Clinical trial NCT04890301: Puncture Template Assisted Biopsy for Pulmonary Nodules
Official title: Puncture Template Assisted CT Guided Versus Simple CT Guided Biopsy for Small Pulmonary Nodules: a Multicenter, Prospective, Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pulmonary Nodule
CT Guided Biopsy
Keywords: pulmonary nodule
biopsy
puncture template
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2021-05-18
Enrollment: 266
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


Eligibility 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.

Primary outcomes:
measure: Puncture accuracy assessed by direct measurement.
timeFrame: Immediately after the operation (puncture).
Secondary outcomes:
measure: Success rate of first needle puncture assessed by freqencey of needle adjustment.
timeFrame: Immediately after the operation (puncture).
measure: Complications assessed by CTCAE 5.0
timeFrame: From the beginning of operation to 1 month after operation (puncture).
measure: Operation time assessed by direct timing.
timeFrame: Immediately after the operation (puncture).
measure: Times of CT scans assessed by direct counting.
timeFrame: Immediately after the operation (puncture).
measure: Pathological report issued by pathology department.
timeFrame: 1 week to 1 month after operation (puncture).
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
Study officials:
affiliation: Peking University Third Hospital, Department of Radiation Oncology
name: Junjie Wang
role: PRINCIPAL_INVESTIGATOR
References: