Development and Validation of an Noninvasive Model for Predicting High Risk Esophageal Varices in Cirrhosis

NCT04210297 | Completed DMC

• 1 other identifier: LinMaxwell2018
• Study Type: observational
• Target: 245
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to develop and validate a new noninvasive method based on routine examination during clinical practice for predicting high risk esophageal varices in cirrhosis.

Conditions

Esophageal and Gastric Varices

Keywords

noninvasive; portal hypertension; radiomics

Outcome Measures

Primary Outcomes (3)

• Accuracy

  The golden standard is endoscopic examination.Compare the accuracy of the noninvasive model with the endoscopic examination.

  through study completion, up to 2 years

• sensitivity

  the sensitivity of predicting high risk esophageal varices of the noninvasive model.

  through study completion, up to 2 years

• specificity

  the specificity of predicting high risk esophageal varices of the noninvasive model.

  through study completion, up to 2 years

Study Arms (3)

Training cohort

Training cohort consists of the cirrhotic patients who collected from January 2018 to December 2019 of Qilu Hospital retrospectively.

Internal validation cohort

Internal validation cohort consists of the cirrhotic patients who enrolled from January 2020 of Qilu Hospital prospectively.

External validation cohort

External validation cohort consists of the cirrhotic patients who enrolled from January 2020 in Jinan Central Hospital prospectively.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

We queried the cirrhotic patients treated in Qilu Hospital Affiliated to Shandong University and Jinan Central Hospital Affiliated to Shandong University.

You may qualify if:

• patients who were diagnosed with liver cirrhosis.
• patients who underwent the abdominal contrast-enhanced CT examination.
• patients who received endoscopic screening.
• patients with written informed consent.

You may not qualify if:

• patients who previously underwent endoscopic therapy, transjugular intrahepatic portosystemic shunt (TIPS), splenectomy, partial splenic embolization (PSE), hepatectomy, balloon-occluded retrograde transvenous obliteration, or liver transplantation.
• patients with liver cancer.
• patients with severe ascites or hepatic encephalopathy.
• lacks abdominal contrast-enhanced CT within 1 month of endoscopy.

Sponsors & Collaborators

• Qilu Hospital of Shandong University: lead
• Jinan Central Hospital: collaborator

Study Sites (1)

Department of Gastroenterology,Qilu Hospital,Shandong University

Jinan, Shandong, 250012, China

Location

Related Publications (1)

• Lin Y, Li L, Yu D, Liu Z, Zhang S, Wang Q, Li Y, Cheng B, Qiao J, Gao Y. A novel radiomics-platelet nomogram for the prediction of gastroesophageal varices needing treatment in cirrhotic patients. Hepatol Int. 2021 Aug;15(4):995-1005. doi: 10.1007/s12072-021-10208-4. Epub 2021 Jun 11.

  PMID: 34115257 DERIVED

MeSH Terms

Conditions

Esophageal and Gastric Varices; Hypertension, Portal

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Liver Diseases

Study Officials

• Yanjing Gao, PhD.MD

  Qilu Hospital of Shandong University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: December 15, 2019
• First Posted: December 24, 2019
• Study Start: January 1, 2018
• Primary Completion: October 1, 2019
• Study Completion: January 1, 2021
• Last Updated: May 14, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)