Transient Elastography (FibroTouch) for Assessing Risk of Gastroesophageal Varices Bleeding in Compensated Cirrhosis (Pan-CHESS1801)

NCT03778775 | Unknown DMC

• 1 other identifier: Pan-CHESS1801
• Study Type: observational
• Target: 200
• Locations: 5 countries
• Sites: 16

Brief Summary

Gastroesophageal varices occurs in approximately half of the patients with liver cirrhosis. Variceal bleeding is the most common lethal complication directly from cirrhotic portal hypertension. The golden standard for diagnosing gastroesophageal varices and evaluating the risk of variceal bleeding is the esophagogastroduodenoscopy. According to the Baveno VI consensus, for those with high-risk varices (varies needing treatment), either non-selective beta blockers or endoscopic band ligation is recommended for the prevention of the first variceal bleeding. However, the invasiveness and uncomfortableness during the esophagogastroduodenoscopy procedure has hindered its routine use in clinical practice, especially in compensated cirrhotic patients. The important role of transient elastography for defining the presence of high-risk varices was highlighted in the Baveno VI consensus workshop that cirrhotic patients with a liver stiffness measurement (LSM) of less than 20 kPa and a platelet count of greater than 150,000/μL can avoid screening endoscopy. In addition, transient elastography-based models (e.g. LSM combined with platelet count, liver stiffness spleen diameter-to-platelet score) were shown to have potentials in distinguish the absence of high-risk gastroesophageal varices. However, this cutoff value of LSM was validated mainly in cohorts with alcoholic or hepatitis C virus dominated cirrhosis. The unmet need is a precise cutoff to rule out high-risk varices in hepatitis B virus dominated cirrhosis, which is an outstanding issue in Asia-Pacific population. FibroTouch (Hisky Medical Technologies Co. Ltd, Wuxi, China) is a new-generation of transient elastography based on a two-dimensional image-guided system to ensure the precise orientation. In the present study, the investigators aim to conduct an international prospective diagnostic trial with 16 sites to develop and validate the diagnostic performance of FibroTouch-based models for assessing risk of gastroesophageal varices bleeding in compensated cirrhosis.

Conditions

Compensated Liver Cirrhosis; Gastroesophageal Varices Bleeding

Keywords

Transient elastography; Gastroesophageal varices bleeding; Varices needing treatment

Outcome Measures

Primary Outcomes (1)

• Diagnostic accuracy of FibroTouch-based models for the risk of variceal bleeding

  Diagnostic accuracy of FibroTouch-based models to determine the high-risk or low-risk of variceal bleeding with esophagogastroduodenoscopy as the reference standard

  1 day

Secondary Outcomes (2)

• The correlation between FibroTouch-based models and HVPG

  1 day

• Diagnostic accuracy of FibroTouch-based models for the decompensated events of cirrhotic portal hypertension

  1 year

Study Arms (1)

Overall eligible participants

Eligible participants will receive standard esophagogastroduodenoscopy and liver stiffness measurement by FibroTouch.

Diagnostic Test: Liver sitffness measurement

Interventions

Liver sitffness measurement DIAGNOSTIC_TEST

Liver sitffness measurement is performed by FibroTouch, a new-generation of transient elastography with the tesing interval between liver sitffness measurement and esophagogastroduodenoscopy less than one week.

Also known as: Esophagogastroduodenoscopy

Overall eligible participants

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants with compensated liver cirrhosis

You may qualify if:

• age 18-75 years;
• confirmed liver cirrhosis based on liver biopsy or clinical findings;
• compensated liver cirrhosis;
• scheduled to undergo esophagogastroduodenoscopy;
• estimated survival time\> 24 months, and model for end-stage liver disease (MELD) score\< 19;
• with written informed consent.

You may not qualify if:

• contradictions for esophagogastroduodenoscopy;
• body mass index\> 35 kg/m2;
• presence of decompensation events (e.g. ascites, variceal bleeding, hepatic encephalopathy, etc.);
• previous esophageal variceal banding legation or transjugular intrahepatic portosystemic shunt;
• current use of non-selective beta-blockers;
• with portal vein thrombosis or hepatocellular carcinoma;
• non-cirrhotic portal hypertension;
• pregnancy or unknown pregnancy status.

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead
• Beijing Tsinghua Changgeng Hospital: collaborator
• LanZhou University: collaborator
• Beijing 302 Hospital: collaborator
• Xijing Hospital of Digestive Diseases: collaborator
• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: collaborator
• Zhujiang Hospital: collaborator
• Second Affiliated Hospital of Xi'an Jiaotong University: collaborator
• The Central Hospital of Lishui City: collaborator
• Xingtai People's Hospital: collaborator
• Seventh Medical Center of PLA Army General Hospital: collaborator
• Shandong Provincial Hospital: collaborator
• Southern Medical University, China: collaborator
• Medistra Hospital, University of Indonesia: collaborator
• Ankara University: collaborator
• Osaka City University: collaborator
• Chulalongkorn University: collaborator

Study Sites (16)

The Seventh Medical Center of Chinese PLA General Hospital

Beijing, Beijing Municipality, 100000, China

RECRUITING

The Fifth Medical Center of Chinese PLA General Hospital

Beijing, Beijing Municipality, 100039, China

NOT YET RECRUITING

Beijing Tsinghua Changgung Hospital of Tsinghua University

Beijing, Beijing Municipality, 102218, China

NOT YET RECRUITING

The First Hospital of Lanzhou University

Lanzhou, Gansu, China

NOT YET RECRUITING

Zhujiang Hospital, Southern Medical University

Guangzhou, Guangdong, 510000, China

RECRUITING

Shunde Hospital, Southern Medical University

Shunde, Guangdong, China

NOT YET RECRUITING

Xingtai People's Hospital

Xingtai, Hebei, China

NOT YET RECRUITING

Wuhan Union Hospital, China

Wuhan, Hubei, 430022, China

NOT YET RECRUITING

Shandong Provincial Hospital

Jinan, Shandong, China

NOT YET RECRUITING

The Second Affiliated Hospital of Xi'an Jiaotong University

Xian, Shanxi, China

NOT YET RECRUITING

Xijing Hospital of Digestive Diseases

Xi’an, Shanxi, China

NOT YET RECRUITING

The Central Hospital of Lishui City

Lishui, Zhejiang, China

NOT YET RECRUITING

Medistra Hospital, University of Indonesia

Jakarta, Indonesia

NOT YET RECRUITING

Osaka City University

Osaka, Japan

NOT YET RECRUITING

Department of Medicine, Chulalongkorn University

Bangkok, Thailand

NOT YET RECRUITING

Ankara University School of Medicine

Ankara, Turkey (Türkiye)

NOT YET RECRUITING

Related Publications (8)

• Qi X, Berzigotti A, Cardenas A, Sarin SK. Emerging non-invasive approaches for diagnosis and monitoring of portal hypertension. Lancet Gastroenterol Hepatol. 2018 Oct;3(10):708-719. doi: 10.1016/S2468-1253(18)30232-2.

  PMID: 30215362 BACKGROUND

• Liu F, Ning Z, Liu Y, Liu D, Tian J, Luo H, An W, Huang Y, Zou J, Liu C, Liu C, Wang L, Liu Z, Qi R, Zuo C, Zhang Q, Wang J, Zhao D, Duan Y, Peng B, Qi X, Zhang Y, Yang Y, Hou J, Dong J, Li Z, Ding H, Zhang Y, Qi X. Development and validation of a radiomics signature for clinically significant portal hypertension in cirrhosis (CHESS1701): a prospective multicenter study. EBioMedicine. 2018 Oct;36:151-158. doi: 10.1016/j.ebiom.2018.09.023. Epub 2018 Sep 27.

  PMID: 30268833 BACKGROUND

• Wang FS, Fan JG, Zhang Z, Gao B, Wang HY. The global burden of liver disease: the major impact of China. Hepatology. 2014 Dec;60(6):2099-108. doi: 10.1002/hep.27406. Epub 2014 Oct 29.

  PMID: 25164003 BACKGROUND

• 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.

  PMID: 26047908 BACKGROUND

• Berzigotti A, Seijo S, Arena U, Abraldes JG, Vizzutti F, Garcia-Pagan JC, Pinzani M, Bosch J. Elastography, spleen size, and platelet count identify portal hypertension in patients with compensated cirrhosis. Gastroenterology. 2013 Jan;144(1):102-111.e1. doi: 10.1053/j.gastro.2012.10.001. Epub 2012 Oct 8.

  PMID: 23058320 BACKGROUND

• Bhardwaj A, Kedarisetty CK, Vashishtha C, Bhadoria AS, Jindal A, Kumar G, Choudhary A, Shasthry SM, Maiwall R, Kumar M, Bhatia V, Sarin SK. Carvedilol delays the progression of small oesophageal varices in patients with cirrhosis: a randomised placebo-controlled trial. Gut. 2017 Oct;66(10):1838-1843. doi: 10.1136/gutjnl-2016-311735. Epub 2016 Jun 13.

  PMID: 27298379 BACKGROUND

• Zhu Q, Wang W, Zhao J, Al-Asbahi AAM, Huang Y, Du F, Zhou J, Song Y, Xu K, Ye J, Yang L. Transient Elastography Identifies the Risk of Esophageal Varices and Bleeding in Patients With Hepatitis B Virus-Related Liver Cirrhosis. Ultrasound Q. 2018 Sep;34(3):141-147. doi: 10.1097/RUQ.0000000000000373.

  PMID: 30020268 BACKGROUND

• Qi X, An W, Liu F, Qi R, Wang L, Liu Y, Liu C, Xiang Y, Hui J, Liu Z, Qi X, Liu C, Peng B, Ding H, Yang Y, He X, Hou J, Tian J, Li Z. Virtual Hepatic Venous Pressure Gradient with CT Angiography (CHESS 1601): A Prospective Multicenter Study for the Noninvasive Diagnosis of Portal Hypertension. Radiology. 2019 Feb;290(2):370-377. doi: 10.1148/radiol.2018180425. Epub 2018 Nov 20.

  PMID: 30457484 BACKGROUND

MeSH Terms

Interventions

Endoscopy, Digestive System

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Jiahong Dong, MD

  Beijing Tsinghua Changgeng Hospital

  PRINCIPAL INVESTIGATOR

• Xiaolong Qi, MD

  Nanfang Hospital, Southern Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaolong Qi, MD

CONTACT

18588602600; qixiaolong@vip.163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Hepatic Hemodynamic Lab

Study Record Dates

• First Submitted: December 16, 2018
• First Posted: December 19, 2018
• Study Start: December 14, 2018
• Primary Completion: June 13, 2021
• Study Completion: March 13, 2022
• Last Updated: August 17, 2021

Record last verified: 2021-08

Locations

CN (12); TH (1); ID (1); JP (1); TU (1)