Last reviewed · How we verify

NCT04123509

Non-invasive Method for Predicting the Presence of Gastroesophageal Varices in Patients With Cirrhosis

Status unknown Last updated 11 October 2019
What this trial tests

trial in Gastroesophageal Varices in 616 participants. Status unknown.

Timeline
9 April 2019
Primary endpoint
31 December 2020
31 January 2021

Quick facts

Lead sponsorNanfang Hospital, Southern Medical University
StatusStatus unknown
Study typeOBSERVATIONAL
Enrollment616
Start date9 April 2019
Primary completion31 December 2020
Estimated completion31 January 2021
Sites1 location across China

Conditions studied

Sponsor

Nanfang Hospital, Southern Medical University

Who can join

Adults 18 to 75, any sex, with Gastroesophageal Varices or Portal Hypertension. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Baveno VI criteria and spleen stiffness measurement rule out high-risk varices in virally suppressed HBV-related cirrhosis.
    Wang H, Wen B, Chang X, Wu Q, et al · · 2021 · cited 59× · PMID 33039403 · DOI 10.1016/j.jhep.2020.09.034
  2. Baveno VI-SSM stratifies the risk of portal hypertension-related events in patients with HBV-related cirrhosis.
    Wang H, Liang W, Zhou L, Song J, et al · · 2025 · cited 10× · PMID 39905841 · DOI 10.3350/cmh.2024.0609
  3. Indocyanine Green Clearance Test via Pulse Dye Densitometry for Portal Hypertension Diagnosis in cACLD.
    Liu M, Zhang X, Cheng X, He Q, et al · · 2025 · cited 1× · PMID 41178521 · DOI 10.1111/liv.70425

Verify or expand the search:

Other recruiting trials for Gastroesophageal Varices

Currently open trials in the same condition.

Other Nanfang Hospital, Southern Medical University trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04123509.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing