Accuracy of Magnetically Maneuvered Capsule Endoscopy for Detection of EGV in Patients With Cirrhosis

Naval Military Medical University

Status: Completed

Conditions: Portal Hypertension; Esophageal Varices; Liver Cirrhosis; Gastric Varix

Treatments: Diagnostic Test: ds-MCE and EGD

Study type: Interventional

Funder types: Other

Identifiers

NCT03748563

CENTERS

Details and patient eligibility

About

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.

Full description

Cirrhosis is the major cause of liver disease-related morbidity and mortality worldwide. Portal hypertension (PH) is the hemodynamic abnormality in patients with cirrhosis, which is associated with various pathological changes throughout the entire gastrointestinal tract, manifesting as esophagogastric varices (EGV), portal hypertensive gastropathy (PHG), and portal hypertensive enteropathy (PHE). Baveno consensus and other practice guidelines recommended that patients with cirrhosis undergo endoscopic screening for EGV at the time of diagnosis and undergo periodic surveillance endoscopy throughout the whole course of cirrhosis.

Esophagogastroduodenoscopy (EGD) is recognized as the gold standard for detection and follow-up of EGV in cirrhotic patients, allowing for direct mucosal visualization and therapeutic intervention. EGD is however an invasive procedure and there is potential for procedure-related complications, such as perforation and bleeding. Besides, conscious sedation is always required, leading to increased cost, risk, and inconvenience for the patients.These factors lead to a decrease of patient compliance as well as the effectiveness of the screening program.

The capsule endoscopy (CE) system provides a noninvasive and relatively comfortable approach to visualize the GI tract, and the development of esophageal capsule endoscopy (ECE) makes it possible to capture clear images of esophagus without the need of sedation. However, the accuracy of ECE is not currently sufficient to replace EGD for the detection and grading for the esophageal varices. Besides, previous studies presented that the sensitivity of ECE for detecting gastric varices (GVs) and PHG varies from 3% to 69%, which denoted ECE was far from a suitable alternative for diagnosing gastric lesions.

To overcome these limitations, a new technique, so-called detachable string magnetically maneuvered capsule endoscopy (ds-MCE) was developed. The ds-MCE system consists of two parts: the magnetically maneuvered capsule endoscopy (MCE) system and a transparent latex sleeve with a hollow string. One end of the hollow string is a transparent thin latex sleeve that can be wrapped on the surface of the capsule, and the other end of the string is connected to the syringe. The capsule, which is partially enclosed within the sleeve, can be actively moved in the esophagus through the control of string. In this case, investigator can examine the entire esophageal mucosa several times under real time views. The capsule then can be detached from the string system through injecting air into the hollow string with the syringe after completing the examination of esophagus. The magnetic capsule in the stomach can be accurately controlled through multidimensional rotation and adaptive matching of an external C-arm robot. Previous studies have demonstrated that the diagnostic accuracy of MCE for detecting gastric focal lesions is comparable with that of conventional EGD. Two previously studies of ds-MCE confirmed it was a feasible, safe and well-tolerated method for completely viewing esophagus and stomach, without the need for sedation. Besides, the 8-10h battery life of the ds-MCE enables complete examination of the small bowel, which enables to provide a more comprehensive evaluation of gastrointestinal changes.

Considering all these backgrounds, in the current prospective study, the primary aim is to assess the diagnostic performance of the ds-MCE in identifying the presence of EGV in cirrhotic patients, using EGD as the reference standard. 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.

Enrollment: 607 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Gender is not limited.
2. Patients aged 18 years or older.
3. Both inpatients and outpatients.
4. Clinically evident or biopsy-proven liver cirrhosis.
5. Able to provide informed consent.

Exclusion criteria

1. Patients aged less than 18 years.
2. Patients with Zenker's diverticulum.
3. Patients with active gastrointestinal bleeding.
4. Patients who have participated in or are participating in other clinical trials.
5. Pregnancy or suspected pregnancy.
6. Suspected or known intestinal stenosis or other known risk factors for capsule retention.
7. Pacemaker or other implanted electromedical devices which could interfere with magnetic resonance.
8. Patients with dysphagia.
9. Life-threatening conditions.
10. Patients plan to undergo magnetic resonance imaging examination before excretion of the MCE.
11. Patients who refuse to give informed consent.
12. Patients with any condition that precludes compliance with the study.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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607 participants in 1 patient group

ds-MCE and EGD

Experimental group

Description:

All the enrolled participants will undergo the examination of detachable string magnetically maneuvered capsule endoscopy (ds-MCE) first, followed by EGD within 48 hours.

Treatment:

Diagnostic Test: ds-MCE and EGD