Puncture Template Assisted Biopsy for Pulmonary Nodules

Study Overview
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Brief Summary
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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.

Official Title
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Puncture Template Assisted CT Guided Versus Simple CT Guided Biopsy for Small Pulmonary Nodules: a Multicenter, Prospective, Randomized Controlled Study

Conditions
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Pulmonary Nodule, CT Guided Biopsy

Intervention / Treatment
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* Behavioral: CT guided biopsy for pulmonary nodule


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Single or multiple pulmonary nodules (solid, partially solid, pure ground glass), with the maximum diameter of 5mm to 20mm and need for pathological diagnosis. No drugs affecting blood coagulation and (or) platelet aggregation were used; if used, the drugs had been stopped for enough time according to the drug elution period. KPS > 60, no serious or uncontrollable underlying diseases, the patients can tolerate lung puncture according to clinical evaluation. There is an appropriate puncture path. Exclusion Criteria: Poor lung function (such as FEV1 < 40% in the first second and / or DLCO < 50%) and / or isolated pulmonary bullae on the puncture path. The nodule is close to small airway and blood vessels, or has pulmonary hypertension and superior vena cava compression, so the risk of puncture bleeding and hemoptysis is expected to be high. Poor compliance, unable to complete the cooperation. Due to other reasons which is not suitable to participate in this clinical trial.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Puncture Template and CT group<br>Puncture Template assisted CT guided lung biopsy was performed. | Behavioral: CT guided biopsy for pulmonary nodule<br>* 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.<br>|
| Active Comparator: CT group<br>Simple CT guided lung biopsy was performed. | Behavioral: CT guided biopsy for pulmonary nodule<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Puncture 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. | Immediately after the operation (puncture). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 1 week to 1 month after operation (puncture). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pulmonary nodule, biopsy, puncture template