Accuracy of Magnetically Maneuvered Capsule Endoscopy for Detection of GEV in Patients With Cirrhosis
Accuracy of Magnetically Maneuvered Capsule Endoscopy for Detection of GEV in Patients With Cirrhosis
This is a non-interventional diagnostic accuracy study. Using EGD as the golden standard, to
 assess the accuracy of the ds-MCE in identifying and grading gastroesophageal varices in
 patients undergoing screening or surveillance for gastroesophageal varices. And the efficacy
 of the ds-MCE in detecting various pathological changes of cirrhosis in small bowel will be
 assessed as well.
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 gastroesophageal varices, portal hypertensive gastropathy (PHG), and portal
 hypertensive enteropathy (PHE). Baveno consensus and other practice guidelines recommended
 that all patients with cirrhosis undergo endoscopic screening for varices 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 gastroesophageal varices 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. 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 esophageal disease without the need for sedation. However, ECE was
 reported to have variable sensitivity and was not accurate enough to replace EGD in
 diagnosing or grading 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
 controlled capsule endoscopy (ds-MCE) was developed. The ds-MCE system consists of two parts:
 the magnetically controlled capsule endoscopy (MCE) system and a transparent latex sleeve
 with a hollow string. The magnetically controlled capsule endoscopy (MCE) system (Ankon
 Technologies, Shanghai, China) detects focal lesions in the stomach with comparable accuracy
 with conventional EGD. 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 could be
 detached from the string system through injecting air into the hollow string with the syringe
 after completing the examination of esophagus. The pilot study 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 provides the possibility for screening pathological
 changes in the entire gastrointestinal tract.

 Considering all these backgrounds, in the current prospective study, the primary aim is to
 assess the diagnostic yield of the ds-MCE in identifying the presence of gastroesophageal
 varices in LC patients using EGD as the golden standard. The secondary aim is to assess the
 accuracy of ds-MCE in grading esophageal varices (EV), identifying high-risk EVs, gastric
 varices and portal hypertensive gastropathy (PHG) in LC patients using EGD as the gold
 standard, and to define the mucosal abnormalities of portal hypertensive enteropathy (PHE).
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, without previous diagnosis of
 gastroesophageal varices but with clinical indication for screening endoscopy for the
 detection of varices, or with prior endoscopic diagnosis of gastroesophageal varices
 and indication for surveillance endoscopy.

 5. Able to provide informed consent.

 Exclusion Criteria:

 1. Patients aged less than 18 years.

 2. Patients with active upper gastrointestinal bleeding.

 3. Patients who have participated in or are participating in other clinical trials within
 three months.

 4. Patients with cancer on active treatment with chemotherapy and/or radiation therapy.

 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 who refuse to undergo or can't tolerate EGD.

 11. Patients whose consents for removal of remained ds-MCE are unable to be obtained.