Evaluate the Diagnostic Value of BTPNA for PPL: a Real-world Study

NCT04597346 | Unknown DMC

• 1 other identifier: SHCHE202003
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The study is designed as a multicenter prospective trial of BTPNA for the diagnosis of peripheral pulmonary lesions in the real world. The purpose of the study is to evaluate the safety and effectiveness of BTPNA and to explore the factors of diagnosis rate.

Conditions

Peripheral Pulmonary Lesion

Keywords

Bronchoscopic Transparenchymal Nodule Access; Peripheral Pulmonary Lesion

Outcome Measures

Primary Outcomes (1)

• Diagnostic yield

  Diagnostic yield is defined as the proportion of lesions diagnosed by BTPNA in all lesions undergoing bronchoscopy biopsy by BTPNA.

  Six months

Secondary Outcomes (8)

• The success rate of navigation

  Immediately after bronchoscopic biopsy

• The success rate of biopsy

  Immediately after bronchoscopic biopsy

• The operation time of the bronchoscope

  Immediately after bronchoscopic biopsy

• The total time of lesion access

  Immediately after bronchoscopic biopsy

• The intraoperative fluoroscopy time

  Immediately after bronchoscopic biopsy

Interventions

Bronchoscopic Transparenchymal Nodule Access DEVICE

Bronchoscopic Transparenchymal Nodule Access (BTPNA) is locating the lesion in the lung tissue guided by the bronchoscope navigation system (LungPro) in the natural lumen (bronchus), and automatically calculates the best point of entry (POE) and the best route to avoid blood vessels. An opening is made from the POE under the endoscope, and is extended with a balloon dilator. Combined with X-ray fluoroscopy, a sheath with a blunt-tip core is used in the lung parenchyma to reach the lesion site, and then biopsy diagnosis or treatment.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Newly diagnosed patients whose chest CT showed suspect malignant peripheral lung lesion and are scheduled to receive non-surgical biopsies with lesion access via BTPNA.

You may qualify if:

• Patients older than 18 years old.
• Newly diagnosed patients whose chest CT shows peripheral pulmonary lesions that have bronchus signs but are difficult to reach through the intrabronchial path, or are adjacent to the airway, or have no bronchus sign, and are suspected of malignancy which need non-surgical biopsies.
• The diameter of the lesions is greater than or equal to 0.8cm and less than 5cm
• The location of lesions results in the following situations where transthoracic needle aspiration (TTNA) is difficult to obtain a diagnosis or the operation is relatively risky, or have not been diagnosed by TTNA and other non-surgical biopsies in the past.
• Lesions can be accessed by BTPNA technology in preoperative assessment.
• Understand the research and sign the informed consent form.

You may not qualify if:

• Contraindications for bronchoscopy.
• The lesions are adjacent to the target trachea or bronchus of points of entry(POE).
• Severe cardiopulmonary dysfunction and other diseases that may significantly increase the risk of surgery.
• Routine bronchoscopy showed visible lesions in the lumen.

Sponsors & Collaborators

• Shanghai Chest Hospital: lead
• Henan Provincial People's Hospital: collaborator
• Beijing Chao Yang Hospital: collaborator
• Shandong Public Health Clinical Center: collaborator
• West China Hospital: collaborator
• Second Affiliated Hospital of Guangzhou Medical University: collaborator
• Xi 'an International Medical Center Hospital: collaborator
• Emergency General Hospital: collaborator

Study Sites (1)

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, 200030, China

RECRUITING

Related Publications (7)

• Chechani V. Bronchoscopic diagnosis of solitary pulmonary nodules and lung masses in the absence of endobronchial abnormality. Chest. 1996 Mar;109(3):620-5. doi: 10.1378/chest.109.3.620.

  PMID: 8617067 RESULT

• Baaklini WA, Reinoso MA, Gorin AB, Sharafkaneh A, Manian P. Diagnostic yield of fiberoptic bronchoscopy in evaluating solitary pulmonary nodules. Chest. 2000 Apr;117(4):1049-54. doi: 10.1378/chest.117.4.1049.

  PMID: 10767238 RESULT

• Tamiya M, Okamoto N, Sasada S, Shiroyama T, Morishita N, Suzuki H, Yoshida E, Hirashima T, Kawahara K, Kawase I. Diagnostic yield of combined bronchoscopy and endobronchial ultrasonography, under LungPoint guidance for small peripheral pulmonary lesions. Respirology. 2013 Jul;18(5):834-9. doi: 10.1111/resp.12095.

  PMID: 23586738 RESULT

• Gilbert C, Akulian J, Amador RO, Lee H, Yarmus L. Novel bronchoscopic strategies for the diagnosis of peripheral lung lesions: present techniques and future directions. Respirology. 2014 Jul;19(5):636-44. doi: 10.1111/resp.12301. Epub 2014 May 6.

  PMID: 24797257 RESULT

• Sterman DH, Keast T, Rai L, Gibbs J, Wibowo H, Draper J, Herth FJ, Silvestri GA. High yield of bronchoscopic transparenchymal nodule access real-time image-guided sampling in a novel model of small pulmonary nodules in canines. Chest. 2015 Mar;147(3):700-707. doi: 10.1378/chest.14-0724.

  PMID: 25275338 RESULT

• Herth FJ, Eberhardt R, Sterman D, Silvestri GA, Hoffmann H, Shah PL. Bronchoscopic transparenchymal nodule access (BTPNA): first in human trial of a novel procedure for sampling solitary pulmonary nodules. Thorax. 2015 Apr;70(4):326-32. doi: 10.1136/thoraxjnl-2014-206211. Epub 2015 Mar 6.

  PMID: 25746631 RESULT

• Harzheim D, Sterman D, Shah PL, Eberhardt R, Herth FJ. Bronchoscopic Transparenchymal Nodule Access: Feasibility and Safety in an Endoscopic Unit. Respiration. 2016;91(4):302-6. doi: 10.1159/000445032. Epub 2016 Mar 24.

  PMID: 27007334 RESULT

Study Officials

• Jiayuan Sun, MD, PhD

  Shanghai Chest Hospital

  STUDY DIRECTOR

Central Study Contacts

Jiayuan Sun, MD, PhD

CONTACT

86-021-22200000; xkyyjysun@163.com

Jiayuan Sun, MD, PhD

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Department of Respiratory Endoscopy

Study Record Dates

• First Submitted: October 14, 2020
• First Posted: October 22, 2020
• Study Start: December 23, 2021
• Primary Completion: December 30, 2023
• Study Completion: June 30, 2024
• Last Updated: February 23, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)