None listed
Conditions
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.
Interventions
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 sin
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).
Sponsors
GI and Pancreatic Researchs Group, Royal Adelaide Hospital
Study design
Allocation
Non-randomised trial
Primary purpose
Diagnosis
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Healthy volunteers
No
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)
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
Outcome results
None listed