Accuracy of Magnetically Maneuvered Capsule Endoscopy for Detection of EGV in Patients With Cirrh… (NCT03748563) | Clinical Trial Compass
CompletedNot Applicable
Accuracy of Magnetically Maneuvered Capsule Endoscopy for Detection of EGV in Patients With Cirrhosis
China607 participantsStarted 2021-01-07
Plain-language summary
This is a diagnostic accuracy study. Eligible individuals will be enrolled and asked to undergo ds-MCE and EGD examinations. EGD is the reference standard against which ds-MCE is compared, and it will be performed within 48 hours after ds-MCE examination. The primary outcome is the sensitivity and specificity of ds-MCE in identifying the presence of esophagogastric (EGV) in patients with cirrhosis, using detection by EGD as the reference. The diagnostic accuracy of ds-MCE in detection of high-risk EV, high-risk EGV, EV, large EV, red signs of EV, GV, cardiofundal GV and PHG compared with the EGD will also be assessed. The incidence of PHE in small bowel under ds-MCE, the examination time of ds-MCE and EGD procedures, patient satisfaction assessment and safety evaluation will also be evaluated.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Gender is not limited.
✓. Patients aged 18 years or older.
✓. Both inpatients and outpatients.
✓. Clinically evident or biopsy-proven liver cirrhosis.
✓. Able to provide informed consent.
Exclusion criteria
✕. Patients aged less than 18 years.
✕. Patients with Zenker's diverticulum.
✕. Patients with active gastrointestinal bleeding.
✕. Patients who have participated in or are participating in other clinical trials.
✕. Pregnancy or suspected pregnancy.
✕. Suspected or known intestinal stenosis or other known risk factors for capsule retention.
What they're measuring
1
the diagnostic accuracy of the ds-MCE in identifying the presence of esophagogastric varices (EGV)