Puncture Template Assisted Biopsy for Pulmonary Nodules

NCT04890301 | Unknown

• 1 other identifier: CNRBG-2021-PT-PN
• Study Type: interventional
• Target: 266
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Nodule; CT Guided Biopsy

Keywords

pulmonary nodule; biopsy; puncture template

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Success rate of first needle puncture assessed by freqencey of needle adjustment.

  Immediately after the operation (puncture).

• Complications assessed by CTCAE 5.0

  From the beginning of operation to 1 month after operation (puncture).

• Operation time assessed by direct timing.

  Immediately after the operation (puncture).

• Times of CT scans assessed by direct counting.

  Immediately after the operation (puncture).

• Pathological report issued by pathology department.

  1 week to 1 month after operation (puncture).

Study Arms (2)

Puncture Template and CT group

EXPERIMENTAL

Puncture Template assisted CT guided lung biopsy was performed.

Behavioral: CT guided biopsy for pulmonary nodule

CT group

ACTIVE COMPARATOR

Simple CT guided lung biopsy was performed.

Behavioral: CT guided biopsy for pulmonary nodule

Interventions

CT guided biopsy for pulmonary nodule BEHAVIORAL

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.

CT group; Puncture Template and CT group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

RECRUITING

Study Officials

• Junjie Wang

  Peking University Third Hospital, Department of Radiation Oncology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhe Ji

CONTACT

+8618710002823; aschoff@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2021
• First Posted: May 18, 2021
• Study Start: June 1, 2021
• Primary Completion: December 30, 2024
• Study Completion: May 31, 2025
• Last Updated: December 27, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Data will be available within 2 years of the study completion.
• 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.

Locations

CN (1)