Bronchial Washing Beforeand After Endobronchial Biopsy and Bronchial Brushing

NCT05569629 | Completed

• 1 other identifier: PrePostBW
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

Brief Summary

Objective: To identify the optimal position of bronchial washing (BW) in the sequence of bronchoscopic sampling in order to maximize the ability to confirm malignancy for endoscopically visible tumours. Hypothesis to be tested: The investigators hypothesize that the diagnostic yield, with the incorporation of contemporary cytology processing techniques, of combined BW before and after endobronchial biopsy (EBBx) / bronchial brushing (BB) is higher than that of single BW after EBBx / BB. Design and subjects: This is a prospective, randomized controlled study to be conducted in the medical department of a tertiary care hospital in Hong Kong involving patients who will receive bronchoscopy. Patients will be recruited if an endoscopically visible tumour is suspected. Study instruments: Patients will be randomized into two groups. The diagnostic yield of confirming malignancy for endoscopically visible tumours, with the incorporation of contemporary cytology processing techniques, will be compared between obtaining BW before and after EBBx / BB, and obtaining single BW after EBBx / BB. Main outcome measures: Only patients with a definite cytological or histological diagnosis of lung cancer will be included in further analyses. The diagnostic yield of diagnosing lung cancer between the pre \& post-EBBx/BB group and post-EBBx/BB group will be compared by the Chi-square test as an intergroup comparison.

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (1)

• To compare the diagnostic yield of bronchial washing in confirming malignancy (intergroup comparison)

  To compare the diagnostic yield of bronchial washing in confirming malignancy for endoscopically visible tumours between obtaining bronchial washing before and after endobronchial biopsy and bronchal brushing, and obtaining single bronchial washing after endobronchial biopsy and bronchal brushing

  18 months

Secondary Outcomes (4)

• To compare the diagnostic yield of bronchial washing in confirming malignancy (intragroup comparison)

  18 months

• To compare the cell adequacy in the bronchial washing cytology specimens

  18 months

• To compare the time spent for endoscopic sampling procedures

  18 months

• To compare the occurrence of bleeding complications during endoscopic sampling procedures

  18 months

Study Arms (2)

Pre & post-EBBx/BB group

EXPERIMENTAL

BW will be performed once before endobronchial biopsy and bronchial brushing, and once after endobronchial biopsy and bronchial brushing

Procedure: Bronchial washing before endobronchial biopsy and brushing

Post-EBBx/BB group

NO INTERVENTION

BW will be performed once after endobronchial biopsy and bronchial brushing

Interventions

Bronchial washing before endobronchial biopsy and brushing PROCEDURE

Bronchial washing: adding bronchial washing once to the standard endoscopic sampling sequence (endobronchial biopsy and brushing first, followed by bronchial washing once) in the experimental arm

Pre & post-EBBx/BB group

Eligibility Criteria

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

You may qualify if:

• Patients who are eligible for bronchoscopy and endoscopic sampling procedures (i.e. endobronchial biopsy (EBBx), bronchial brushing (BB) and bronchial washing (BW)) as recommended by the prevailing local guideline
• Patients will undergo endoscopic sampling procedures to the airway that contains the endoscopically visible tumours
• Patients who are aged 18 years old or above
• Patients are cognitively capable to consent for the procedure and the study
• Patients with endoscopically visible tumours in the airway during bronchoscopy, that can be approached by endoscopic sampling procedures
• Only those visible lesions with endoscopic morphology of tumorous, infiltrative, necrotic-coated types will be included

You may not qualify if:

• Endoscopically visible tumours are not expected based on pre-bronchoscopy imaging (e.g. CT thorax)
• Failed to obtain informed consent due to patient's refusal or cognitive impairment
• Bronchoscopy that will be performed in an emergency situation that precludes a detailed examination or prolonged procedure time, e.g. massive haemoptysis
• The prevailing contraindications for bronchoscopy or bronchoscopic samplings, e.g. uncorrected coagulopathy, and uncontrolled respiratory failure
• Lesions with an anticipated high risk of severe bleeding are found, e.g. carcinoid tumour, Dieulafoy's lesion and Kaposi sarcoma
• The targeted lesion is located in the trachea or carina
• Patients with tumours morphology of submucosal type or extrinsic compressions, or with a normal mucosal appearance in the targeted airway
• Technical reasons precluding an optimal sampling of the lesion by endoscopic sampling procedures, including sharp angulation of the airway and patient intolerance
• Excessive bleeding due to EBBx and BB causing difficult procedure of subsequent BW or premature termination of the procedure
• Coexisting tumours in the same lobar or segmental bronchi, either proximal or distal to the targeted lesion, as it is impossible to distinguish the source of exfoliated cells
• A total volume of more than 100mL of normal saline is instilled for the first BW in the combined BW group, as the total amount of normal saline after the two BW procedures may exceed 200mL and impose a risk of impaired gaseous exchange

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Chinese University of Hong Kong

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Toothbrushing

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Oral Hygiene; Preventive Dentistry; Dentistry

Study Officials

• David SC Hui, MD

  Chinese University of Hong Kong

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: All bronchial washing samples will be examined independently by two senior pathologists, who will be blinded to the sequence of bronchial washing and results of the other samples.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Lecturer

Study Record Dates

• First Submitted: October 2, 2022
• First Posted: October 6, 2022
• Study Start: October 1, 2022
• Primary Completion: October 30, 2023
• Study Completion: June 30, 2024
• Last Updated: August 20, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)