NCT04639323

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
266

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2020

Longer than P75 for all trials

Geographic Reach
1 country

7 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 15, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 20, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

December 23, 2020

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2023

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
Last Updated

April 25, 2023

Status Verified

April 1, 2023

Enrollment Period

2.3 years

First QC Date

November 15, 2020

Last Update Submit

April 23, 2023

Conditions

Liver CirrhosisPortal HypertensionGastroesophageal Varices

Keywords

EsophagogastroduodenoscopyEndoscopic rulerVarices size

Outcome Measures

Primary Outcomes (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 Outcomes (5)

  • The ICC value of the varix size and the kappa value of the varices bleeding risk among endoscopists

    2020/11/13-2022/11/13

  • The bleeding rate of endoscopic ruler

    2020/11/13-2022/11/13

  • The timing of endoscopic ruler

    2020/11/13-2022/11/13

  • The correlation coefficient between varices size and hepatic venous pressure gradient

    2020/11/13-2022/11/13

  • The correlation coefficient between varices size and decompensated events

    2020/11/13-2022/11/13

Study Arms (1)

Overall eligible participants

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

Diagnostic Test: Endoscopic ruler

Interventions

Endoscopic rulerDIAGNOSTIC_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

Overall eligible participants

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • age between 18 and 75 years
  • clinically evident or biopsy-confirmed cirrhosis
  • Varices diagnosed by endoscopy
  • written informed consent

You may not qualify if:

  • red sign
  • Active upper gastrointestinal bleeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

The Second Affiliated Hospital of Baotou Medical College

Baotou, China

NOT YET RECRUITING

The Third Xiangya Hospital of Central South University

Changsha, China

NOT YET RECRUITING

The first hospital of Lanzhou university

Lanzhou, China

NOT YET RECRUITING

The First Affiliated Hospital with Nanjing Medical University

Nanjing, China

NOT YET RECRUITING

The Second Hospital of Hebei Medical University

Shijiazhuang, China

NOT YET RECRUITING

Tianjin Second People's Hospital

Tianjin, China

NOT YET RECRUITING

People's Hospital of Ningxia Hui Autonomous Region

Yinchuan, China

RECRUITING

Related Publications (4)

  • 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.

    PMID: 30215362BACKGROUND

  • 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.

    PMID: 25177367BACKGROUND

  • 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.

    PMID: 2312048BACKGROUND

  • 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.

    PMID: 2203663BACKGROUND

MeSH Terms

Conditions

Liver CirrhosisHypertension, Portal

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Xiaolong Qi, M.D.

    LanZhou University

    STUDY CHAIR

  • 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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaolong Qi, M.D.

CONTACT

+86 18588602600qixiaolong@vip.163.com

Yifei Huang, M.D.

CONTACT

+86 15800004518huangyf1995@foxmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
7 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Institute of Portal Hypertension

Study Record Dates

First Submitted

November 15, 2020

First Posted

November 20, 2020

Study Start

December 23, 2020

Primary Completion

April 1, 2023

Study Completion

January 1, 2025

Last Updated

April 25, 2023

Record last verified: 2023-04

Locations

CN(7)