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Trial registered on ANZCTR


Registration number
ACTRN12609000580279
Ethics application status
Not yet submitted
Date submitted
8/07/2009
Date registered
14/07/2009
Date last updated
14/07/2009
Type of registration
Prospectively registered

Titles & IDs
Public title
Early Diagnosis of Acute Gastrointestinal Bleeding with PillCam ESO
Scientific title
In patients with acute gastrointestinal bleeding is capsule endoscopy as good as or better than upper gastrointestinal (GI) endoscopy at making a diagnosis
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gastrointestinal Bleeding 237183 0
Condition category
Condition code
Oral and Gastrointestinal 237508 237508 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
Capsule endoscopy - A Pillcamera is swallowed by the patient with a small sip of water. The patient wears a receiver belt on the abdomen. The pillcamera takes images and electronically sends them to the recorder worn by the patient. The study duration is for one hour. The belt is removed and the pillcamera is excreted by the patient in the stools.
This is a one off procedure for the purpose of the study.
Intervention code [1] 236890 0
Diagnosis / Prognosis
Comparator / control treatment
Gastroscopy - All patients will also have standard upper GI endoscopy which is the current test of choice. The patient is given intravenous sedation by an anaesthetist. After this the endoscopist inserts a standard video gastroscope down the throat to examine the oesophagus, stomach and duodenum. This is a one off procedure that is normally done as parts of the standard hospital management of patients with GI bleeding. The procedure takes about one hour.
Control group
Active

Outcomes
Primary outcome [1] 238319 0
Successful diagnosis - This will be determined by use of standard video upper GI endoscopy which allows direct visual examination of the upper GI lining. This will be compared with the images taken by the pill camera.
Timepoint [1] 238319 0
24 hrs after intervention commenced
Primary outcome [2] 238320 0
Rockall score - The Rockall risk scoring system is used to identify patients at risk of adverse outcome following acute upper gastrointestinal bleeding. Rockall et al. identified independent risk factors which were later shown to predict mortality accurately. The scoring system uses clinical criteria (increasing age, co-morbidity, shock) as well as endoscopic finding (diagnosis, stigmata of acute bleeding). It is named for Professor Tim Rockall, who was the main investigator and first author of the studies that led to its formulation. Total score is calculated by simple addition. A score less than 3 carries good prognosis but total score more than 8 carries high risk of mortality.
The variables that are measured include: Age, Shock, Comorbidity, Diagnosis and Evidence of bleeding.
Timepoint [2] 238320 0
48 hrs after intervention
Secondary outcome [1] 244710 0
comparison of rebleeding rate which will be assessed by reviewing the patient's medical record at 4 weeks from study enrolment to assess for evidence of readmission to teh hospital with GI bleeding and also by a telephone interview with the patient where they will be asked if they represented to any other hospital or doctor with recurrent GI bleeding.
Timepoint [1] 244710 0
4 weeks after intervention commenced

Eligibility
Key inclusion criteria
All patients presenting with acute GI bleeding
Patients 18 yrs or older
Patients able to give consent
Patients eligible and willing to undergo upper endoscopy and Pillcam ESO
Minimum age
18 Years
Maximum age
85 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Dysphagia
Zenker’s diverticulum
Pregnancy
Esophageal stricture
Gastric or intestinal obstruction
Multiple abdominal surgeries
Cognitive impairment
Patients with large volume frank haematemesis

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
Other
Other design features
All patients enrolled in the study will first receive the pill camera procedure and then the standard upper GI endoscopy.
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 237290 0
Self funded/Unfunded
Name [1] 237290 0
Address [1] 237290 0
Country [1] 237290 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Given Imaging Inc
Address
3950 Shackleford Road
Suite 500
Duluth, GA 30096-1852
Country
United States of America
Secondary sponsor category [1] 236773 0
None
Name [1] 236773 0
Address [1] 236773 0
Country [1] 236773 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 239384 0
Northern Health Human Research and Ethics Committee.
Ethics committee address [1] 239384 0
185 Cooper St Epping 3076 Victoria
Ethics committee country [1] 239384 0
Australia
Date submitted for ethics approval [1] 239384 0
20/07/2009
Approval date [1] 239384 0
Ethics approval number [1] 239384 0

Summary
Brief summary
A new simple method of looking at the upper digestive tract has been developed. This is a capsule that has a camera inside it called PillCam ESO. The aim of this study is to compare the diagnostic effectiveness of PillCam ESO endoscopy with standard endsocopy in people with gastrointestinal bleeding.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29865 0
Address 29865 0
Country 29865 0
Phone 29865 0
Fax 29865 0
Email 29865 0
Contact person for public queries
Name 13112 0
Paul Froomes
Address 13112 0
Department of Gastroenterology
The Northern Hospital
185 Cooper St Epping Victoria 3076
Country 13112 0
Australia
Phone 13112 0
+61 3 93313122
Fax 13112 0
+61 3 93313133
Email 13112 0
paul.froomes@bigpond.com
Contact person for scientific queries
Name 4040 0
paul Froomes
Address 4040 0
Department of Gastroenterology
The Northern Hospital
185 Cooper St Epping Victoria 3076
Country 4040 0
Australia
Phone 4040 0
+61 3 93313122
Fax 4040 0
+61 417 582311
Email 4040 0
paul.froomes@bigpond.com

No information has been provided regarding IPD availability
Summary results
No Results