.
Results Reference
background
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Effect of Rapid Rollover on Pneumothorax After CT-Guided Lung Biopsy
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