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

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.

Study Overview

• Status: Recruiting
• Conditions: Pulmonary Nodule; CT Guided Biopsy
• Intervention / Treatment: Behavioral: CT guided biopsy for pulmonary nodule

• Study Type: Interventional
• Enrollment (Estimated): 266
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zhe Ji; Phone Number: +8618710002823; Email: aschoff@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100191
      • Recruiting
      • Peking University Third Hospital
      • Contact: Zhe Ji; Phone Number: +8618710002823; Email: aschoff@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Puncture Template and CT group; Puncture Template assisted CT guided lung biopsy was performed.	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.
Active Comparator: CT group; Simple CT guided lung biopsy was performed.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).
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).
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).
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).
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).

Collaborators and Investigators

• Sponsor: Peking University Third Hospital
• Investigators: Principal Investigator: Junjie Wang, Peking University Third Hospital, Department of Radiation Oncology

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2021
• Primary Completion (Estimated): December 30, 2024
• Study Completion (Estimated): May 31, 2025

Study Registration Dates

• First Submitted: April 30, 2021
• First Submitted That Met QC Criteria: May 12, 2021
• First Posted (Actual): May 18, 2021

Study Record Updates

• Last Update Posted (Actual): December 27, 2023
• Last Update Submitted That Met QC Criteria: December 22, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: biopsy; pulmonary nodule; puncture template
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Multiple Pulmonary Nodules
• Other Study ID Numbers: CNRBG-2021-PT-PN

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: IPD will be available to other researchers and can be requested by the email of study sponsor.
• IPD Sharing Time Frame: Data will be available within 2 years of the study completion.
• IPD Sharing Access Criteria: The purpose needs to be informed to and judged by the research sponsor. Requestors will be required to sign a Data Access Agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No