Radiomics-based Surrogate of Endoscopy (rEndosc) (CHESS1703)

NCT03373123 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2019-06-19

No results posted yet for this study

Summary

Esophageal varices (EVs) resulting from portal hypertension are a prevalent complication of cirrhosis with a high mortality when variceal hemorrhage (VH) occurs. Screening endoscopy for EVs is recommended for all patients with cirrhosis, and prophylactic treatments are proposed for preventing VH, which may be financially onerous. Therefore, noninvasive tools for diagnosing EVs and risk stratifying VH in cirrhotic patients are needed to decrease the number of unnecessary invasive endoscopic examinations of low-risk patients and avoid unneeded prophylactic treatment. This is a prospective, multi-center diagnostic trial conducted at 9 high-volume liver centers in China designed to determine the diagnostic performance of radiomics-based surrogate (rEndosc) (investigational technology) by CT imaging for noninvasive prediction of EVs and risk stratification of VH in patients with hepatitis B virus-related cirrhosis using endoscopic examinations as reference standard.

Conditions

  • Esophageal Varices in Cirrhosis of the Liver

Interventions

PROCEDURE

Endoscopy

Endoscopy

PROCEDURE

CTA

Radiomic features were extracted from CTA images.

Sponsors & Collaborators

  • Beijing YouAn Hospital

    collaborator OTHER
  • Beijing 302 Hospital

    collaborator OTHER
  • Shandong Provincial Hospital

    collaborator OTHER_GOV
  • Beijing Friendship Hospital

    collaborator OTHER
  • The Second Affiliated Hospital of Chongqing Medical University

    collaborator OTHER
  • Chinese PLA General Hospital

    collaborator OTHER
  • Peking University People's Hospital

    collaborator OTHER
  • Xingtai People's Hospital

    collaborator OTHER
  • Nanfang Hospital, Southern Medical University

    lead OTHER

Principal Investigators

  • Huiguo Ding, M.D. · Beijing YouAn Hospital

  • Xiaolong Qi, M.D. · Nanfang Hospital, Southern Medical University

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-12-18
Primary Completion
2018-12-18
Completion
2018-12-18

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03373123 on ClinicalTrials.gov