The use of fibreoptic bronchoscopy in improving the outcome of surgery in patients with upper gastrointestinal (GI) cancer

ISRCTN	ISRCTN11257300
DOI	https://doi.org/10.1186/ISRCTN11257300
Secondary identifying numbers	N0025121734

Submission date: 12/09/2003
Registration date: 12/09/2003
Last edited: 15/04/2015

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Ms Ramita Dey
Scientific

General Surgery
University Hospital Aintree
Longmoor Lane
Liverpool
L9 7AL
United Kingdom

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title	The use of fibreoptic bronchoscopy in improving the outcome of surgery in patients with upper gastrointestinal (GI) cancer
Study objectives	The use of fibreoptic bronchoscopy in improving the outcome of surgery in patients with upper GI cancer
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure	Not provided at time of registration
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/03/2003
Completion date	01/03/2005

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Not Specified
Target number of participants	80
Key inclusion criteria	80 adult patients with upper GI cancer
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/03/2003
Date of final enrolment	01/03/2005

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

University Hospital Aintree

Liverpool
L9 7AL
United Kingdom

Sponsor information

Department of Health (UK)
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website	http://www.doh.gov.uk

Funders

Funder type

Government

Aintree Hospitals NHS Trust (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan