Clinical trial NCT03749954: Detachable String Magnetically Controlled Capsule Endoscopy for Detecting High-risk Varices in Compensated Cirrhosis
Official title: Detachable String Magnetically Controlled Capsule Endoscopy for Detecting High-risk Varices in Compensated Advanced Chronic Liver Disease (CHESS1801): A Prospective Multicenter Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Compensated Cirrhosis
Gastroesophageal Varices Bleeding
Keywords: Magnetically controlled capsule endoscopy
Gastroesophageal varices bleeding
Varices needing treatment
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
Collaborators: name: Beijing 302 Hospital
name: Sir Run Run Shaw Hospital
name: Zhujiang Hospital
name: Shandong Provincial Hospital
name: Shanghai Tongji Hospital, Tongji University School of Medicine
name: Third Affiliated Hospital, Sun Yat-Sen University
name: Guangdong Second Provincial General Hospital
name: The Fifth Affiliated Hospital of Zunyi Medical College
name: LanZhou University
name: Sheffield Teaching Hospitals NHS Foundation Trust
name: Changhai Hospital
name: The Second Affiliated Hospital of Baotou Medical College
First posted: 2018-11-21
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with compensated cirrhosis

Brief summary: 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.

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.

Eligibility 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.

Primary outcomes:
measure: Diagnostic accuracy of magnetically controlled capsule endoscopy for the risk of variceal bleeding
timeFrame: 1 day
Secondary outcomes:
measure: Diagnostic accuracy of magnetically controlled capsule endoscopy for decompensation or death
timeFrame: 3 year
measure: Diagnostic accuracy of other non-invasive methods for the risk of variceal bleeding
timeFrame: 1 day
measure: Diagnostic accuracy of other non-invasive methods for decompensation or death
timeFrame: 3 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: The Fifth Medical Center of PLA General Hospital
state: Beijing
city: Lanzhou
country: China
facility: The First Hospital of Lanzhou University
state: Gansu
city: Guangzhou
country: China
facility: Guangdong Second Provincial General Hospital
state: Guangdong
city: Guangzhou
country: China
facility: Nanfang Hospital, Southern Medical University
state: Guangdong
city: Guangzhou
country: China
facility: Zhujiang Hospital, Southern Medical University
state: Guangdong
city: Zhuhai
country: China
facility: The Fifth Affiliated Hospital of Zunyi Medical University
state: Guangdong
city: Jinan
country: China
facility: Shandong Provincial Hospital affiliated to Shandong University
state: Shandong
city: Shanghai
country: China
facility: Changhai Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Tongji Hospital, Tongji University School of Medicine
state: Shanghai
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital
state: Zhejiang
city: Baotou
country: China
facility: The Second Affiliated Hospital of Baotou Medical College
city: Guangzhou
country: China
facility: Third Affiliated Hospital of Sun Yat-sen University
city: Sheffield
country: United Kingdom
facility: Sheffield Teaching Hospitals NHS Trust
Study officials:
affiliation: LanZhou University
name: Xiaolong Qi, M.D.
role: PRINCIPAL_INVESTIGATOR
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