NCT04123509

Brief Summary

Gastroesophageal varices are a complication of portal hypertension in cirrhosis.Endoscopy is an unsatisfactory screening test.In this prospective clinical study,we will enroll patients with cirrhosis of various causes, all of whom undergo laboratory tests, elastography, and serum proteomic differential protein testing, including liver elastography (LSM) and spleen elastography (SSM). Baveno VI or expanded BavenoVI criteria are validated by comparing patients' LSM, SSM, serum differential protein, platelet count, and EGD data to evaluate the clinical value of SSM and differential proteins in excluding cirrhosis of cirrhosis.At the same time, based on SSM and serum differential protein, a new predictive model of variceal varices will be established to evaluate the diagnostic value of SSM and differential protein for esophagogastric varices, and a non-invasive method for reliably predicting and evaluating cirrhosis with esophageal varices will be found.

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
616

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2019

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

April 9, 2019

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 7, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 11, 2019

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2021

Completed
Last Updated

October 11, 2019

Status Verified

August 1, 2019

Enrollment Period

1.7 years

First QC Date

October 7, 2019

Last Update Submit

October 9, 2019

Conditions

Gastroesophageal VaricesPortal Hypertension

Outcome Measures

Primary Outcomes (1)

  • high-risk esophageal varices

    Incidence of high-risk esophageal varices

    2 years

Secondary Outcomes (2)

  • bleeding event happen

    1 year

  • bleeding event happen

    2 years

Eligibility Criteria

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

Patients with cirrhosis of various etiologies

You may qualify if:

  • The age ranged from 18 to 75 years.
  • Clinical or pathological diagnosis of cirrhosis;
  • Electronic gastroscopy is planned;
  • To agree and sign the informed consent;

You may not qualify if:

  • Hepatocellular carcinoma or other malignant tumors have been or are currently diagnosed;
  • Orthotopic liver transplantation patients;
  • Patients who have undergone transjugular intrahepatic portosystemic shunt (TIPS),or previous surgical shunt;
  • Pregnant women;
  • Neurological or psychiatric disorders;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hepatology Unit, Department of Infectious Diseases, Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, 510515, China

RECRUITING

Related Publications (3)

  • Liu M, Zhang X, Cheng X, He Q, Zhou T, Wang H, Li B, Luo W, Li J, Li H, Lin Z, Song J, Wang W, Huang J, Ji Y, Zhou D, Xie W, Yang Q, Tu M, Luo X, Zhang X, Yan H, Chen J. Indocyanine Green Clearance Test via Pulse Dye Densitometry for Portal Hypertension Diagnosis in cACLD. Liver Int. 2025 Dec;45(12):e70425. doi: 10.1111/liv.70425.

    PMID: 41178521DERIVED

  • Sharma S, Agarwal S. Prospective validation of Baveno VI criteria in virally supressed HBV cirrhosis - more evidence is needed. J Hepatol. 2021 Mar;74(3):758-759. doi: 10.1016/j.jhep.2020.10.007. Epub 2021 Jan 19. No abstract available.

    PMID: 33353741DERIVED

  • Wang H, Wen B, Chang X, Wu Q, Wen W, Zhou F, Guo Y, Ji Y, Gu Y, Lai Q, He Q, Li J, Chen J, Hou J. Baveno VI criteria and spleen stiffness measurement rule out high-risk varices in virally suppressed HBV-related cirrhosis. J Hepatol. 2021 Mar;74(3):584-592. doi: 10.1016/j.jhep.2020.09.034. Epub 2020 Oct 8.

    PMID: 33039403DERIVED

MeSH Terms

Conditions

Hypertension, Portal

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System Diseases

Central Study Contacts

Jinjun Chen, PHD

CONTACT

8618588531001chjj@smu.edu.cn

Biao Wen

CONTACT

8613320961408jevine521219@outlook.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 7, 2019

First Posted

October 11, 2019

Study Start

April 9, 2019

Primary Completion

December 31, 2020

Study Completion

January 31, 2021

Last Updated

October 11, 2019

Record last verified: 2019-08

Locations

CN(1)