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

• Sponsor: Hepatopancreatobiliary Surgery Institute of Gansu Province (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04639323
• Collaborator: LanZhou University (Other), Tianjin Second People's Hospital (Other), The First Affiliated Hospital with Nanjing Medical University (Other), People's Hospital of Ningxia Hui Autonomous Region (Other), The Second Affiliated Hospital of Baotou Medical College (Other), The Third Xiangya Hospital of Central South University (Other), The Second Hospital of Hebei Medical University (Other), The Affiliated Hospital Of Southwest Medical University (Other), First Hospital of China Medical University (Other)
• Enrollment: 266
• Locations: 7
• Anticipated Duration (Months): 22.7
• Patients Per Site: 38
• Patients Per Site Per Month: 1.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Liver Cirrhosis; Portal Hypertension; Gastroesophageal Varices	Diagnostic Test: Endoscopic ruler

Study Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 266 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Endoscopic Ruler for the Assessment of Variceal Bleeding Risks in Portal Hypertension (CHESS2005): A Prospective Multicenter Trial
• Actual Study Start Date: Dec 23, 2020
• Anticipated Primary Completion Date: Nov 13, 2021
• Anticipated Study Completion Date: Nov 13, 2022

Arms and Interventions

Arm

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

Outcome Measures

Primary Outcome Measures

1. 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

1. The ICC value of the varix size and the kappa value of the varices bleeding risk among endoscopists [2020/11/13-2022/11/13]

2. The bleeding rate of endoscopic ruler [2020/11/13-2022/11/13]

3. The timing of endoscopic ruler [2020/11/13-2022/11/13]

4. The correlation coefficient between varices size and hepatic venous pressure gradient [2020/11/13-2022/11/13]

5. The correlation coefficient between varices size and decompensated events [2020/11/13-2022/11/13]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Second Affiliated Hospital of Baotou Medical College	Baotou		China
2	The Third Xiangya Hospital of Central South University	Changsha		China
3	The first hospital of Lanzhou university	Lanzhou		China
4	The First Affiliated Hospital with Nanjing Medical University	Nanjing		China
5	The Second Hospital of Hebei Medical University	Shijiazhuang		China
6	Tianjin Second People's Hospital	Tianjin		China
7	People's Hospital of Ningxia Hui Autonomous Region	Yinchuan		China

Sponsors and Collaborators

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

Investigators

• Study Chair: Xiaolong Qi, M.D., LanZhou University
• Principal Investigator: Fengmei Wang, M.D., Tianjin Second People's Hospital
• Principal Investigator: Guoxin Zhang, M.D., The First Affiliated Hospital with Nanjing Medical University
• Principal Investigator: Shengjuan Hu, M.D., People's Hospital of Ningxia Hui Autonomous Region
• Principal Investigator: Xianmei Meng, M.D., The Second Affiliated Hospital of Baotou Medical College
• Principal Investigator: Xiaoyan Wang, M.D., The Third Xiangya Hospital of Central South University
• Principal Investigator: Zhijie Feng, M.D., The Second Hospital of Hebei Medical University
• Principal Investigator: Muhan Lv, M.D., The Affiliated Hospital Of Southwest Medical University
• Principal Investigator: Yiling Li, M.D., First Hospital of China Medical University

Study Documents (Full-Text)

None provided.

More Information

Publications

• Bendtsen F, Skovgaard LT, Sørensen TI, Matzen P. Agreement among multiple observers on endoscopic diagnosis of esophageal varices before bleeding. Hepatology. 1990 Mar;11(3):341-7.
• Cales P, Pascal JP. Gastroesophageal endoscopic features in cirrhosis: comparison of intracenter and intercenter observer variability. Gastroenterology. 1990 Oct;99(4):1189.
• 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. Review.
• 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. Review.

• Responsible Party: Xiaolong Qi, Director, Institute of Portal Hypertension, Hepatopancreatobiliary Surgery Institute of Gansu Province
• ClinicalTrials.gov Identifier: NCT04639323
• Other Study ID Numbers: CHESS2005
• First Posted: Nov 20, 2020
• Last Update Posted: Aug 20, 2021
• Last Verified: Aug 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Xiaolong Qi, Director, Institute of Portal Hypertension, Hepatopancreatobiliary Surgery Institute of Gansu Province: Esophagogastroduodenoscopy; Endoscopic ruler; Varices size
• Additional relevant MeSH terms: Liver Cirrhosis; Hypertension, Portal; Hypertension

Study Results

No Results Posted as of Aug 20, 2021