Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000867291
Ethics application status
Approved
Date submitted
27/07/2009
Date registered
6/10/2009
Date last updated
10/12/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Upper Gastrointestinal Capsule Endoscopy as a Tool for the Triage of Haematemasis and Melaena
Scientific title
An open labelled, single arm and single blinded study of the diagnostic utility of capsule endoscopy over standard endoscopy for the diagnosis of upper gastrointestinal haemorrhage.
Secondary ID [1] 252554 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute upper gastrointestinal haemorrhage. 237353 0
Condition category
Condition code
Oral and Gastrointestinal 239675 239675 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Study participants will swallow a capsule endoscope specifically designed to view the oesophagus and upper gastrointestinal tract. Images are transmitted wirelessly to a data recorder worn by the patient. The procedure is expected to take 2 hours. The capsule passes naturally through the bowel and is usually excreted in a bowel motion after 24 to 48 hours.

All patients will have a gastroscopy which is current standard treatment. Gastroscopy takes 15 minutes to perform. This will occur at least 2 hours after capsule ingestion.
Intervention code [1] 237013 0
Diagnosis / Prognosis
Comparator / control treatment
No control treatment
Control group
Uncontrolled

Outcomes
Primary outcome [1] 240447 0
The success of capsule endoscopy in diagnosing (or excluding) causes of upper gastrointestinal bleeding.

Images obtained by the capsule endoscopy will be interpreted by two gastroenterologist blinded to the results of the gastroscopy. Consensus agreement will be made if there are major discrepancies between the two reports. The results of capsule endoscopy will be directly compared to the results and diagnosis obtained during the gastroscopy. A standardise reporting sheet will be used for all procedures.
Timepoint [1] 240447 0
24 hours after intervention
Primary outcome [2] 240448 0
Correlation of findings seen on capsule endoscopy compared to gastroscopy.

This will be assessed using reports optained after visual examination of the images taken by both methods.
Timepoint [2] 240448 0
24 hours after intervention
Secondary outcome [1] 244958 0
Compare the patient tolerability and satisfaction between the procedures.

This will be assed by using a patient questionnaire and use of a visual analogue scale.
Timepoint [1] 244958 0
48 hours after intervention
Secondary outcome [2] 244959 0
Safety of upper gastrointestinal capsule endoscopy in the setting of acute gastrointestinal haemorrhage.

Assessment will include adverse events related to adminstration of the capsule. The main adverse event expected is capsule retention within the bowel.

Adverse events will be assessed by direct contact witht he patient at day 14. Where it is not clear that the capsule has passed, an abdominal xray will be performed.
Timepoint [2] 244959 0
14 days after intervention

Eligibility
Key inclusion criteria
All male and female patients 18 years or older admitted to the Alfred Hospital with symptoms and signs of upper gastrointestinal haemorrhage AND the patient requires an urgent gastroscopy (within 24hrs) for standard of care.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Any significant condition that would make capsule endoscopy inappropriate including unstable medical conditions, the need for urgent surgery or immediate gastroscopy; Known or suspected obstructions or strictures in the gastrointestinal tract, including Crohn’s disease, significant prior abdominal surgery (excluding appendicectomy or cholecystectomy) or abdominal/ pelvic radiotherapy; Clinically significant dysphagia or a swallowing disorder; Excessive non-steroidal anti-inflammatory drug use; Known or suspected pregnancy or breast feeding; Inability to follow instructions; The need for magnetic resonance imaging within a week of capsule ingestion; The patient cannot give informed consent.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Investigators reporting the capsule endoscopy will be blinded to the results of the gastroscopy.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/10/2009
Actual
1/10/2009
Date of last participant enrolment
Anticipated
Actual
1/10/2011
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 237402 0
Hospital
Name [1] 237402 0
The Alfred, Department of Gastroenterology research fund
Country [1] 237402 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Given Imaging, Ltd
Address
2 Hacarmel St.
New Industrial Park
POB 258
Yoqneam 20692
Country
Israel
Secondary sponsor category [1] 236899 0
None
Name [1] 236899 0
Address [1] 236899 0
Country [1] 236899 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239528 0
Alfred Hospital Ethics Committee (EC00315)
Ethics committee address [1] 239528 0
Ethics committee country [1] 239528 0
Australia
Date submitted for ethics approval [1] 239528 0
27/07/2009
Approval date [1] 239528 0
07/09/2009
Ethics approval number [1] 239528 0
272/09

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29964 0
Dr Paul Frooms
Address 29964 0
Austin Hospital
145 Studley Road
Heidelberg,
Victoria,
Australia, 3084
Country 29964 0
Australia
Phone 29964 0
+613 9496 5000
Fax 29964 0
Email 29964 0
pfroomes@me.com
Contact person for public queries
Name 13211 0
Dr Richard La Nauze
Address 13211 0
Department of Gastroenterology and Hepatology
The Alfred
PO Box 315
Prahran
Victoria
3181
Country 13211 0
Australia
Phone 13211 0
+613 9076 2000
Fax 13211 0
Email 13211 0
r.lanauze@alfred.org.au
Contact person for scientific queries
Name 4139 0
Dr Richard La Nauze
Address 4139 0
Department of Gastroenterology and Hepatology
The Alfred
PO Box 315
Prahran
Victoria
3181
Country 4139 0
Australia
Phone 4139 0
+613 9076 2000
Fax 4139 0
Email 4139 0
r.lanauze@alfred.org.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.