Role of Bronchoscope in Diagnosis of Lung Cancer

NCT ID: NCT05992740

Last Updated: 2023-09-14

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 65 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-01
• Study Completion Date: 2025-10-31

Brief Summary

The study aims to compare the diagnostic yields of bronchial brushing performed before and after forceps biopsy and bronchial wash performed before and after biopsy during flexible bronchoscopy.

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.

Conditions

Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

bronchial wash group

the patients will undergo bronchoscope then pre-biopsy bronchial wash, biopsy, post-biopsy bronchial wash will be obtained

Group Type: ACTIVE_COMPARATOR

bronchoscope

Intervention Type: DEVICE

bronchoscpe with broncial brush and biopsy or bronchial wash and biopsy

bronchial brush

the patients will undergo bronchoscope then pre-biopsy bronchial brush, biopsy, post-biopsy bronchial brush will be obtained

Group Type: ACTIVE_COMPARATOR

bronchoscope

Intervention Type: DEVICE

bronchoscpe with broncial brush and biopsy or bronchial wash and biopsy

Interventions

bronchoscope

bronchoscpe with broncial brush and biopsy or bronchial wash and biopsy

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Merna Maged Monir

principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

merna maged

Role: CONTACT

mernamaged1@gmail.com

+201284143158

manal ahmed

Role: CONTACT

+201009493236

References

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.

Reference Type: BACKGROUND

PMID: 27076949 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31974454 (View on PubMed)

Other Identifiers

bronchoscope in lung cancer

Identifier Type: -

Identifier Source: org_study_id