Ignite Creation Date:
2024-05-19 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06419114
Status:
RECRUITING
Last Update Posted:
2024-05-20
First Post:
2024-05-10
Brief Title:
Exploration of Optical Coherence Tomography-Guided Transbronchial Biopsy in Peripheral Pulmonary Lesions
Sponsor:
Sichuan Provincial Peoples Hospital
Organization:
Sichuan Provincial Peoples Hospital
Study Overview
Official Title:
Exploration of Optical Coherence Tomography-Guided Transbronchial Biopsy in Peripheral Pulmonary Lesions
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OCTGTBIPPL
Brief Summary:
In this prospective analysis investigators collected and evaluated data from patients who underwent TBB at the Respiratory Endoscopy Center of Sichuan Provincial Peoples 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 PPLs 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 42mm R-EBUS system Olympus Japan incorporated an ultra-thin radial ultrasonic probe Olympus UM-S20-17S which measures merely 14mm in diameter The OCT Yongshida Medical Technology Guangdong China probe is a cylindrical catheter 17mm 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
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 PPLs 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 42mm R-EBUS system Olympus Japan incorporated an ultra-thin radial ultrasonic probe Olympus UM-S20-17S which measures merely 14mm in diameter The OCT Yongshida Medical Technology Guangdong China probe is a cylindrical catheter 17mm 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
Detailed Description:
See details inBrief summary
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None