Lung Cancer, Adenocarcinoma, Lung Inflammatory Pseudotumor
Conditions
Brief summary
The purpose of this study is to compare the diagnostic accuracy and complication rate between low-dose computed tomography-guided and standard-dose computed tomography-guided lung biopsy.
Detailed description
With the comprehensive usage of computed tomography examination, patients are more and more aware of the radiation dose of computed tomography. Concerns over the potential for radiation induced malignancies have increasingly been published in the scientific literature and reported in the popular press. The risk is highest for younger patients, who have more radiation-sensitive tissues and longer life expectancies than adults. Recently, the United States Food and Drug Administration announced an initiative to reduce unnecessary radiation exposure from medical imaging. At present, low-dose computed tomography protocol is widely used for the diagnosis of cardiovascular and cerebrovascular diseases. Computed tomography-guided lung biopsy is widely used for diagnosis of lung nodules and masses. However, it requires repeating scanning to guide the needles, which inevitably increases the radiation dose. Therefore, low-dose protocol was also used in the computed tomography-guided lung biopsy procedure. The purpose of this study is to compare the diagnostic accuracy and complication rate between low-dose computed tomography-guided and standard-dose computed tomography-guided lung biopsy.
Interventions
RADIATIONLow-dose protocol computed tomography
Radiation dose under the low-dose protocol computed tomography (120 kilovolt, 15 milliampere seconds)
RADIATIONStandard-dose protocol computed tomography
Radiation dose under the standard-dose protocol computed tomography (120 kilovolt, 150 milliampere seconds)
Sponsors
Xuzhou Central Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Non-diagnostic lung lesions; Solid lung lesions; Lesion size ≥ 5mm.
Exclusion criteria
* The lesion which has been punctured previously; Severe dysfunction in heart, lung and coagulation function.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic accuracy | From the date of randomization until the date of first documented final diagnosis, assessed up to 24 months | Diagnostic accuracy is defined as the biopsy diagnosis matches with the final diagnosis. The final diagnosis is made according to the surgical or follow-up findings. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complication | From the date of randomization until the date of first documented biopsy-related complication, assessed up to 1 day. | Biopsy-related complications mainly include pneumothorax and hemoptysis. Complications is evaluated by computed tomography scan and clinical symptoms. |
Countries
China
Outcome results
None listed