Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0025121734
Study information
Scientific title
The use of fibreoptic bronchoscopy in improving the outcome of surgery in patients with upper gastrointestinal (GI) cancer
Acronym
Study hypothesis
The use of fibreoptic bronchoscopy in improving the outcome of surgery in patients with upper GI cancer
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Cancer: Gastrointestinal
Intervention
Group 1: Postoperative awake flexible bronchoscopy will be carried out on ITU on days 1 and 2. Continuous monitoring of respiratory rate, heart rate, peripheral blood oxygen saturation and arterial blood pressure will be carried out during bronchoscopy. Equipment and expertise for endotracheal intubation will be available and used if patients experience significant deterioration in cardiovascular or respiratory function during procedure. All major and segmental bronchi will be inspected, toileting will be performed with suction and lavage. Protected brudh samples taken for microbiology and semiquantitative analysis of specimens performed. In case of extensive secretions bronchoscopy will be repeated after day 2 as required. During procedure incidence of early postextubation injury to larynx, incidence of iatrogenic trauma to distal airways and recurrent laryngeal nerve injury also assessed. Photographs recorded during bronchoscopy. Postprocedure lung function - forced expiratory volume in one second (FEV1)/forced vital capacity (FVC) ratio and peak flow will be assessed by spirometry and peak flow meter on days 1, 3, 5 and 8. Arterial blood gas analysis done days 1, 3 and 5. Temperature recorded daily. White cell count recorded days 1, 3 and 5.
Group 2: Best conventional treatment including epidural analgesia, humidified oxygen by mask and regular physiotherapy to clear secretions. Bronchoscopy will be undertaken in controlled subjects if clinically indicated.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/03/2003
Overall trial end date
01/03/2005
Reason abandoned
Eligibility
Participant inclusion criteria
80 adult patients with upper GI cancer
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
80
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/03/2003
Recruitment end date
01/03/2005
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University Hospital Aintree
Liverpool
L9 7AL
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Aintree Hospitals NHS Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary