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Trial registered on ANZCTR


Registration number
ACTRN12616001103459
Ethics application status
Approved
Date submitted
2/08/2016
Date registered
15/08/2016
Date last updated
15/08/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Disposable gastroscope for variceal screening and surveillance
Scientific title
Ultra-thin disposable gastroscope for screening and surveillance of gastro-oesophageal varices in patients with liver cirrhosis: a prospective comparative study
Secondary ID [1] 289820 0
Nil Known
Universal Trial Number (UTN)
U1111-1185-9724
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Liver cirrhosis 299745 0
Portal hypertension 299746 0
Gastro-oesophageal varices 299799 0
Condition category
Condition code
Oral and Gastrointestinal 299678 299678 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
This is a pilot study that will prospectively evaluate the role of disposable thin endoscopy in screening and surveillance of gastro-oesohageal varices, compared to the current gold standard upper endoscopy.

Consecutive patients with liver cirrhosis scheduled to undergo upper endoscopy in the Gastrointestinal Investigation Unit for variceal screening or surveillance will be screened for eligibility to participate in the study. Patients will undergo examination with thin disposable endoscopy and standard upper endoscopy on the same day or within 72 hours. These 2 examinations will be performed by different consultant gastroenterologist who will be blinded to the results of the other endoscopic examination.

Upper endoscopy with the disposable ultra-thin gastroscope will be performed unsedated after a minimum of four hour fast from solids and liquids. The patients will receive laryngeal/pharyngeal local anesthesia with lignocaine gargle or spray. The patient will be in the left lateral position for the upper endoscope. The approximate duration of the procedure will be 15 minutes. This will be followed by conventional gastroscopy which will be performed under sedation. The approximate duration of this examination will be 15 minutes

On endoscopic examination, the following will be documented:
Number and location of varices: upper, middle or lower oesophagus or stomach.
Size of varices: classified according to Baveno I consensus, small varices < 5mm, large varices >5mm.
Presence of red colour signs / red wale signs
Intervention code [1] 295496 0
Early detection / Screening
Comparator / control treatment
Gold standard conventional gastroscopy
Control group
Active

Outcomes
Primary outcome [1] 299140 0
Accuracy of new device to detect the presence of oesophageal varices compared with CG results
Timepoint [1] 299140 0
End of endoscopic evaulation
Primary outcome [2] 299280 0
Accuracy of the new device to detect the presence of high risk varices compared with CG results
Timepoint [2] 299280 0
Completion of endoscopic evaluation
Secondary outcome [1] 326303 0
sensitivity for the detection of oesophageal varices and the presence of high risk varices compared with CG results
Timepoint [1] 326303 0
End of endoscopic evaluation
Secondary outcome [2] 326304 0
Specificity for the detection of oesophageal varices and the presence of high risk varices compared with CG results
Timepoint [2] 326304 0
End of endoscopic evaluation
Secondary outcome [3] 326305 0
Safety will be assessed with vital signs performed every 3 minutes and clinical assessment by the clinician during the procedure and the patient observed for 1 hour post procedure. A phone call will be made 24 hours after the procedure to document any late complications
Timepoint [3] 326305 0
At the time of endoscopic evaluation and upto 24 hours later
Secondary outcome [4] 326453 0
Postive predictive value for the detection of oesophageal varices and the presence of high risk varices compared with CG results
Timepoint [4] 326453 0
End of endoscopic evaluation
Secondary outcome [5] 326454 0
Negative predictive value for the detection of oesophageal varices and the presence of high rish varices compared with CG results
Timepoint [5] 326454 0
End of endoscopic evaluation

Eligibility
Key inclusion criteria
Liver cirrhosis
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Active gastrointestinal bleeding
Inability to provide written 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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
The sample size of 49 was caluclated for a specificity of 90%, with a prevalence of 0.3 in the target popultion and a margin of error of 0.10, with a 95% confidence interval.
Statistical analysis will be performed to calculate the sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy of thin disposable gastroscopy (TDG) compared with gold standard conventional gastroscopy(CG). The agreement between the presence or absence of varices and the grading of varices between TDG and CG will be assessed with calculation of kappa statistics. Inter-observer agreement for the assessment of presence and grade of varices will be calculated between the endoscopist and independent validator. The Mann Whitney U test ill be used to compare patient tolerability pre- and post-procedure, p<0.05 would be considered significant

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
2/09/2013
Date of last participant enrolment
Anticipated
Actual
28/11/2014
Date of last data collection
Anticipated
28/11/2015
Actual
28/11/2015
Sample size
Target
49
Accrual to date
Final
48
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 6350 0
The Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 13893 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 294204 0
Hospital
Name [1] 294204 0
The Royal Adelaide Hospital
Country [1] 294204 0
Australia
Primary sponsor type
Hospital
Name
The Royal Adelaide Hosptial
Address
North Terrace, Adelaide, SA 5000
Country
Australia
Secondary sponsor category [1] 293037 0
None
Name [1] 293037 0
None
Address [1] 293037 0
None
Country [1] 293037 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295612 0
Royal Adelaide Hospital Research Ethics Committee
Ethics committee address [1] 295612 0
North Terrace, Adelaide, SA 5000
Ethics committee country [1] 295612 0
Australia
Date submitted for ethics approval [1] 295612 0
29/06/2013
Approval date [1] 295612 0
02/07/2013
Ethics approval number [1] 295612 0
130230

Summary
Brief summary
Patients with liver cirrhosis are at risk of having varices (dilated vessels) in their oesophagus and stomach. These varices can bleed and bleeding is associated with serious complications. It is recommended that all patients have their oesophagus examined with an endoscopy (flexible telescope / camera) to detect these varices. Currently these endoscopies are performed in the Gastrointestinal Investigation Unit using sedation (medication to make you drowsy). The purpose of this study is to evaluate the accuracy of a new endoscope in detecting dilated vessel in the oesophagus and stomach compared to standard the endoscopy. The newer scope is very thin, disposable and can be performed in a consultation room. The thinness of the scope allows the examination to be performed without sedation, using only local sedation.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 67938 0
Dr Dep Huynh
Address 67938 0
Department of Gastroenterology and Hepatology
Royal Adelaide Hospital
North Terrace
Adelaide, SA 5000
Country 67938 0
Australia
Phone 67938 0
+61 8 8222 5214
Fax 67938 0
Email 67938 0
[email protected]
Contact person for public queries
Name 67939 0
Dep Huynh
Address 67939 0
Department of Gastroenterology and Hepatology
Royal Adelaide Hospital
North Terrace
Adelaide, SA 5000
Country 67939 0
Australia
Phone 67939 0
+61 8 8222 5214
Fax 67939 0
Email 67939 0
[email protected]
Contact person for scientific queries
Name 67940 0
Dep Huynh
Address 67940 0
Department of Gastroenterology and Hepatology
Royal Adelaide Hospital
North Terrace
Adelaide, SA 5000
Country 67940 0
Australia
Phone 67940 0
+61 8 8222 5214
Fax 67940 0
Email 67940 0
[email protected]

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
SourceTitleYear of PublicationDOI
EmbaseUltrathin disposable gastroscope for screening and surveillance of gastroesophageal varices in patients with liver cirrhosis: a prospective comparative study.2017https://dx.doi.org/10.1016/j.gie.2016.11.019
N.B. These documents automatically identified may not have been verified by the study sponsor.