Biopsy technique for lung nodules using a puncture template
Puncture Template Assisted CT Guided Versus Simple CT Guided Biopsy for Small Pulmonary Nodules: a Multicenter, Prospective, Randomized Controlled Study
NA · Peking University Third Hospital · NCT04890301
This study tests if using a special template during lung biopsies can make the procedure safer and more accurate for patients with lung nodules compared to the usual method.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 266 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Peking University Third Hospital (other) |
| Locations | 1 site (Beijing, Beijing) |
| Trial ID | NCT04890301 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and effectiveness of a puncture template (PT) assisted CT guided needle biopsy for pulmonary nodules compared to a standard CT guided biopsy. Patients with single or multiple pulmonary nodules requiring pathological diagnosis will be randomly assigned to either the PT assisted group or the standard group. The study aims to improve the accuracy and standardization of lung biopsies, which can vary significantly based on physician experience. Data on operation-related information, complications, and postoperative results will be collected for analysis.
Who should consider this trial
Good fit: Ideal candidates include patients with single or multiple pulmonary nodules sized between 5mm to 20mm who require a pathological diagnosis and can tolerate lung puncture.
Not a fit: Patients with poor lung function, those with nodules near small airways or blood vessels, or those with serious underlying conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more accurate and safer biopsies for patients with pulmonary nodules.
How similar studies have performed: While the approach of using a puncture template is innovative, similar studies have shown varying success in improving biopsy accuracy.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Beijing, Beijing
- Peking University Third Hospital — Beijing, Beijing, China (RECRUITING)
Study contacts
- Principal investigator: Junjie Wang — Peking University Third Hospital, Department of Radiation Oncology
- Study coordinator: Zhe Ji
- Email: aschoff@163.com
- Phone: +8618710002823
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Pulmonary Nodule, CT Guided Biopsy, pulmonary nodule, biopsy, puncture template