Detachable String Magnetically Controlled Capsule Endoscopy for Detecting High-risk Varices in Compensated Cirrhosis

November 13, 2020 updated by: Xiaolong Qi, Nanfang Hospital of Southern Medical University

Detachable String Magnetically Controlled Capsule Endoscopy for Detecting High-risk Varices in Compensated Advanced Chronic Liver Disease (CHESS1801): A Prospective Multicenter Study

Gastroesophageal varices is a serious complication of compensated advanced chronic liver disease (cACLD). Primary prophylaxis to reduce the risk of variceal haemorrhage is recommended if high-risk varices (HRV) are detected. We performed this study to compare the accuracy, patients' satisfaction and safety of detection of HRV by detachable string magnetically controlled capsule endoscopy (DS-MCCE) with esophagogastroduodenoscopy (EGD) as the standard.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The presence of gastroesophageal varices (GEV) is a common and serious complication of compensated advanced chronic liver disease (cACLD).1-3 GEV hemorrhage is associated with a six week mortality rate of between 15% and 25%.2,3 In order to prevent variceal hemorrhage, screening and surveillance aims to detect high-risk varices (HRV) and determine the need for primary preventative therapy.2,3 Esophagogastroduodenoscopy (EGD) is therefore an important part of the diagnostic work-up in patients with cACLD, serving as the gold standard to diagnose HRV.2,3 However, EGD is invasive and poorly tolerated, with many patients needing intravenous sedatives or general anesthesia. Although EGD with sedation relieves patients' anxiety and discomfort and reduces the potential for physical injury during the procedure, it incurs additional risks of cardiopulmonary adverse events.4 Consequently, patients may decline a screening procedure if they are stable and asymptomatic.

Non-invasive methods for detection of cACLD are being explored.5-13 Although preliminary research is encouraging, these techniques predict the presence, rather than confirm or assess the size, of GEV. By contrast, capsule endoscopy is a non-invasive alternative which also allows direct visualization of GEV.14 A number of well-conducted trials15-19 suggest that EGD and capsule endoscopy may be equivalent in terms of accuracy in the identification and grading of varices. However, concerns remain that the quality of examination may be adversely affected by the uncontrolled and sometimes rapid transit of the capsule through the esophagus.20 String capsule endoscopy was introduced to address this concern by providing control of capsule movement as well as real-time visualization.21 However, this technique is limited by the inability to detach the string from the capsule. Thus, observation of the fundus, one of the predilection sites of varices, is impossible and retrieval of the capsule from the esophagus causes discomfort.

Magnetically controlled capsule endoscopy (MCCE), a novel modality, was developed and approved by the China Food and Drug Administration in 2013.22 Our previous studies initially demonstrated that MCCE was comparable in accuracy to EGD for gastric examination.22,23 Furthermore, it has several strengths including non-invasiveness, no sedation requirement, and easy operation.22,23 We have since combined an innovative detachable string system with the MCCE (detachable string magnetically controlled capsule endoscopy (DS-MCCE)) and carried out a pilot study showing that DS-MCCE was safe and feasible both in healthy volunteers and patients with suspected esophageal disease.24 Moreover, successful detachment of the capsule from the string avoids the discomfort of retrieving the entire capsule from the mouth and allows subsequent investigation of the gastric cardia and fundus. To our knowledge, the diagnostic accuracy of HRV, comfort and safety of DS-MCCE in patients with cACLD have not been explored in a large-scale trial. This prospective, multicenter study aimed to assess the accuracy, patient's satisfaction, and safety of DS-MCCE for detecting HRV in well-characterized patients with cACLD.

Study Type

Observational

Enrollment (Actual)

105

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Baotou, China
        • The Second Affiliated Hospital of Baotou Medical College
      • Guangzhou, China
        • Third Affiliated Hospital of Sun Yat-sen University
    • Beijing
      • Beijing, Beijing, China
        • The Fifth Medical Center of PLA General Hospital
    • Gansu
      • Lanzhou, Gansu, China
        • The First Hospital of Lanzhou University
    • Guangdong
      • Guangzhou, Guangdong, China
        • Nanfang Hospital, Southern Medical University
      • Guangzhou, Guangdong, China
        • Guangdong Second Provincial General Hospital
      • Guangzhou, Guangdong, China
        • Zhujiang Hospital, Southern Medical University
      • Zhuhai, Guangdong, China
        • the Fifth Affiliated Hospital of Zunyi Medical University
    • Shandong
      • Jinan, Shandong, China
        • Shandong Provincial Hospital Affiliated to Shandong University
    • Shanghai
      • Shanghai, Shanghai, China
        • Changhai Hospital
      • Shanghai, Shanghai, China
        • Shanghai Tongji Hospital, Tongji University School of Medicine
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • Sir Run Run Shaw Hospital
  • United Kingdom
      • Sheffield, United Kingdom
        • Sheffield teaching Hospitals NHS Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Participants with compensated cirrhosis

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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: Detachable string magnetically controlled capsule endoscopy
Esophagogastroduodenoscopy is performed 2 hours after the magnetically controlled capsule endoscopy (Ankon Medical Technologies Co. Ltd.).
Other Names:
  • Esophagogastroduodenoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 year
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
1 day
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
3 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanfang Hospital of Southern Medical University

Collaborators

Changhai Hospital
LanZhou University
Beijing 302 Hospital
Sheffield Teaching Hospitals NHS Foundation Trust
Shandong Provincial Hospital
Zhujiang Hospital
Third Affiliated Hospital, Sun Yat-Sen University
Shanghai Tongji Hospital, Tongji University School of Medicine
Guangdong Second Provincial General Hospital
The Fifth Affiliated Hospital of Zunyi Medical College
The Second Affiliated Hospital of Baotou Medical College
Sir Run Run Shaw Hospital, Medical College, Zhejiang University

Investigators

  • Principal Investigator: Xiaolong QI, M.D., LanZhou University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 9, 2018

Primary Completion (Actual)

December 3, 2019

Study Completion (Anticipated)

November 8, 2022

Study Registration Dates

First Submitted

November 17, 2018

First Submitted That Met QC Criteria

November 20, 2018

First Posted (Actual)

November 21, 2018

Study Record Updates

Last Update Posted (Actual)

November 17, 2020

Last Update Submitted That Met QC Criteria

November 13, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHESS1801

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Compensated Cirrhosis

Clinical Trials on Detachable string magnetically controlled capsule endoscopy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Gambia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe