- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05992740
Role of Bronchoscope in Diagnosis of Lung Cancer
The Optimal Sequence of Bronchial Brushing, Forceps Biopsy and Washing for Diagnosis of Lung Cancer
Study Overview
Detailed Description
Lung cancer is the most common cause of cancer-related mortality in both sexes in the world. To treat the disease successfully, it should be diagnosed at the earliest possible stage. Several studies have demonstrated that early detection, localization, and aggressive treatment of lung cancer result in the 5-year survival rate of 70-80%. Nowadays, bronchoscopy is an invaluable tool for diagnosis of lung cancer and various diagnostic tools have been developed using flexible fiber-optic bronchoscopy (FOB).
Bronchoscopy, while essential for diagnosing and staging lung cancer, can give variable diagnostic yields ranging from37-77%. One reason for this variability is limitations in tissue sampling techniques, which can make it impossible to obtain the most representative area of neoplastic tissue. Numerous basic diagnostic procedures using FB, including bronchoalveolar lavage or washing, brushing, endobronchial or transbronchial biopsy(TBB), and transbronchial needle aspiration, have been evaluated in various combinations to improve the diagnostic yield of FB in patients with suspected lung cancer. However, the optimum sequence of brushing, washing and biopsy samples for diagnosing peripheral lung cancer is not clear and requires further study.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: merna maged
- Phone Number: +201284143158
- Email: mernamaged1@gmail.com
Study Contact Backup
- Name: manal ahmed
- Phone Number: +201009493236
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Patients in whom clinical findings, radiological examination suggested lung malignancy. patients with chronic cough, hemoptysis and lymph node enlargement.
Exclusion Criteria:
patients with no evidence of malignancy.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: bronchial wash group
the patients will undergo bronchoscope then pre-biopsy bronchial wash, biopsy, post-biopsy bronchial wash will be obtained
|
bronchoscpe with broncial brush and biopsy or bronchial wash and biopsy
|
|
Active Comparator: bronchial brush
the patients will undergo bronchoscope then pre-biopsy bronchial brush, biopsy, post-biopsy bronchial brush will be obtained
|
bronchoscpe with broncial brush and biopsy or bronchial wash and biopsy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
comparison between diagnostic yields of different tissue sampling techniques of bronchoscope in lung cancer diagnosis
Time Frame: 2 years
|
we will compare between the diagnostic yield of bronchial brushing group (pre-biopsy brushing + forceps biopsy + post-biopsy brushing) with the diagnostic yield of bronchial wash group (pre-biopsy bronchial wash + biopsy + post-biopsy bronchial wash).
|
2 years
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Hou G, Miao Y, Hu XJ, Wang W, Wang QY, Wu GP, Wang EH, Kang J. The optimal sequence for bronchial brushing and forceps biopsy in lung cancer diagnosis: a random control study. J Thorac Dis. 2016 Mar;8(3):520-6. doi: 10.21037/jtd.2016.02.12.
- Lim JH, Kim MJ, Jeon SH, Park MH, Kim WY, Lee M, Kim JH, Kim JS, Kim YS, Kim L, Lee KH, Kwak SM, Shin H, Nam HS. The optimal sequence of bronchial brushing and washing for diagnosing peripheral lung cancer using non-guided flexible bronchoscopy. Sci Rep. 2020 Jan 23;10(1):1036. doi: 10.1038/s41598-020-58010-w.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- bronchoscope in lung cancer
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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