NCT05569629Befejeződött
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
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2024. aug. 20.
Rövid összefoglaló (regiszter, angolul)
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.
- Állapot (regiszter)
- Befejeződött
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 118 (tényleges)
- Első benyújtás
- 2022. okt. 2.
- Kezdés
- 2022. okt. 1.
- Elsődleges befejezés
- 2023. okt. 30.
- Fő szponzor
- Chinese University of Hong Kong
- Betegségek
- Tüdőrák
- NCT-szám
- NCT05569629
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Bevont résztvevők: 118
- 2022. okt. 1. és az elsődleges befejezés (2023. okt. 30.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
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Ki nem vehet részt
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Más betegség
- 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
Egyéb
- 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
Kiket keres a vizsgálat
- 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
Életkor a regiszterben: 18 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Chinese University of Hong Kong | Hong Kong | Hongkong | Ismeretlen állapot |
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.