Pulmonary NoduleNCT04890301
Puncture Template Assisted Biopsy for Pulmonary Nodules
A study testing CT guided biopsy for pulmonary nodule in people with Pulmonary Nodule and CT Guided Biopsy, run by Peking University Third Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pulmonary Nodule, CT Guided Biopsy
- What is being tested?
- CT guided biopsy for pulmonary nodule
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 266 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2021to 31 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
Zhe Ji, +8618710002823, aschoff@163.com
About this study
Official title: 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.
Read more
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
- Being tested
- CT guided biopsy for pulmonary nodule
- Keywords
- pulmonary nodule, biopsy, puncture template
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT guided biopsy for pulmonary noduleBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Puncture Template and CT group | Experimental | Puncture Template assisted CT guided lung biopsy was performed. Receives: Behavioral: CT guided biopsy for pulmonary nodule |
| CT group | Active comparator | Simple CT guided lung biopsy was performed. Receives: Behavioral: CT guided biopsy for pulmonary nodule |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Immediately after the operation (puncture).
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 week to 1 month after operation (puncture).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2021
- Study start1 Jun 2021
- Primary completion30 Dec 2024 (estimated)
- Study completion31 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary NoduleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 266 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Junjie Wang, Principal investigator, Peking University Third Hospital, Department of Radiation Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04890301
- Sponsor's protocol ID
- CNRBG-2021-PT-PN
- Status last verified
- Aug 2023
- First submitted
- 30 Apr 2021
- Last updated
- 27 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD will be available to other researchers and can be requested by the email of study sponsor.
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Puncture Template Assisted CT Guided Versus Simple CT Guided Biopsy for Small Pulmonary Nodules: a Multicenter, Prospective, Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04890301
- Acronym / sponsor ID
- CNRBG-2021-PT-PN
- Conditions
- Pulmonary Nodule, CT Guided Biopsy
- Keywords
- pulmonary nodule, biopsy, puncture template
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 266 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 31 May 2025 (estimated)
- First posted
- 18 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Puncture Template and CT group | Experimental | Behavioral: CT guided biopsy for pulmonary nodulePuncture Template assisted CT guided lung biopsy was performed. |
| CT group | Active comparator | Behavioral: CT guided biopsy for pulmonary noduleSimple CT guided lung biopsy was performed. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CT guided biopsy for pulmonary noduleThe 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. | Behavioural | CT group, Puncture Template and CT group |
Primary outcome
Puncture accuracy assessed by direct measurement.
Time frame: Immediately after the operation (puncture).
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.
5 secondary outcomes
Success rate of first needle puncture assessed by freqencey of needle adjustment.
Time frame: Immediately after the operation (puncture).
Complications assessed by CTCAE 5.0
Time frame: From the beginning of operation to 1 month after operation (puncture).
Operation time assessed by direct timing.
Time frame: Immediately after the operation (puncture).
Times of CT scans assessed by direct counting.
Time frame: Immediately after the operation (puncture).
Pathological report issued by pathology department.
Time frame: 1 week to 1 month after operation (puncture).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2023.
- Individual participant dataSharing planned: Yes. IPD will be available to other researchers and can be requested by the email of study sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Junjie Wang principal investigator
Peking University Third Hospital, Department of Radiation Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CT guided biopsy for pulmonary nodule in people with Pulmonary Nodule and CT Guided Biopsy, run by Peking University Third Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhe Ji (+8618710002823, aschoff@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Puncture accuracy assessed by direct measurement. (time frame: Immediately after the operation (puncture).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2023.