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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Liver Cirrhosis; Portal Hypertension; Gastroesophageal Varices
• Intervention / Treatment: Diagnostic test: Endoscopic ruler

• Study Type: Observational
• Enrollment (Anticipated): 266

Contacts and Locations

• Study Contact: Name: Yifei Huang, M.D.; Phone Number: +86 15800004518; Email: huangyf1995@foxmail.com

Study Locations

• China
  • Baotou, China
    • Not yet recruiting
    • The Second Affiliated Hospital of Baotou Medical College
    • Contact: Xianmei Meng, M.D.
  • Changsha, China
    • Not yet recruiting
    • The Third Xiangya Hospital of Central South University
    • Contact: Xiaoyan Wang, M.D.
  • Lanzhou, China
    • Not yet recruiting
    • The First Hospital of Lanzhou University
    • Contact: Xiaolong Qi, M.D.
  • Nanjing, China
    • Not yet recruiting
    • The First Affiliated Hospital with Nanjing Medical University
    • Contact: Guoxin Zhang, M.D.
  • Shijiazhuang, China
    • Not yet recruiting
    • The Second Hospital of Hebei Medical University
    • Contact: Zhijie Feng, M.D.
  • Tianjin, China
    • Not yet recruiting
    • Tianjin Second People's Hospital
    • Contact: Fengmei Wang, M.D.
  • Yinchuan, China
    • Recruiting
    • People's Hospital of Ningxia Hui Autonomous Region
    • Contact: Shengjuan Hu, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

The investigators prospectively recruit well-defined participants with liver cirrhosis from university hospitals. Esophagogastroduodenoscopy is performed by a dedicated endoscopist at each center. Varices size is evaluated by the endoscopist and endoscopic ruler.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Overall eligible participants; Eligible participants whose varix size will be measured by endoscopists and endoscopic ruler will receive standard esophagogastroduodenoscopy

Diagnostic test: Endoscopic ruler; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Hepatopancreatobiliary Surgery Institute of Gansu Province
• Collaborators: The First Affiliated Hospital with Nanjing Medical University; LanZhou University; The Second Hospital of Hebei Medical University; The Third Xiangya Hospital of Central South University; First Hospital of China Medical University; The Affiliated Hospital Of Southwest Medical University; The Second Affiliated Hospital of Baotou Medical College; Tianjin Second People's Hospital; People's Hospital of Ningxia Hui Autonomous Region

Publications and helpful links

General Publications

• Qi X, Berzigotti A, Cardenas A, Sarin SK. Emerging non-invasive approaches for diagnosis and monitoring of portal hypertension. Lancet Gastroenterol Hepatol. 2018 Oct;3(10):708-719. doi: 10.1016/S2468-1253(18)30232-2.
• Cremers I, Ribeiro S. Management of variceal and nonvariceal upper gastrointestinal bleeding in patients with cirrhosis. Therap Adv Gastroenterol. 2014 Sep;7(5):206-16. doi: 10.1177/1756283X14538688.
• Bendtsen F, Skovgaard LT, Sorensen TI, Matzen P. Agreement among multiple observers on endoscopic diagnosis of esophageal varices before bleeding. Hepatology. 1990 Mar;11(3):341-7. doi: 10.1002/hep.1840110302.
• Cales P, Pascal JP. Gastroesophageal endoscopic features in cirrhosis: comparison of intracenter and intercenter observer variability. Gastroenterology. 1990 Oct;99(4):1189. doi: 10.1016/0016-5085(90)90652-h. No abstract available.

Study record dates

Study Major Dates

• Study Start (Actual): December 23, 2020
• Primary Completion (Actual): April 1, 2023
• Study Completion (Anticipated): January 1, 2025

Study Registration Dates

• First Submitted: November 15, 2020
• First Submitted That Met QC Criteria: November 19, 2020
• First Posted (Actual): November 20, 2020

Study Record Updates

• Last Update Posted (Actual): April 25, 2023
• Last Update Submitted That Met QC Criteria: April 23, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Esophagogastroduodenoscopy; Endoscopic ruler; Varices size
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Liver Diseases; Fibrosis; Hypertension; Liver Cirrhosis; Hypertension, Portal
• Other Study ID Numbers: CHESS2005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No