Clinical trial NCT04639323: Endoscopic Ruler for the Assessment of Variceal Bleeding Risks (CHESS2005)
Official title: Endoscopic Ruler for the Assessment of Variceal Bleeding Risks in Portal Hypertension (CHESS2005): A Prospective Multicenter Trial
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Liver Cirrhosis
Portal Hypertension
Gastroesophageal Varices
Keywords: Esophagogastroduodenoscopy
Endoscopic ruler
Varices size
Lead sponsor: Hepatopancreatobiliary Surgery Institute of Gansu Province
Sponsor class: OTHER
Collaborators: name: LanZhou University
name: Tianjin Second People's Hospital
name: The First Affiliated Hospital with Nanjing Medical University
name: People's Hospital of Ningxia Hui Autonomous Region
name: The Second Affiliated Hospital of Baotou Medical College
name: The Third Xiangya Hospital of Central South University
name: The Second Hospital of Hebei Medical University
name: The Affiliated Hospital Of Southwest Medical University
name: First Hospital of China Medical University
First posted: 2020-11-20
Enrollment: 266
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: The intraclass correlation coefficient (ICC) of the varix size and the kappa value of the varices bleeding risk between endoscopists and endoscopic ruler
timeFrame: 2020/11/13-2022/11/13
Secondary outcomes:
measure: The ICC value of the varix size and the kappa value of the varices bleeding risk among endoscopists
timeFrame: 2020/11/13-2022/11/13
measure: The bleeding rate of endoscopic ruler
timeFrame: 2020/11/13-2022/11/13
measure: The timing of endoscopic ruler
timeFrame: 2020/11/13-2022/11/13
measure: The correlation coefficient between varices size and hepatic venous pressure gradient
timeFrame: 2020/11/13-2022/11/13
measure: The correlation coefficient between varices size and decompensated events
timeFrame: 2020/11/13-2022/11/13
Other outcomes:
Locations:
city: Baotou
country: China
facility: The Second Affiliated Hospital of Baotou Medical College
city: Changsha
country: China
facility: The Third Xiangya Hospital of Central South University
city: Lanzhou
country: China
facility: The first hospital of Lanzhou university
city: Nanjing
country: China
facility: The First Affiliated Hospital with Nanjing Medical University
city: Shijiazhuang
country: China
facility: The Second Hospital of Hebei Medical University
city: Tianjin
country: China
facility: Tianjin Second People's Hospital
city: Yinchuan
country: China
facility: People's Hospital of Ningxia Hui Autonomous Region
Study officials:
affiliation: LanZhou University
name: Xiaolong Qi, M.D.
role: STUDY_CHAIR
affiliation: Tianjin Second People's Hospital
name: Fengmei Wang, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Affiliated Hospital with Nanjing Medical University
name: Guoxin Zhang, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: People's Hospital of Ningxia Hui Autonomous Region
name: Shengjuan Hu, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: The Second Affiliated Hospital of Baotou Medical College
name: Xianmei Meng, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: The Third Xiangya Hospital of Central South University
name: Xiaoyan Wang, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: The Second Hospital of Hebei Medical University
name: Zhijie Feng, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: The Affiliated Hospital Of Southwest Medical University
name: Muhan Lv, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: First Hospital of China Medical University
name: Yiling Li, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: 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.
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.