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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04639323
Other study ID # CHESS2005
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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