Puncture Template Assisted Biopsy for Pulmonary Nodules

Peking University

Status: Enrolling

Conditions: CT Guided Biopsy; Pulmonary Nodule

Treatments: Behavioral: CT guided biopsy for pulmonary nodule

Study type: Interventional

Funder types: Other

Identifiers

NCT04890301

CNRBG-2021-PT-PN

Details and patient eligibility

About

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.

Enrollment: 266 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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266 participants in 2 patient groups

Puncture Template and CT group

Experimental group

Description:

Puncture Template assisted CT guided lung biopsy was performed.

Treatment:

Behavioral: CT guided biopsy for pulmonary nodule

CT group

Active Comparator group

Description:

Simple CT guided lung biopsy was performed.

Treatment:

Behavioral: CT guided biopsy for pulmonary nodule