NCT04890301

Puncture Template Assisted Biopsy for Pulmonary Nodules

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 266 (estimated)
• Sponsor: Peking University Third Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Pulmonary Nodule
• CT Guided Biopsy

Interventions

Type	Name	Description
BEHAVIORAL	CT guided biopsy for pulmonary nodule	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.

Timeline

• Start date: 2021-06-01
• Primary completion: 2024-12-30
• Completion: 2025-05-31
• First posted: 2021-05-18
• Last updated: 2023-12-27

Locations

1 site across 1 country: China