Pulmonary nodules are small in size and easy to move with breathing. CT guided puncture is highly dependent on the personal experience of physicians, that is, the accuracy, efficiency and incidence of complications of puncture vary greatly among physicians. Puncture template (PT) assisted CT guided needle biopsy of pulmonary nodules has good clinical feasibility, which is expected to make up for the deficiency of simple CT guided needle biopsy, and make the needle biopsy of pulmonary nodules more accurate and standardized. This study intends to carry out a randomized controlled study to further evaluate the safety and effectiveness of PT assisted CT guided needle biopsy of pulmonary nodules, and provide higher quality data reference for its clinical application. Patients were randomly divided into two groups: PT assisted CT guided or simple CT guided lung biopsy. The operation related information, complications and postoperative pathological results of the two groups were collected. Primary end point: puncture accuracy Secondary end point: success rate of first needle puncture; complication rate (such as pneumothorax, bleeding, etc.); operation time; CT scan times; pathologic findings.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
266
The technical process of the experimental group: ① design of puncture path, positioning and fixation of patients; ② puncture point positioning; ③ installation of navigation frame and template; ④ percutaneous lung biopsy guided by PT combined with CT. The technical process of the active comparator group: ① planning puncture path, positioning and fixation of patients; ② positioning puncture point; ③ CT guided percutaneous lung biopsy. The operation related information, complications and postoperative pathological results were collected.
Peking University Third Hospital
Beijing, Beijing Municipality, China
RECRUITINGPuncture accuracy assessed by direct measurement.
The distance between the actual puncture point and the expected puncture point should be measured on CT image, to get whether there are any errors in the needle insertion of the two groups and whether there are differences between the two groups.
Time frame: Immediately after the operation (puncture).
Success rate of first needle puncture assessed by freqencey of needle adjustment.
The freqencey of times of needle adjustment should be recorded. If the frequency of puncture needle adjustment is 0, the first needle puncture was recorded as successful. If the frequency of needle adjustment is not 0, the number of times of needle adjustment should be recorded.
Time frame: Immediately after the operation (puncture).
Complications assessed by CTCAE 5.0
The incidence and severity of complications such as pneumothorax, subcutaneous emphysema, hemothorax, hemoptysis and air embolism should be recorded.
Time frame: From the beginning of operation to 1 month after operation (puncture).
Operation time assessed by direct timing.
The time from the first CT scan to the last CT scan should be recorded.
Time frame: Immediately after the operation (puncture).
Times of CT scans assessed by direct counting.
The total number of CT scans throughout the operation should be recorded.
Time frame: Immediately after the operation (puncture).
Pathological report issued by pathology department.
The pathological results (pathological report issued by pathology department) of puncture should be followed up and recorded. If the pathological results indicate normal tissue/structure, the puncture result is considered to be negative.
Time frame: 1 week to 1 month after operation (puncture).
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