Puncture Template Assisted Biopsy for Pulmonary Nodules
NCT ID: NCT04890301
Last Updated: 2023-12-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
266 participants
INTERVENTIONAL
2021-06-01
2025-05-31
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Puncture Template and CT group
Puncture Template assisted CT guided lung biopsy was performed.
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.
CT group
Simple CT guided lung biopsy was performed.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
80 Years
ALL
No
Sponsors
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Peking University Third Hospital
OTHER
Responsible Party
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Principal Investigators
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Junjie Wang
Role: PRINCIPAL_INVESTIGATOR
Peking University Third Hospital, Department of Radiation Oncology
Locations
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Peking University Third Hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Zhe Ji
Role: primary
Other Identifiers
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CNRBG-2021-PT-PN
Identifier Type: -
Identifier Source: org_study_id