ANZCTR - Registration

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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]

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

Portal hypertension

Gastro-oesophageal varices

Condition category

Condition code

Oral and Gastrointestinal

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]

Early detection / Screening

Comparator / control treatment

Gold standard conventional gastroscopy

Control group

Active

Outcomes

Primary outcome [1]

Accuracy of new device to detect the presence of oesophageal varices compared with CG results

Timepoint [1]

End of endoscopic evaulation

Primary outcome [2]

Accuracy of the new device to detect the presence of high risk varices compared with CG results

Timepoint [2]

Completion of endoscopic evaluation

Secondary outcome [1]

sensitivity for the detection of oesophageal varices and the presence of high risk varices compared with CG results

Timepoint [1]

End of endoscopic evaluation

Secondary outcome [2]

Specificity for the detection of oesophageal varices and the presence of high risk varices compared with CG results

Timepoint [2]

End of endoscopic evaluation

Secondary outcome [3]

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]

At the time of endoscopic evaluation and upto 24 hours later

Secondary outcome [4]

Postive predictive value for the detection of oesophageal varices and the presence of high risk varices compared with CG results

Timepoint [4]

End of endoscopic evaluation

Secondary outcome [5]

Negative predictive value for the detection of oesophageal varices and the presence of high rish varices compared with CG results

Timepoint [5]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment hospital [1]

The Royal Adelaide Hospital - Adelaide

Recruitment postcode(s) [1]

5000 - Adelaide

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

The Royal Adelaide Hospital

Address [1]

North Terrace, Adelaide, SA 5000

Country [1]

Australia

Primary sponsor type

Hospital

Name

The Royal Adelaide Hosptial

Address

North Terrace, Adelaide, SA 5000

Country

Australia

Secondary sponsor category [1]

None

Name [1]

None

Address [1]

None

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Royal Adelaide Hospital Research Ethics Committee

Ethics committee address [1]

North Terrace, Adelaide, SA 5000

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

29/06/2013

Approval date [1]

02/07/2013

Ethics approval number [1]

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

Dr Dep Huynh

Address

Department of Gastroenterology and Hepatology
Royal Adelaide Hospital
North Terrace
Adelaide, SA 5000

Country

Australia

Phone

+61 8 8222 5214

Fax

dep.huynh@sa.gov.au

Contact person for public queries

Name

Dep Huynh

Address

Department of Gastroenterology and Hepatology
Royal Adelaide Hospital
North Terrace
Adelaide, SA 5000

Country

Australia

Phone

+61 8 8222 5214

Fax

dep.huynh@sa.gov.au

Contact person for scientific queries

Name

Dep Huynh

Address

Department of Gastroenterology and Hepatology
Royal Adelaide Hospital
North Terrace
Adelaide, SA 5000

Country

Australia

Phone

+61 8 8222 5214

Fax

dep.huynh@sa.gov.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

Source	Title	Year of Publication	DOI
Embase	Ultrathin disposable gastroscope for screening and surveillance of gastroesophageal varices in patients with liver cirrhosis: a prospective comparative study.	2017	https://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.

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Documents added manually

Documents added automatically