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

NCT ID: NCT04639323

Last Updated: 2023-04-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

266 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-12-23

Study Completion Date

2025-01-01

Brief Summary

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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.

Detailed Description

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Conditions

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Liver Cirrhosis Portal Hypertension Gastroesophageal Varices

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Overall eligible participants

Eligible participants whose varix size will be measured by endoscopists and endoscopic ruler will receive standard esophagogastroduodenoscopy

Endoscopic ruler

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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LanZhou University

OTHER

Sponsor Role collaborator

Tianjin Second People's Hospital

OTHER

Sponsor Role collaborator

The First Affiliated Hospital with Nanjing Medical University

OTHER

Sponsor Role collaborator

People's Hospital of Ningxia Hui Autonomous Region

OTHER

Sponsor Role collaborator

The Second Affiliated Hospital of Baotou Medical College

OTHER

Sponsor Role collaborator

The Third Xiangya Hospital of Central South University

OTHER

Sponsor Role collaborator

The Second Hospital of Hebei Medical University

OTHER

Sponsor Role collaborator

The Affiliated Hospital Of Southwest Medical University

OTHER

Sponsor Role collaborator

First Hospital of China Medical University

OTHER

Sponsor Role collaborator

Hepatopancreatobiliary Surgery Institute of Gansu Province

OTHER

Sponsor Role lead

Responsible Party

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Xiaolong Qi

Director, Institute of Portal Hypertension

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Xiaolong Qi, M.D.

Role: STUDY_CHAIR

LanZhou University

Fengmei Wang, M.D.

Role: PRINCIPAL_INVESTIGATOR

Tianjin Second People's Hospital

Guoxin Zhang, M.D.

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital with Nanjing Medical University

Shengjuan Hu, M.D.

Role: PRINCIPAL_INVESTIGATOR

People's Hospital of Ningxia Hui Autonomous Region

Xianmei Meng, M.D.

Role: PRINCIPAL_INVESTIGATOR

The Second Affiliated Hospital of Baotou Medical College

Xiaoyan Wang, M.D.

Role: PRINCIPAL_INVESTIGATOR

The Third Xiangya Hospital of Central South University

Zhijie Feng, M.D.

Role: PRINCIPAL_INVESTIGATOR

The Second Hospital of Hebei Medical University

Muhan Lv, M.D.

Role: PRINCIPAL_INVESTIGATOR

The Affiliated Hospital Of Southwest Medical University

Yiling Li, M.D.

Role: PRINCIPAL_INVESTIGATOR

First Hospital of China Medical University

Locations

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The Second Affiliated Hospital of Baotou Medical College

Baotou, , China

Site Status NOT_YET_RECRUITING

The Third Xiangya Hospital of Central South University

Changsha, , China

Site Status NOT_YET_RECRUITING

The first hospital of Lanzhou university

Lanzhou, , China

Site Status NOT_YET_RECRUITING

The First Affiliated Hospital with Nanjing Medical University

Nanjing, , China

Site Status NOT_YET_RECRUITING

The Second Hospital of Hebei Medical University

Shijiazhuang, , China

Site Status NOT_YET_RECRUITING

Tianjin Second People's Hospital

Tianjin, , China

Site Status NOT_YET_RECRUITING

People's Hospital of Ningxia Hui Autonomous Region

Yinchuan, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xiaolong Qi, M.D.

Role: CONTACT

+86 18588602600

Yifei Huang, M.D.

Role: CONTACT

+86 15800004518

Facility Contacts

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Xianmei Meng, M.D.

Role: primary

Xiaoyan Wang, M.D.

Role: primary

Xiaolong Qi, M.D.

Role: primary

Guoxin Zhang, M.D.

Role: primary

Zhijie Feng, M.D.

Role: primary

Fengmei Wang, M.D.

Role: primary

Shengjuan Hu, M.D.

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 30215362 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25177367 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 2312048 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 2203663 (View on PubMed)

Other Identifiers

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CHESS2005

Identifier Type: -

Identifier Source: org_study_id

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