RecruitingACTRN12620000518965

Feasibility of thin disposable endoscopes for screening and surveillance of gastro-oesophageal varices performed in outpatient liver clinic


Sponsor

GI and Pancreatic Researchs Group, Royal Adelaide Hospital

Enrollment

30 participants

Start Date

Apr 23, 2018

Study Type

Interventional

Conditions

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.


Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 90 Yearss

Plain Language Summary

Simplified for easier understanding

People with liver cirrhosis (scarring of the liver from any cause) often develop enlarged veins called varices in the oesophagus and stomach. These varices can rupture and bleed heavily, which is a serious and potentially life-threatening complication. Current guidelines recommend that all cirrhosis patients have their oesophagus examined by endoscopy (a camera scope passed down the throat) to detect these varices. Traditionally, this procedure requires a hospital visit, sedation, and specialist equipment. This study is evaluating whether a much thinner, disposable endoscope can perform the same examination in a regular clinic room, without sedation — using only a local throat spray for comfort. This approach would make monitoring much more convenient and accessible for patients. You may be eligible if you are between 18 and 90 years old and have been diagnosed with liver cirrhosis or chronic liver disease with signs of portal hypertension. You are not eligible if you are pregnant or breastfeeding, if you have had a variceal bleed in the past week, or if you have active gastrointestinal bleeding that would require immediate treatment.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

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-esopha

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).


Locations(1)

SA, Australia

View Full Details on ANZCTR

For the most up-to-date information, visit the official listing.

Visit

ACTRN12620000518965