跳至主要内容
临床试验/NCT06419114
NCT06419114招募中不适用

Exploration of Optical Coherence Tomography-Guided Transbronchial Biopsy in Peripheral Pulmonary Lesions

Sichuan Provincial People's Hospital1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2024年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
150
试验地点
1
主要终点
The diagnostic yield of OCT or R-EBUS-guided TBB in PPLs

研究概览

简要总结

In this prospective analysis, investigators collected and evaluated data from patients who underwent TBB at the Respiratory Endoscopy Center of Sichuan Provincial People's Hospital. The procedures utilized a novel approach combining OCT with R-EBUS for guidance. Eligibility for participation was determined based on established guidelines for the application of diagnostic flexible bronchoscopy in adults.

The admission criteria of this study were as followed: (1) voluntary participation and written informed consent signed, (2) age ≥ 18 years old, (3) the platelets count and PT, APTT tests were normal, (4) normal ECG, (5) found PPL's by chest computed tomography (CT) within 2 weeks and (6) could not detect the lesions through routine diagnostic bronchoscopy. The exclusion criteria of this study were as followed: (1) patients with contraindication of bronchoscopy (such as respiratory failure and acute cardio-cerebrovascular events), (2) patients who refuse biopsy because of physical reasons or personal wishes, (3) patients with the objective reasons (such as abundant blood supply around the lesion) who could not complete the biopsy, (4) patients who are participating in other clinical studies, (5) patients with poor compliance who are believed by the researchers to be unable to cooperate for the completion of the examination and follow-up, and (6) women who were pregnant.

R-EBUS and OCT In this study, all procedures were conducted using a standardized flexible bronchoscopy (Olympus, Japan) featuring an outer diameter of 4.2mm. R-EBUS system (Olympus, Japan) incorporated an ultra-thin radial ultrasonic probe (Olympus UM-S20-17S), which measures merely 1.4mm in diameter. The OCT (Yongshida Medical Technology, Guangdong, China) probe is a cylindrical catheter, 1.7mm in diameter and 150cm in length. Placing the probe through the working channel of bronchoscope for real time dynamic scanning of lesions.

Research Process In this study, the entirety of the procedures was performed by the same respiratory physician with 5 years of experience in respiratory endoscopic diagnosis and treatment, including preoperative evaluation, preparation, lesion localization and biopsy. The respiratory physician had examined the bilateral airways with flexible bronchoscopy after the completion of preoperative anesthesia and found no lesions. The subsequent step involved the precise placement of the OCT probe, guided by prior CT scan results. This stage was critical for marking the lesion, determining its nature (benign or malignant), and, in cases of malignancy, identifying its pathological classification. In instances where the OCT failed to identify any lesion, the R-EBUS was employed to facilitate lesion localization and biopsy. Conversely, when PPLs was detected via OCT, R-EBUS was additionally utilized to corroborate the PPLs localization and to assist in completing the biopsy procedure. For cases where OCT localization failed, R-EBUS would be used. After successful confirmation with R-EBUS, an attempt was made again to insert the OCT probe and completed biopsy. Rapid On-Site Evaluation (ROSE) was employed for the assessment of biopsy specimens. A total of five specimens were collected from each lesion and subjected to ROSE. In scenarios where ROSE provided a definitive diagnosis, no additional biopsies were deemed necessary. Conversely, in instances where ROSE yielded non-definitive results, further biopsy samples were obtained. All biopsy specimens were preserved in 10% formalin, preparing them for detailed histopathological analysis. The ultimate pathological diagnoses were determined based on the reports issued by the pathology department.

In this study, the demographics of all patients were documented, including age, gender, and smoking history. Additionally, detailed clinical parameters, such as the location and size of the lesions, airway grades (ranging from 0 to 24) that the PPLs located, location time of OCT and the number of specimens, were systematically recorded. investigators also conducted extensive follow-up to track histopathological outcomes, whether from surgical biopsies, CT-guided percutaneous transthoracic needle biopsies, or other diagnostic avenues, including chest CT performed two months post-procedure. All the patients were followed up by telephone or outpatient service on the 1st and 3rd day after the procedure, and adverse events were recorded. All individuals underwent general anesthesia and were fitted with a laryngeal mask.

详细描述

See details in"Brief summary"

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

The diagnostic yield of OCT or R-EBUS-guided TBB in PPLs

时间窗: baseline

Ability to locate PPLs

次要结局

  • The demographics of all patients(baseline and 2 months)
  • The pathological diagnostic value of OCT and R-EBUS(baseline)

研究者

发起方
Sichuan Provincial People's Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Guanghong Zhou

Attending physician

Sichuan Provincial People's Hospital

研究点 (1)

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