An observational study in Compensated Cirrhosis and Gastroesophageal Varices Bleeding, sponsored by Nanfang Hospital, Southern Medical University. Status unknown at 13 sites in 2 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2020-11-17.
Sponsored by Nanfang Hospital, Southern Medical University · Observational
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.
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.
1,642 studies on the registry are indexed under Liver Cirrhosis; 358 are open to participants now.
This study's enrollment of 105 is below the median of 151 across 587 observational studies indexed under Liver Cirrhosis.
Browse Liver Cirrhosis studies →Nanfang Hospital, Southern Medical University is the lead sponsor of 480 studies on the registry; 212 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Participants with compensated cirrhosis
Exclusion Criteria:
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.).
Also known as: Esophagogastroduodenoscopy
Diagnostic accuracy of magnetically controlled capsule endoscopy for the risk of variceal bleeding
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
Time frame: 1 day
Diagnostic accuracy of magnetically controlled capsule endoscopy for decompensation or death
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
Time frame: 3 year
Diagnostic accuracy of other non-invasive methods for the risk of variceal bleeding
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
Time frame: 1 day
Diagnostic accuracy of other non-invasive methods for decompensation or death
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
Time frame: 3 year
Plan to share: Undecided — Undecided
This study is status unknown, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Nanfang Hospital, Southern Medical University