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Trial record 3 of 3 for:    23058320 [PUBMED-IDS]

Magnetically Controlled Capsule Endoscopy for Assessing Risk of Gastroesophageal Varices Bleeding in Compensated Cirrhosis (CHESS1801)

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ClinicalTrials.gov Identifier: NCT03749954
Recruitment Status : Recruiting
First Posted : November 21, 2018
Last Update Posted : June 18, 2019
Sponsor:
Collaborators:
PLA Army General Hospital
Sir Run Run Shaw Hospital, Medical College, Zhejiang University
Zhujiang Hospital
Shandong Provincial Hospital
Shanghai Tongji Hospital, Tongji University School of Medicine
The First Affiliated Hospital of Nanchang University
Zhongda Hospital, Medical School, Southeast University
Guangdong Second Provincial General Hospital
the Fifth Affiliated Hospital of Zunyi Medical University
LanZhou University
Xingtai People's Hospital
Information provided by (Responsible Party):
Xiaolong Qi, LanZhou University

Brief Summary:

Gastroesophageal varices occurs in approximately half of the patients with cirrhosis. Variceal bleeding is the most common lethal complication directly from cirrhotic portal hypertension. The gold 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 use in clinical practice, especially in patients with compensated cirrhosis.

Magnetically controlled capsule endoscopy, as an emerging non-invasive technique, has been well established and shown the comparable accuracy for detection of focal lesions in the stomach compared with conventional esophagogastroduodenoscopy. In the present study, the investigators aim to conduct a prospective, multicenter diagnostic trial with 12 sites in China to further evaluate the diagnostic performance of magnetically controlled capsule endoscopy (Ankon Medical Technologies Co. Ltd.) for assessing risk of gastroesophageal varices bleeding in compensated cirrhosis.


Condition or disease Intervention/treatment
Compensated Cirrhosis Gastroesophageal Varices Bleeding Diagnostic Test: Magnetically controlled capsule endoscopy

Detailed Description:

Gastroesophageal varices occurs in approximately half of the patients with cirrhosis. Variceal bleeding is the most common lethal complication directly from cirrhotic portal hypertension. The gold 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 use in clinical practice, especially in patients with compensated cirrhosis.

Magnetically controlled capsule endoscopy, as an emerging non-invasive technique, has been well established and shown the comparable accuracy for detection of focal lesions in the stomach compared with conventional esophagogastroduodenoscopy. In the present study, the investigators aim to conduct a prospective, multicenter diagnostic trial with 12 sites (PLA Army General Hospital; Sir Run Run Shaw Hospital, Medical College, Zhejiang University; Zhujiang Hospital, Southern Medical University; Shandong Provincial Hospital affiliated to Shandong University; Shanghai Tongji Hospital, Tongji University School of Medicine; The First Affiliated Hospital of Nanchang University; Nanfang Hospital, Southern Medical University; Zhongda Hospital, Medical School, Southeast University; Guangdong Second Provincial General Hospital; The Fifth Affiliated Hospital of Zunyi Medical University; The First Hospital of Lanzhou University; Xingtai People's Hospital) in China to further evaluate the diagnostic performance of magnetically controlled capsule endoscopy (Ankon Medical Technologies Co. Ltd.) for assessing risk of gastroesophageal varices bleeding in compensated cirrhosis.


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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Magnetically Controlled Capsule Endoscopy for Assessing Risk of Gastroesophageal Varices Bleeding in Compensated Liver Cirrhosis (CHESS1801): A Prospective Multicenter Study
Actual Study Start Date : November 9, 2018
Estimated Primary Completion Date : November 8, 2019
Estimated Study Completion Date : November 8, 2022

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Overall eligible participants
Eligible participants will receive standard esophagogastroduodenoscopy and magnetically controlled capsule endoscopy (Ankon Medical Technologies Co. Ltd.).
Diagnostic Test: Magnetically controlled capsule endoscopy
Esophagogastroduodenoscopy is performed 2 hours after the magnetically controlled capsule endoscopy (Ankon Medical Technologies Co. Ltd.).
Other Name: Esophagogastroduodenoscopy




Primary Outcome Measures :
  1. Diagnostic accuracy of magnetically controlled capsule endoscopy for the risk of variceal bleeding [ Time Frame: 1 day ]
    Diagnostic accuracy of magnetically controlled capsule endoscopy to determine the high-risk or low-risk of variceal bleeding when compared with esophagogastroduodenoscopy as the reference standard


Secondary Outcome Measures :
  1. Diagnostic accuracy of magnetically controlled capsule endoscopy for decompensation or death [ Time Frame: 3 year ]
    Diagnostic accuracy of magnetically controlled capsule endoscopy to determine the presence or absence of decompensation (defined as development of ascites, bleeding, or overt encephalopathy) or death within 3-year follow-up

  2. Diagnostic accuracy of other non-invasive methods for the risk of variceal bleeding [ Time Frame: 1 day ]
    Diagnostic accuracy of other non-invasive methods to determine the high-risk or low-risk of variceal bleeding when compared with esophagogastroduodenoscopy as the reference standard

  3. Diagnostic accuracy of other non-invasive methods for decompensation or death [ Time Frame: 3 year ]
    Diagnostic accuracy of other non-invasive methods to determine the presence or absence of decompensation (defined as development of ascites, bleeding, or overt encephalopathy) or death within 3-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 cirrhosis
Criteria

Inclusion Criteria:

  • age 18-75 years;
  • confirmed cirrhosis based on liver biopsy or clinical findings;
  • compensated 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 capsule endoscopy;
  • contradictions for standard magnetic resonance imaging examination such as the presence of surgical metallic devices;
  • 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): NCT03749954


Contacts
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Contact: Xiaolong Qi, M.D. +8618588602600 ext +8618588602600 qixiaolong@vip.163.com
Contact: Yanna Liu +8615625076784 ext +8618588602600 lauyenna@126.com

Locations
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China, Beijing
PLA Army General Hospital Recruiting
Beijing, Beijing, China
Contact: Shuai Wang, M.D.         
Principal Investigator: Shuai Wang, M.D.         
China, Gansu
The First Hospital of Lanzhou University Not yet recruiting
Lanzhou, Gansu, China
Contact: Xun Li, M.D.         
Principal Investigator: Xun Li, M.D.         
China, Guangdong
Guangdong Second Provincial General Hospital Recruiting
Guangzhou, Guangdong, China
Contact: Ming Xu, M.D.         
Principal Investigator: Ming Xu, M.D.         
Nanfang Hospital, Southern Medical University Recruiting
Guangzhou, Guangdong, China
Contact: Jinlin Hou, M.D.         
Principal Investigator: Jinlin Hou, M.D.         
Zhujiang Hospital, Southern Medical University Recruiting
Guangzhou, Guangdong, China
Contact: Hua Mao, M.D.         
Principal Investigator: Hua Mao, M.D.         
The Fifth Affiliated Hospital of Zunyi Medical University Recruiting
Zhuhai, Guangdong, China
Contact: Zhaohui He, M.D.         
Principal Investigator: Zhaohui He, 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.         
China, Jiangsu
Zhongda Hospital, Medical School, Southeast University Recruiting
Nanjing, Jiangsu, China
Contact: Ruihua Shi, M.D.         
Principal Investigator: Ruihua Shi, M.D.         
China, Jiangxi
The First Affiliated Hospital of Nanchang University Recruiting
Nanchang, Jiangxi, China
Contact: Xuan Zhu, M.D.         
Principal Investigator: Xuan Zhu, M.D.         
China, Shandong
Shandong Provincial Hospital affiliated to Shandong University Recruiting
Jinan, Shandong, China
Contact: Chunqing Zhang, M.D.         
Principal Investigator: Chunqing Zhang, M.D.         
China, Shanghai
Shanghai Tongji Hospital, Tongji University School of Medicine Recruiting
Shanghai, Shanghai, China
Contact: Li Yang, M.D.         
Principal Investigator: Li Yang, M.D.         
China, Zhejiang
Sir Run Run Shaw Hospital Recruiting
Hangzhou, Zhejiang, China
Contact: Weilin Hu, M.D.         
Principal Investigator: Weilin Hu, M.D.         
Sponsors and Collaborators
Nanfang Hospital of Southern Medical University
PLA Army General Hospital
Sir Run Run Shaw Hospital, Medical College, Zhejiang University
Zhujiang Hospital
Shandong Provincial Hospital
Shanghai Tongji Hospital, Tongji University School of Medicine
The First Affiliated Hospital of Nanchang University
Zhongda Hospital, Medical School, Southeast University
Guangdong Second Provincial General Hospital
the Fifth Affiliated Hospital of Zunyi Medical University
LanZhou University
Xingtai People's Hospital
Investigators
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Principal Investigator: Xiaolong Qi, M.D. LanZhou University

Publications:

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Responsible Party: Xiaolong Qi, Professor, LanZhou University
ClinicalTrials.gov Identifier: NCT03749954     History of Changes
Other Study ID Numbers: CHESS1801
First Posted: November 21, 2018    Key Record Dates
Last Update Posted: June 18, 2019
Last Verified: June 2019
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, LanZhou University:
Magnetically controlled capsule endoscopy
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