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Puncture Template Assisted Biopsy for Pulmonary Nodules

NCT04890301 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 266

Last updated 2023-12-27

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Peking University Third Hospital

    lead OTHER

Principal Investigators

  • Junjie Wang · Peking University Third Hospital, Department of Radiation Oncology

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-01
Primary Completion
2024-12-30
Completion
2025-05-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04890301 on ClinicalTrials.gov