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

Lung Cancer Clinical Trial

Official title:

Effect of Post-Procedural Rapid Rollover on Pneumothorax After Percutaneous CT-Guided Lung Biopsy: A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05342675
• Other study ID #: 22-36288
• Status: Recruiting
• Phase: N/A
• Start date: September 15, 2022
• Est. completion date: June 30, 2024

Study information

• Verified date: November 2023
• Source: University of California, San Francisco
• Contact: Jae Ho Sohn, MD
• Phone: 415-476-1000
• Email: jaeho.sohn[@]ucsf.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 126
• Est. completion date: June 30, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Cancer
• Pneumothorax

Intervention

Procedure:
• Rapid Rollover
Repositioning of the participant post biopsy

Locations

Country	Name	City	State
United States	University of California, San Francisco	San Francisco	California
United States	Zuckerberg San Francisco General Hospital and Trauma Center	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

References & Publications (10)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Tanisaro K. Patient positioning after fine needle lung biopsy-effect on pneumothorax rate. Acta Radiol. 2003 Jan;44(1):52-5. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	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.