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CT guided percutaneous biopsy for the accuracy of benign and malignant pulmonary nodules and complication rate: a multicenter, prospective, real-world study

CT guided percutaneous biopsy for the accuracy of benign and malignant pulmonary nodules and complication rate: a multicenter, prospective, real-world study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100044574
Enrollment
Unknown
Registered
2021-03-24
Start date
2021-04-01
Completion date
Unknown
Last updated
2021-09-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

lung nodule

Interventions

Gold Standard:1.Benign or malignant lesions: postoperative pathology is the standard. 2.Benign lesions should be diagnosed by clinical, imaging and pathologists together and follow up regularly for 2
Index test:Percutaneous biopsy

Sponsors

The First Affiliated Hospital of Army Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Age is 18-80 years old, gender is not limited; 2. ECoG 0-2; 3. The imaging findings were focal, round like, high density solid or sub solid lung shadow with diameter <= 3 cm; 4. Solitary and multiple nodules; 5. Suspected malignant ground glass nodules with ground glass diameter <= 3cm; 6. The imaging findings were suspicious of tumor, and the patients required preoperative biopsy; 7. The imaging findings were benign, and the patients required puncture biopsy; 8. Biopsy guided by CT; 9. Cutting needle was selected for biopsy; 10. Proficient in Chinese, no communication barriers, patients and their families signed informed consent before operation.

Exclusion criteria

Exclusion criteria: 1. Biopsy combined with ablation; 2. Patients after local treatment such as ablation and stereotactic therapy; 3. There were obvious bullae, bronchiectasis and infectious lesions in the biopsy path; 4. Those who have uncorrectable bleeding tendency or coagulation dysfunction, or need to take anticoagulant drugs continuously; 5. Patients with severe COPD or asthma; 6. Patients with previous history of malignant tumor or pathologically confirmed malignant lesions; 7. A history of unstable angina or myocardial infarction within 6 months; 8. Serious mental illness; 9. Pregnant and lactating women; 10. Suspected hydatid cyst and vascular malformation; 11. Severe cardiopulmonary insufficiency; 12. Patients who underwent needle aspiration biopsy.

Design outcomes

Primary

MeasureTime frame
The rate of benign and malignant diagnosis by biopsy;

Secondary

MeasureTime frame
Incidence of complications;

Countries

China

Contacts

Public ContactHe Chuang

The First Affiliated Hospital of Army Medical University

longtoo123@qq.com+86 13650584782

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026