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

Liver Cirrhosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04639323
• Other study ID #: CHESS2005
• Status: Recruiting
• Start date: December 23, 2020
• Est. completion date: January 1, 2025

Study information

• Verified date: April 2023
• Source: Hepatopancreatobiliary Surgery Institute of Gansu Province
• Contact: Xiaolong Qi, M.D.
• Phone: +86 18588602600
• Email: qixiaolong[@]vip.163.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 266
• Est. completion date: January 1, 2025
• Est. primary completion date: April 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Gastroesophageal Varices
• Hypertension
• Hypertension, Portal
• Liver Cirrhosis
• Portal Hypertension

Intervention

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

Locations

Country	Name	City	State
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 First Affiliated Hospital with Nanjing Medical University	Nanjing
China	The Second Hospital of Hebei Medical University	Shijiazhuang
China	Tianjin Second People's Hospital	Tianjin
China	People's Hospital of Ningxia Hui Autonomous Region	Yinchuan

Sponsors (10)

Lead Sponsor

Collaborator

Hepatopancreatobiliary Surgery Institute of Gansu Province

First Hospital of China Medical University, LanZhou University, People's Hospital of Ningxia Hui Autonomous Region, The Affiliated Hospital Of Southwest Medical University, The First Affiliated Hospital with Nanjing Medical University, The Second Affiliated Hospital of Baotou Medical College, The Second Hospital of Hebei Medical University, The Third Xiangya Hospital of Central South University, Tianjin Second People's Hospital

Country where clinical trial is conducted

China, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

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