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

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ClinicalTrials.gov Identifier: NCT03778775
Recruitment Status : Recruiting
First Posted : December 18, 2018
Last Update Posted : December 18, 2018
Sponsor:
Collaborators:
Beijing Tsinghua Changgung Hospital of Tsinghua University
LanZhou University
The Fifth Medical Center of Chinese PLA General Hospital
Xijing Hospital of Digestive Diseases
Wuhan Union Hospital, China
Zhujiang Hospital
Second Affiliated Hospital of Xi'an Jiaotong University
The Central Hospital of Lishui City
Xingtai People's Hospital
The Seventh Medical Center of Chinese PLA General Hospital
Shandong Provincial Hospital
Shunde Hospital, Southern Medical University
Medistra Hospital, University of Indonesia
Ankara University
Osaka City University
Chulalongkorn University
Information provided by (Responsible Party):
Xiaolong Qi, Nanfang Hospital of Southern Medical University

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.


Condition or disease Intervention/treatment
Compensated Liver Cirrhosis Gastroesophageal Varices Bleeding Diagnostic Test: Liver sitffness measurement

Detailed Description:

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 (Beijing Tsinghua Changgung Hospital, Lanzhou University, The Fifth Medical Center of Chinese PLA General Hospital, Xijing Hospital of Digestive Diseases Wuhan Union Hospital, Zhujiang Hospital, Second Affiliated Hospital of Xi'an Jiaotong University, The Central Hospital of Lishui City, Xingtai People's Hospital, The Seventh Medical Center of Chinese PLA General Hospital Shandong Provincial Hospital, Shunde Hospital, Southern Medical University Medistra Hospital; University of Indonesia, Ankara University School of Medicine, Osaka City University, Chulalongkorn University) to develop and validate the diagnostic performance of FibroTouch-based models for assessing risk of gastroesophageal varices bleeding in compensated cirrhosis.


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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Transient Elastography (FibroTouch) for Assessing Risk of Gastroesophageal Varices Bleeding in Patients With Compensated Cirrhosis (Pan-CHESS1801): An International Multicenter Study
Actual Study Start Date : December 14, 2018
Estimated Primary Completion Date : October 13, 2019
Estimated Study Completion Date : October 13, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Overall eligible participants
Eligible participants will receive standard esophagogastroduodenoscopy and liver stiffness measurement by FibroTouch.
Diagnostic Test: Liver sitffness measurement
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.
Other Name: Esophagogastroduodenoscopy




Primary Outcome Measures :
  1. Diagnostic accuracy of FibroTouch-based models for the risk of variceal bleeding [ Time Frame: 1 day ]
    Diagnostic accuracy of FibroTouch-based models to determine the high-risk or low-risk of variceal bleeding with esophagogastroduodenoscopy as the reference standard


Secondary Outcome Measures :
  1. The correlation between FibroTouch-based models and HVPG [ Time Frame: 1 day ]
    The correlation between FibroTouch-based models and hepatic venous pressure gradient (HVPG)

  2. Diagnostic accuracy of FibroTouch-based models for the decompensated events of cirrhotic portal hypertension [ Time Frame: 1 year ]
    Diagnostic accuracy of FibroTouch-based models to determine the presence or absence of decompensated events (e.g. first variceal bleeding) within 1-year follow-up



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants with compensated liver cirrhosis
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03778775


Contacts
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Contact: Xiaolong Qi, MD 18588602600 qixiaolong@vip.163.com

Locations
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China, Beijing
The Seventh Medical Center of Chinese PLA General Hospital Recruiting
Beijing, Beijing, China, 100000
Contact: Shuai Wang, M.D.         
Principal Investigator: Shuai Wang, M.D.         
Sub-Investigator: Yasong Li, M.D.         
The Fifth Medical Center of Chinese PLA General Hospital Not yet recruiting
Beijing, Beijing, China, 100039
Contact: Guofeng Chen         
Principal Investigator: Guofeng Chen, M.D.         
Sub-Investigator: Dong Ji, M.D.         
Beijing Tsinghua Changgung Hospital of Tsinghua University Not yet recruiting
Beijing, Beijing, China, 102218
Contact: Jiahong Dong         
Principal Investigator: Jiahong Dong, M.D.         
Sub-Investigator: Lin Zhang, M.D.         
China, Gansu
The First Hospital of Lanzhou University Not yet recruiting
Lanzhou, Gansu, China
Contact: Xiaorong Mao, M.D.         
Principal Investigator: Xun Li, M.D.         
Sub-Investigator: Xiaorong Mao, M.D.         
China, Guangdong
Zhujiang Hospital, Southern Medical University Recruiting
Guangzhou, Guangdong, China, 510000
Contact: Hua Mao         
Principal Investigator: Hua Mao, M.D.         
Shunde Hospital, Southern Medical University Not yet recruiting
Shunde, Guangdong, China
Contact: Guoping Du, M.D.         
Principal Investigator: Guoping Du, M.D.         
China, Hebei
Xingtai People's Hospital Not yet recruiting
Xingtai, Hebei, China
Contact: Dengxiang Liu, M.D.         
Principal Investigator: Dengxiang Liu, M.D.         
Sub-Investigator: Qingge Zhang, M.D.         
China, Hubei
Wuhan Union Hospital, China Not yet recruiting
Wuhan, Hubei, China, 430022
Contact: Ling Yang, M.D.         
Principal Investigator: Xiaohua Hou, M.D.         
Sub-Investigator: Ling Yang, M.D.         
China, Shandong
Shandong Provincial Hospital Not yet recruiting
Jinan, Shandong, China
Contact: Chunqing Zhang, M.D.         
Principal Investigator: Chunqing Zhang, M.D.         
Sub-Investigator: Jing Wang, M.D.         
China, Shanxi
Xijing Hospital of Digestive Diseases Not yet recruiting
Xi'an, Shanxi, China
Contact: Ying Han, M.D.         
Principal Investigator: Ying Han, M.D.         
The Second Affiliated Hospital of Xi'an Jiaotong University Not yet recruiting
Xian, Shanxi, China
Contact: Zongfang Li, M.D.         
Principal Investigator: Zongfang Li, M.D.         
Sub-Investigator: Fanpu Ji, M.D.         
China, Zhejiang
The Central Hospital of Lishui City Not yet recruiting
Lishui, Zhejiang, China
Contact: Jiansong Ji, M.D.         
Principal Investigator: Jiansong Ji, M.D.         
Sub-Investigator: Zhongwei Zhao, M.D.         
Indonesia
Medistra Hospital, University of Indonesia Not yet recruiting
Jakarta, Indonesia
Contact: Cosmas Rinaldi A. Lesmana, M.D.         
Principal Investigator: Cosmas Rinaldi A. Lesmana, M.D.         
Japan
Osaka City University Not yet recruiting
Osaka, Japan
Contact: Norifumi Kawada, M.D.         
Principal Investigator: Norifumi Kawada, M.D.         
Thailand
Department of Medicine, Chulalongkorn University Not yet recruiting
Bangkok, Thailand
Contact: Sombat Treeprasertsuk, M.D.         
Principal Investigator: Sombat Treeprasertsuk, M.D.         
Turkey
Ankara University School of Medicine Not yet recruiting
Ankara, Turkey
Contact: Necati Örmeci, M.D.         
Principal Investigator: Necati Örmeci, M.D.         
Sponsors and Collaborators
Nanfang Hospital of Southern Medical University
Beijing Tsinghua Changgung Hospital of Tsinghua University
LanZhou University
The Fifth Medical Center of Chinese PLA General Hospital
Xijing Hospital of Digestive Diseases
Wuhan Union Hospital, China
Zhujiang Hospital
Second Affiliated Hospital of Xi'an Jiaotong University
The Central Hospital of Lishui City
Xingtai People's Hospital
The Seventh Medical Center of Chinese PLA General Hospital
Shandong Provincial Hospital
Shunde Hospital, Southern Medical University
Medistra Hospital, University of Indonesia
Ankara University
Osaka City University
Chulalongkorn University
Investigators
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Principal Investigator: Jiahong Dong, MD Beijing Tsinghua Changgung Hospital of Tsinghua University
Principal Investigator: Xiaolong Qi, MD Nanfang Hospital of Southern Medical University

Publications:

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Responsible Party: Xiaolong Qi, Director, Hepatic Hemodynamic Lab, Nanfang Hospital of Southern Medical University
ClinicalTrials.gov Identifier: NCT03778775     History of Changes
Other Study ID Numbers: Pan-CHESS1801
First Posted: December 18, 2018    Key Record Dates
Last Update Posted: December 18, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Undecided.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Xiaolong Qi, Nanfang Hospital of Southern Medical University:
Transient elastography
Gastroesophageal varices bleeding
Varices needing treatment

Additional relevant MeSH terms:
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Liver Cirrhosis
Esophageal and Gastric Varices
Varicose Veins
Hemorrhage
Fibrosis
Pathologic Processes
Liver Diseases
Digestive System Diseases
Vascular Diseases
Cardiovascular Diseases
Esophageal Diseases
Gastrointestinal Diseases
Hypertension, Portal