NCT05992740

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
65

participants targeted

Target at P25-P50 for not_applicable lung-cancer

Timeline
Completed

Started Oct 2023

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 8, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 15, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2023

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
Last Updated

September 14, 2023

Status Verified

September 1, 2023

Enrollment Period

1.9 years

First QC Date

August 8, 2023

Last Update Submit

September 13, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • comparison between diagnostic yields of different tissue sampling techniques of bronchoscope in lung cancer diagnosis

    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

Study Arms (2)

bronchial wash group

ACTIVE COMPARATOR

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

Device: bronchoscope

bronchial brush

ACTIVE COMPARATOR

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

Device: bronchoscope

Interventions

bronchoscpe with broncial brush and biopsy or bronchial wash and biopsy

bronchial brushbronchial wash group

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients in whom clinical findings, radiological examination suggested lung malignancy. patients with chronic cough, hemoptysis and lymph node enlargement.

You may not qualify if:

  • patients with no evidence of malignancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 27076949BACKGROUND
  • 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.

    PMID: 31974454BACKGROUND

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Bronchoscopes

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

EndoscopesDiagnostic EquipmentEquipment and SuppliesSurgical Equipment

Central Study Contacts

manal ahmed

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Model Details: analytical cross sectional
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

August 8, 2023

First Posted

August 15, 2023

Study Start

October 1, 2023

Primary Completion

September 1, 2025

Study Completion

October 1, 2025

Last Updated

September 14, 2023

Record last verified: 2023-09