Endoscopic Ruler for the Assessment of Variceal Bleeding Risks (CHESS2005)

Study Overview
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Brief Summary
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The presence of varices is a serious complication of portal hypertension in liver disease. To prevent variceal haemorrhage, screening and surveillance aims to detect high-risk varices related to varices size and determine the need for primary prophylaxis. Varices size evaluated by endoscopists might not be perfect reference, influenced by experience and machine. Endoscopic ruler is a novel tool to measure the varices size under the endoscopy. The investigators aim to evaluate the bias of varices size between endoscopists and endoscopic ruler as the reference.

Official Title
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Endoscopic Ruler for the Assessment of Variceal Bleeding Risks in Portal Hypertension (CHESS2005): A Prospective Multicenter Trial

Conditions
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Liver Cirrhosis, Portal Hypertension, Gastroesophageal Varices

Intervention / Treatment
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* Diagnostic Test: Endoscopic ruler


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age between 18 and 75 years clinically evident or biopsy-confirmed cirrhosis Varices diagnosed by endoscopy written informed consent Exclusion Criteria: red sign Active upper gastrointestinal bleeding

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Overall eligible participants<br>Eligible participants whose varix size will be measured by endoscopists and endoscopic ruler will receive standard esophagogastroduodenoscopy | Diagnostic Test: Endoscopic ruler<br>* Endoscopic ruler for varices in portal hypertension Product uses: measuring the diameter of the veins under the endoscopy for the assessment of the risk of variceal haemorrhage in patients with portal hypertension Black and white measuring rule is highly recognizable under the endoscopy The width of each cell is 1 mm, and the measuring range is 0-10 mm With smooth edge, safe and reliable<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The intraclass correlation coefficient (ICC) of the varix size and the kappa value of the varices bleeding risk between endoscopists and endoscopic ruler |  | 2020/11/13-2022/11/13 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The ICC value of the varix size and the kappa value of the varices bleeding risk among endoscopists |  | 2020/11/13-2022/11/13 | 
| The bleeding rate of endoscopic ruler |  | 2020/11/13-2022/11/13 | 
| The timing of endoscopic ruler |  | 2020/11/13-2022/11/13 | 
| The correlation coefficient between varices size and hepatic venous pressure gradient |  | 2020/11/13-2022/11/13 | 
| The correlation coefficient between varices size and decompensated events |  | 2020/11/13-2022/11/13 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Esophagogastroduodenoscopy, Endoscopic ruler, Varices size