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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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04639323
Enrollment
266
Registered
2020-11-20
Start date
2020-12-23
Completion date
2025-01-01
Last updated
2023-04-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastroesophageal Varices, Liver Cirrhosis, Portal Hypertension

Keywords

Esophagogastroduodenoscopy, Endoscopic ruler, Varices size

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.

Interventions

DIAGNOSTIC_TESTEndoscopic 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

Sponsors

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

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
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

Design outcomes

Primary

MeasureTime frame
The intraclass correlation coefficient (ICC) of the varix size and the kappa value of the varices bleeding risk between endoscopists and endoscopic ruler2020/11/13-2022/11/13

Secondary

MeasureTime frame
The ICC value of the varix size and the kappa value of the varices bleeding risk among endoscopists2020/11/13-2022/11/13
The bleeding rate of endoscopic ruler2020/11/13-2022/11/13
The timing of endoscopic ruler2020/11/13-2022/11/13
The correlation coefficient between varices size and hepatic venous pressure gradient2020/11/13-2022/11/13
The correlation coefficient between varices size and decompensated events2020/11/13-2022/11/13

Countries

China

Contacts

Primary ContactXiaolong Qi, M.D.
qixiaolong@vip.163.com+86 18588602600
Backup ContactYifei Huang, M.D.
huangyf1995@foxmail.com+86 15800004518

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026