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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-18

Study Completion Date

2018-12-18

Brief Summary

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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.

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Detailed Description

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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 (Beijing YouAn Hospital, Capital Medical University; Nanfang Hospital, Southern Medical University; 302 Hospital of PLA; Shandong Provincial Hospital; Beijing Friendship Hospital, Capital Medical University; Chinese PLA General Hospital; Peking University People's Hospital; Xingtai People's Hospital) 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

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Esophageal Varices in Cirrhosis of the Liver

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Single arm study

Patients will receive CTA, Endoscopy, and rEndosc per protocol. Intervention: Procedure: Endoscopy

Group Type EXPERIMENTAL

Endoscopy

Intervention Type PROCEDURE

Endoscopy

CTA

Intervention Type PROCEDURE

Radiomic features were extracted from CTA images.

Interventions

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Endoscopy

Intervention Type PROCEDURE

CTA

Radiomic features were extracted from CTA images.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 18-75 years;
* HBsAg positive;
* confirmed cirrhosis based on results of histologic examination of liver tissue or combined physical, laboratory, and radiologic findings, including a nodular surface, a coarse texture, and an enlarged caudate lobe of the liver on ultrasonography, CT, or MR imaging.

Exclusion Criteria

* active alcohol abuse (less than 6 months of alcohol abstinence); portal thrombosis;
* history of treatments for portal hypertension (drug therapy, such as β-blocker, vasopressin) within 2 weeks;
* prior surgeries (such as splenectomy, partial splenic embolization/devascularization, transjugular intrahepatic portosystemic shunt);
* prior endoscopic therapies (such as endoscopic variceal ligation);
* previous variceal hemorrhage;
* acute-on-chronic (sub-acute) liver failure;
* malignant tumor (such as hepatocellular carcinoma);
* cirrhotic portal hypertension with isolated gastric varices or ectopic varices;
* inability to adhere to study procedures (such as heart failure, renal failure);
* pregnancy or unknown pregnancy status;
* no informed consent.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Xiaolong Qi

Director, Portal Hypertension Research, Institute of Hepatology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Huiguo Ding, M.D.

Role: PRINCIPAL_INVESTIGATOR

Beijing YouAn Hospital

Xiaolong Qi, M.D.

Role: PRINCIPAL_INVESTIGATOR

Nanfang Hospital, Southern Medical University

Locations

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