NCT05569629Completed
Bronchial Washing Beforeand After Endobronchial Biopsy and Bronchial Brushing
Diagnostic Yield of Bronchial Washing Before and After Endobronchial Biopsy and Bronchial Brushing for Endoscopically Visible Tumours
Source: ClinicalTrials.gov · Last updated 20 Aug 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 118 (actual)
- First submitted
- 2 Oct 2022
- Start date
- 1 Oct 2022
- Primary completion date
- 30 Oct 2023
- Lead sponsor
- Chinese University of Hong Kong
- Diseases
- Lung cancer
- NCT number
- NCT05569629
What you commit to
- Study type: Interventional
- Participants enrolled: 118
- From 1 Oct 2022 to the primary completion date, 30 Oct 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Failed to obtain informed consent due to patient's refusal or cognitive impairment
- 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
- Excessive bleeding due to EBBx and BB causing difficult procedure of subsequent BW or premature termination of the procedure
Other
- Endoscopically visible tumours are not expected based on pre-bronchoscopy imaging (e.g. CT thorax)
- Bronchoscopy that will be performed in an emergency situation that precludes a detailed examination or prolonged procedure time, e.g. massive haemoptysis
- 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
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Chinese University of Hong Kong Coordinator of this site? Confirm its status | Hong Kong | Hong Kong SAR China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.