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Esophageal Varices in Cirrhosis of the LiverrEndoscNCT03373123

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

A study testing Endoscopy and CTA in people with Esophageal Varices in Cirrhosis of the Liver, run by Nanfang Hospital, Southern Medical University at 9 sites in China.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 75 yearsHealthy volunteers can take part
What is being tested?
Endoscopy and CTA
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
9 sitesChina
Study dates
18 Dec 2017to 18 Dec 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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;
Show all 11Show fewer
  • 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.

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

China9 sites

  • 302 Hospital of PLA

    Beijing, Beijing Municipality

  • Beijing Friendship Hospital, Capital Medical University

    Beijing, Beijing Municipality

  • Beijing YouAn Hospital, Capital Medical University

    Beijing, Beijing Municipality

  • Chinese PLA General Hospital

    Beijing, Beijing Municipality

  • Peking University People's Hospital

    Beijing, Beijing Municipality

  • The Second Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality

  • Nanfang Hospital, Southern Medical University

    Guangzhou, Guangdong

  • Shandong Provincial Hospital

    Jinan, Shandong

  • Xingtai People's Hospital

    Xingtai, Hebei

Other trials in China

About this study

Official title: Radiomics-based Surrogate of Endoscopy (rEndosc) for Noninvasive Prediction of Esophageal Varices and Risk Stratification of Variceal Hemorrhage in Hepatitis B Virus-related Cirrhosis (CHESS1703)

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.

Read the detailed description

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.

Being tested
Endoscopy, CTA
Keywords
Esophageal Varices, Variceal Hemorrhage, Endoscopy, Radiomics, Hepatitis B Virus
Medical subject headings
Esophageal and Gastric Varices, Hepatitis B

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EndoscopyProcedure or surgery

    Endoscopy

  • CTAProcedure or surgery

    Radiomic features were extracted from CTA images.

Study groups in NCT03373123
Study groupRoleWhat they receive
Single arm studyExperimentalPatients will receive CTA, Endoscopy, and rEndosc per protocol. Intervention: Procedure: Endoscopy
Receives: Procedure: Endoscopy; Procedure: CTA

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Diagnostic Accuracy of rEndosc for Esophageal Varices

    Diagnostic accuracy of rEndosc to determine the presence or absence of esophageal varices when compared to endoscopic examination as the reference standard

    Measured: 1 day

Secondary outcomes (2)

  1. Diagnostic Accuracy of rEndosc for the Risk of Variceal Hemorrhage

    Diagnostic accuracy of rEndosc to stratify risk of variceal hemorrhage when compared to endoscopic examination as the reference standard

    Measured: 1 day

  2. Diagnostic Accuracy of rEndosc for Variceal Hemorrhage

    Diagnostic accuracy of rEndosc to determine the presence or absence of variceal hemorrhage within 1-year follow-up

    Measured: 1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Dec 2017
  2. Study start18 Dec 2017
  3. Primary completion18 Dec 2018 (estimated)
  4. Study completion18 Dec 2018 (estimated)

Why it stopped: Funding issue

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03373123
Sponsor's protocol ID
CHESS1703
Acronym
rEndosc
Status last verified
Jun 2019
First submitted
5 Dec 2017
Last updated
19 Jun 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Garcia-Tsao G, Abraldes JG, Berzigotti A, Bosch J. Portal hypertensive bleeding in cirrhosis: Risk stratification, diagnosis, and management: 2016 practice guidance by the American Association for the study of liver diseases. Hepatology. 2017 Jan;65(1):310-335. doi: 10.1002/hep.28906. Epub 2016 Dec 1. No abstract available.

    PubMed 27786365

  • de Franchis R; Baveno VI Faculty. Expanding consensus in portal hypertension: Report of the Baveno VI Consensus Workshop: Stratifying risk and individualizing care for portal hypertension. J Hepatol. 2015 Sep;63(3):743-52. doi: 10.1016/j.jhep.2015.05.022. Epub 2015 Jun 3. No abstract available.

    PubMed 26047908

  • Gillies RJ, Kinahan PE, Hricak H. Radiomics: Images Are More than Pictures, They Are Data. Radiology. 2016 Feb;278(2):563-77. doi: 10.1148/radiol.2015151169. Epub 2015 Nov 18.

    PubMed 26579733

  • Segal E, Sirlin CB, Ooi C, Adler AS, Gollub J, Chen X, Chan BK, Matcuk GR, Barry CT, Chang HY, Kuo MD. Decoding global gene expression programs in liver cancer by noninvasive imaging. Nat Biotechnol. 2007 Jun;25(6):675-80. doi: 10.1038/nbt1306. Epub 2007 May 21.

    PubMed 17515910

  • Lambin P, Leijenaar RTH, Deist TM, Peerlings J, de Jong EEC, van Timmeren J, Sanduleanu S, Larue RTHM, Even AJG, Jochems A, van Wijk Y, Woodruff H, van Soest J, Lustberg T, Roelofs E, van Elmpt W, Dekker A, Mottaghy FM, Wildberger JE, Walsh S. Radiomics: the bridge between medical imaging and personalized medicine. Nat Rev Clin Oncol. 2017 Dec;14(12):749-762. doi: 10.1038/nrclinonc.2017.141. Epub 2017 Oct 4.

    PubMed 28975929

  • Huang YQ, Liang CH, He L, Tian J, Liang CS, Chen X, Ma ZL, Liu ZY. Development and Validation of a Radiomics Nomogram for Preoperative Prediction of Lymph Node Metastasis in Colorectal Cancer. J Clin Oncol. 2016 Jun 20;34(18):2157-64. doi: 10.1200/JCO.2015.65.9128. Epub 2016 May 2.

    PubMed 27138577

Questions about this trial

What is this clinical trial studying?

A study testing Endoscopy and CTA in people with Esophageal Varices in Cirrhosis of the Liver, run by Nanfang Hospital, Southern Medical University at 9 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 19 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Diagnostic Accuracy of rEndosc for Esophageal Varices (time frame: 1 day). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03373123, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2019.

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