Puncture Template Assisted Biopsy for Pulmonary Nodules

Pulmonary Nodule Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04890301
• Other study ID #: CNRBG-2021-PT-PN
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2021
• Est. completion date: May 31, 2025

Study information

• Verified date: August 2023
• Source: Peking University Third Hospital
• Contact: Zhe Ji
• Phone: +8618710002823
• Email: aschoff[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 266
• Est. completion date: May 31, 2025
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• CT Guided Biopsy
• Multiple Pulmonary Nodules
• Pulmonary Nodule

Intervention

Behavioral:
• CT guided biopsy for pulmonary nodule
The technical process of the experimental group: ? design of puncture path, positioning and fixation of patients; ? puncture point positioning; ? installation of navigation frame and template; ? percutaneous lung biopsy guided by PT combined with CT. The technical process of the active comparator group: ? planning puncture path, positioning and fixation of patients; ? positioning puncture point; ? CT guided percutaneous lung biopsy. The operation related information, complications and postoperative pathological results were collected.

Locations

Country	Name	City	State
China	Peking University Third Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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).
Secondary	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).
Secondary	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).
Secondary	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).
Secondary	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).