Transient Elastography (FibroTouch) for Assessing Risk of Gastroesophageal Varices Bleeding in Compensated Cirrhosis (Pan-CHESS1801)
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| ClinicalTrials.gov Identifier: NCT03778775 |
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Recruitment Status :
Recruiting
First Posted : December 19, 2018
Last Update Posted : August 17, 2021
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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 |
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.
| 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 |
| Actual Primary Completion Date : | June 13, 2021 |
| Estimated Study Completion Date : | March 13, 2022 |
| Group/Cohort | Intervention/treatment |
|---|---|
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Overall eligible participants
Eligible participants will receive standard esophagogastroduodenoscopy and liver stiffness measurement by FibroTouch.
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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 |
- 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
- The correlation between FibroTouch-based models and HVPG [ Time Frame: 1 day ]The correlation between FibroTouch-based models and hepatic venous pressure gradient (HVPG)
- 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
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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 |
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.
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
| Contact: Xiaolong Qi, MD | 18588602600 | qixiaolong@vip.163.com |
| 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. | |
| Principal Investigator: | Jiahong Dong, MD | Beijing Tsinghua Changgeng Hospital | |
| Principal Investigator: | Xiaolong Qi, MD | Nanfang Hospital of Southern Medical University |
| Responsible Party: | Xiaolong Qi, Director, Hepatic Hemodynamic Lab, Nanfang Hospital of Southern Medical University |
| ClinicalTrials.gov Identifier: | NCT03778775 |
| Other Study ID Numbers: |
Pan-CHESS1801 |
| First Posted: | December 19, 2018 Key Record Dates |
| Last Update Posted: | August 17, 2021 |
| Last Verified: | August 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| Plan Description: | Undecided. |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Transient elastography Gastroesophageal varices bleeding Varices needing treatment |
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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 |