Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000518965
Ethics application status
Approved
Date submitted
18/02/2020
Date registered
27/04/2020
Date last updated
27/04/2020
Date data sharing statement initially provided
27/04/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Feasibility of thin disposable endoscopes for screening and surveillance of gastro-oesophageal varices performed in outpatient liver clinic
Scientific title
Feasibility of thin disposable endoscopes for screening and surveillance of gastro-oesophageal varices performed in outpatient liver clinic
Secondary ID [1] 300585 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record
This is a follow-up to study ACTRN12616001103459

Health condition
Health condition(s) or problem(s) studied:
Gastro-oesophageal varices 316321 0
Condition category
Condition code
Oral and Gastrointestinal 314588 314588 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
Patients with liver cirrhosis who are scheduled to attend RAH Liver Clinic will be screened 4 weeks prior to their attendance. Patients who are due for their surveillance gastroscopy for gastro-esophagal varices will be identified by their treating physician and will be sent a signed letter of invitation. Patients who are interested in participating will be able to contact the researchers using an opt-in form and reply paid envelope. If no response is received following the initial letter, a single follow-up phone call will be made to confirm the patient’s decision for opt-in or opt-out. A follow-up phone call will be made 24-48 hours prior to the scheduled appointment to confirm whether the patient is agreeable to study participation. Subjects who agree to participate in the study will be asked to fast six hours prior to their attendance at the Outpatient department. Once the subjects are seen by the caring physician and the need for surveillance gastroscopy is confirmed, the subjects will be consented and un-sedated disposable ultra-thin gastroscopy will be performed in a dedicated room in the Liver clinic by an endoscopist.

Procedure: The duration of the procedure is approximately 5-10 minutes. All subjects will be asked to complete the visual analogue scale for pain and State-trait Anxiety Inventory (STAI Y-1) score prior to commencement of the unsedated gastroscopy, which will be performed under laryngeal/pharyngeal local anaesthesia with lignocaine gargle or spray (10 minutes prior). On endoscopic examination, the following will be documented:
1. Number and location of varices: upper, middle or lower oesophagus or stomach.
2. Size of varices: classified according to Baveno I consensus, small varices < 5mm, large varices >5mm. [13]
3. Presence of red colour signs / red wale signs
4. Tolerability: to be assessed by pain visual analogue scale and State-trait Anxiety Inventory (STAI Y-1) form
5. Adverse events (3-min vital signs will be recorded).
Intervention code [1] 316891 0
Early detection / Screening
Intervention code [2] 317118 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 322917 0
Feasibility will be assessed by successful intubation of:
-the oesophagus

Assessed via audit of video recording.
Timepoint [1] 322917 0
Within 24 hours of procedure.
Primary outcome [2] 323224 0
Feasibility will be assessed by successful intubation of:
-the duodenum

Assessed via audit of video recording.
Timepoint [2] 323224 0
Within 24 hours of procedure.
Secondary outcome [1] 380239 0
tolerability

Assessed via visual analogue scale for pain and State-trait Anxiety Inventory (STAI Y-1) score.
Timepoint [1] 380239 0
Within 48 hours following procedure
Secondary outcome [2] 381226 0
adverse events/complication - Adverse events related to possible gastroscope trauma
after the endoscopies, including sore throat, hematemesis, melena or blood passed per rectum, and abdominal pain.

Assessed via participant self-reported and checking medical records.
Timepoint [2] 381226 0
Within 48 hours following procedure.

Eligibility
Key inclusion criteria
1. Male or female subject aged 18 – 90 years
2. Cirrhosis (of any aetiology) as documented by histology, or chronic liver disease with the presence of portal hypertension (eg. ascites, gastro-oesophageal varices) or complications of cirrhosis (eg. hepatic encephalopathy)
Minimum age
18 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Pregnant and/or breastfeeding mothers
2. As this a diagnostic study only, patients who will likely need endoscopic intervention including secondary prophylaxis with variceal banding are excluded
a. Presence of active gastrointestinal bleeding
b. History of recent variceal bleed within 7 days
3. Unable to give 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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
23/04/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
24
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 305007 0
Hospital
Name [1] 305007 0
Royal Adelaide Hospital
Country [1] 305007 0
Australia
Primary sponsor type
Hospital
Name
GI and Pancreatic Researchs Group, Royal Adelaide Hospital
Address
Department of Gastroenterology
Royal Adelaide Hospital
Port Road Adelaide SA 5000
Country
Australia
Secondary sponsor category [1] 305364 0
None
Name [1] 305364 0
Address [1] 305364 0
Country [1] 305364 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305404 0
Royal Adelaide Hospital Research Ethics Committee
Ethics committee address [1] 305404 0
CALHN Research Office
RAH Clinical Trial Centre
Level 3, Royal Adelaide Hospital
Port Road
ADELAIDE SA 5000
Ethics committee country [1] 305404 0
Australia
Date submitted for ethics approval [1] 305404 0
Approval date [1] 305404 0
22/02/2018
Ethics approval number [1] 305404 0

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 feasibility of performing this procedure in the outpatient clinic, using a new endoscope. The newer scope is very thin, disposable and can be used in a consultation room. The thinness of the scope allows the examination to be performed without sedation, using only local anaesthesia with lignocaine gargle or spray. The scope has already been shown to be as effective in the detection of large varices as standard endoscopy; this study aims to assess the viability of its use in the outpatient setting.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 100262 0
A/Prof Nam Q Nguyen
Address 100262 0
Department of Gastroenterology
Royal Adelaide Hospital
Port Road Adelaide SA 5000
Country 100262 0
Australia
Phone 100262 0
+61 8 70742189
Fax 100262 0
Email 100262 0
[email protected]
Contact person for public queries
Name 100263 0
Mrs Romina Safaeian
Address 100263 0
Department of Gastroenterology
Royal Adelaide Hospital
Port Road Adelaide SA 5000
Country 100263 0
Australia
Phone 100263 0
+61 8 70742189
Fax 100263 0
Email 100263 0
[email protected]
Contact person for scientific queries
Name 100264 0
Mrs Romina Safaeian
Address 100264 0
Department of Gastroenterology
Royal Adelaide Hospital
Port Road Adelaide SA 5000
Country 100264 0
Australia
Phone 100264 0
+61 8 70742189
Fax 100264 0
Email 100264 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.