Clinical trial NCT05342675: 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
Overall status: COMPLETED
Phase: NA
Conditions: Lung Cancer
Pneumothorax
Keywords: CT-guided lung biopsy
Chest tube
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2022-04-25
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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).
Primary purpose: PREVENTION

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

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

Primary outcomes:
measure: Radiographically detectable pneumothorax
timeFrame: 2 hours after biopsy
Secondary outcomes:
measure: Chest tube insertion
timeFrame: 24 hours for overnight observation
measure: Enlarging pneumothorax
timeFrame: From 2 hours post biopsy to patient being discharged home.
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Zuckerberg San Francisco General Hospital and Trauma Center
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Jae Ho Sohn, MD
role: PRINCIPAL_INVESTIGATOR
References:
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