Condition category
Cancer
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
15/04/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Ms Ramita Dey

ORCID ID

Contact details

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

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

http://www.doh.gov.uk

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

Publication citations

Additional files

Editorial Notes