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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.
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:
Lesion-specific factors:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Control | No Intervention | CT-guided lung biopsy will be performed per standard protocols |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rapid Rollover | Procedure | Repositioning of the participant post biopsy |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 hours after biopsy |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 24 hours for overnight observation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jae Ho Sohn, MD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zuckerberg San Francisco General Hospital and Trauma Center | San Francisco | California | 94110 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20173164 | Background | 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. | |
| 25636421 |
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Study results will be published.
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D011030 | Pneumothorax |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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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).
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Interpreting radiologists of the post-biopsy CTs and radiographs will be blinded to whether the patient is in the control or intervention group.
| 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. | From 2 hours post biopsy to patient being discharged home. |
| University of California, San Francisco |
| San Francisco |
| California |
| 94143 |
| United States |
| 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. |
| 22106349 | Background | 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. |
| 34726537 | Background | 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. |
| 12630999 | Background | Tanisaro K. Patient positioning after fine needle lung biopsy-effect on pneumothorax rate. Acta Radiol. 2003 Jan;44(1):52-5. |
| 9885587 | Background | 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. |
| 27108299 | Background | 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. |
| 31860329 | Background | 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. |
| 30863965 | Background | 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. |
| 16530369 | Background | 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. |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D010995 | Pleural Diseases |