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

Recruiting

• Conditions: Liver Cirrhosis; Portal Hypertension; Gastroesophageal Varices
• Interventions: Diagnostic Test: Endoscopic ruler

• Registration Number: NCT04639323
• Lead Sponsor: Hepatopancreatobiliary Surgery Institute of Gansu Province

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-11-15
• Study First Submitted QC: 2020-11-19
• Study First Posted: 2020-11-20
• Study Start: 2020-12-23
• Status Verified: 2023-04
• Primary Completion: 2023-04-01
• Last Update Submitted: 2023-04-23
• Last Update Posted: 2023-04-25
• Study Completion: 2025-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 266

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Overall eligible participants	Endoscopic ruler	Eligible participants whose varix size will be measured by endoscopists and endoscopic ruler will receive standard esophagogastroduodenoscopy

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
The bleeding rate of endoscopic ruler	2020/11/13-2022/11/13
The timing of endoscopic ruler	2020/11/13-2022/11/13
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 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

Trial Locations

Locations (7)

People's Hospital of Ningxia Hui Autonomous Region; 🇨🇳 Yinchuan, China

Tianjin Second People's Hospital; 🇨🇳 Tianjin, China

The Second Affiliated Hospital of Baotou Medical College; 🇨🇳 Baotou, China

The Third Xiangya Hospital of Central South University; 🇨🇳 Changsha, China

The first hospital of Lanzhou university; 🇨🇳 Lanzhou, China

The Second Hospital of Hebei Medical University; 🇨🇳 Shijiazhuang, China

The First Affiliated Hospital with Nanjing Medical University; 🇨🇳 Nanjing, China