Esophageal and Gastric Diseases With Robotically Controlled Magnetic Capsule Endoscopy

Study Overview
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Brief Summary
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Magnetically controlled capsule endoscopy (MCCE) is an outstanding opportunity for the painless endoscopic screening of the esophagus and stomach before small bowel examiantion. Further improvement in patients positioning might increase the esophageal transit time of the capsule endoscope and could improve the sensitivity and specificity of the esophageal MCCE investigation. Our present study aimed to compare the visualization of the esophagus (especially the Z-line) with different capsule swallowing protocols.

Detailed Description
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Magnetic controlled capsule endoscope (MCCE) systems have been developed over the last 10-15 years to examine the upper GI tract, particularly the stomach. The new Navicam MACE system consists of a magnetic capsule endoscope, an external control magnet, a data recording kit and a computer workstation. With the appropriate software, allows real-time tracking and monitoring of the capsule inside the body. This method may in the near future be an optimal non-invasive method for screening gastric cancer and Barrett's oesophagus in high-risk populations. Esophagogastroduodenoscopy (EGD) is the gold standard diagnostic test, however it is very inconvenient for patients without sedation. The aim of our present study was a feasibility study to evaluate the safety and efficacy of Ankon MCCE for the investigation of esophageal abnormalities in patients referred for small bowel capsule endoscopy in our endoscopy department, to develop and test a method to use MCCE for esophageal examination, and to analyze the visualization of esophageal mucosa with our newly developed capsule swallowing protocol and manual capsule maneuvering.

Official Title
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Study of Esophageal and Gastric Diseases With Robotically Controlled Magnetic Capsule Endoscopy

Conditions
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Video Capsule Endoscopy, Esophageal Diseases

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - patients referred for small bowel capsule endoscopy in any indication Exclusion Criteria: known or suspected stricture in the GI tract previous surgery with bowel anastomosis swallowing complaints dementia implanted cardioverter defibrillator inability to sign the informed consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Capsule endoscopy patients<br>Patients swallowed the capsules in left lateral position, leaning on their left forearms and elbows, while we were positioning the magnet tightly against their backs. With the magnetic field vector X,Y,Z axis 180, -90 and 90, respectively. After swallowing the capsules with a small amount of water, they remained in this left lateral decubitus position. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reflux esophagitis | Proportion and the severity of reflux (Los Angeles classification) comparing to gastroscopy | 1 year | 
| Diseases | Proportion of other disorders of oesophagus and stomach comparing to gastroscopy | 1 year | 
| Stomach examination | Analyze the visualisation of gastric mucosa with MACE system | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Restrain time | Analysing the correlation with MCCE system between esophageal transit time and diagnostic yield. | 1 year | 
| Cleanliness | Analysis of stomach preparation with a special software concerning the percentage of clean and covered areas. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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capsule endoscopy, magnetically assisted capsule endoscopy, MCCE, Esophagus, non-invasive endoscopy