The Diagnostic Yield and Safety of Transbronchial Cryobiopsy in The Pulmonary Periphral Nodule

Not Applicable

• Conditions: Complication Rate; Diagnosis

• Registration Number: NCT04661956
• Lead Sponsor: ShiYue Li

Brief Summary

Transbronchial cryobiopsy under the guidance of endobronchial ultrasound is performed in patients with pulmonary peripheral nodule, and assess the diagnostic yield and safety.

Detailed Description

Transbronchial cryobiopsy under the guidance of endobronchial ultrasound is performed in patients with pulmonary peripheral nodule, and assess the diagnostic yield and safety. This is a multi-center prospective randomized control trial.

Study Timeline

• Study First Submitted: 2020-10-26
• Study First Submitted QC: 2020-12-09
• Study First Posted: 2020-12-10
• Study Start: 2020-12-15
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-14
• Last Update Posted: 2021-10-15
• Primary Completion: 2022-06-15
• Study Completion: 2022-06-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

1. The patients are admitted as Pulmonary Periphral Nodule, while undefined after thorough history collection, laboratory examination and radiological data.
2. The longest diameter of the Pulmonary Periphral Nodule is less than 30mm in HRCT.
3. The Pulmonary Periphral Nodule can be detected by radial-EBUS
4. Transbronchial cryobiopsy(TBCB) is indicated by clinicians for definitive diagnosis and patients are content with the examination with agreement signed.
5. Routine blood test, ECG examination, coagulation function, chest HRCT have been completed.

Exclusion Criteria

1. The longest diameter of the Pulmonary Periphral Nodule is more than 30mm.
2. The Pulmonary Periphral lesions cannot be detected by the radial endobronchial ultrasound.
3. The clinical examinations mentioned above are not completed. The patient cannot endure or does not agree the procedure

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Diagnotic yield	six months	Percentage of definitive pathological diagnosis by transbronchial cryobiopsy

Secondary Outcome Measures

Name	Time	Method
Complication rate	one week	Incidence of bleeding, pneumothorax (during the procedure and within 7 days after the intervention

Trial Locations

Locations (24)

The First Affiliated Hospital of Bengbu Medical College; 🇨🇳 Bengbu, Anhui, China

AnHui Chest Hospital; 🇨🇳 Hefei, Anhui, China

China-Japan Friendship Hospital; 🇨🇳 Beijing, Beijing, China

Xiamen Second Hospital; 🇨🇳 Xiamen, Fujian, China

Lanzhou University Second Hospital; 🇨🇳 Lanzhou, Gansu, China

The First Hospital of Lanzhou University; 🇨🇳 Lanzhou, Gansu, China

Guangdong General Hospital; 🇨🇳 Guangzhou, Guangdong, China

The First Affiliated Hospital Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China

Southern Medical University Nanfang Hospital; 🇨🇳 Guangzhou, Guangdong, China

Peking University Shenzhen Hospital; 🇨🇳 Shenzhen, Guangdong, China

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