Role of Bronchoscope in Diagnosis of Lung Cancer

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05992740
Collaborator
(none)
65
2
25

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: bronchoscope
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
65 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
analytical cross sectionalanalytical cross sectional
Masking:
Single (Participant)
Primary Purpose:
Diagnostic
Official Title:
The Optimal Sequence of Bronchial Brushing, Forceps Biopsy and Washing for Diagnosis of Lung Cancer
Anticipated Study Start Date :
Sep 1, 2023
Anticipated Primary Completion Date :
Sep 1, 2025
Anticipated Study Completion Date :
Oct 1, 2025

Arms and Interventions

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

Device: bronchoscope
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

Device: bronchoscope
bronchoscpe with broncial brush and biopsy or bronchial wash and biopsy

Outcome Measures

Primary Outcome Measures

  1. comparison between diagnostic yields of different tissue sampling techniques of bronchoscope in lung cancer diagnosis [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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Patients ≥18 years old of both genders. Patients (65 cases) in whom clinical findings, radiological examination suggested lung malignancy. Chronic cough, hemoptysis, significant weight loss, pallor, and lymphadenopathy were among the most significant clinical findings that were considered.
Exclusion Criteria:
  • Children less than 18 years. Patients refusal to participate in the study.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Merna Maged Monir, resident physician, Assiut University
ClinicalTrials.gov Identifier:
NCT05992740
Other Study ID Numbers:
  • bronchoscope in lung cancer
First Posted:
Aug 15, 2023
Last Update Posted:
Aug 15, 2023
Last Verified:
Aug 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 15, 2023