Clinical trial NCT04068480: Esophageal and Gastric Diseases With Robotically Controlled Magnetic Capsule Endoscopy
Official title: Study of Esophageal and Gastric Diseases With Robotically Controlled Magnetic Capsule Endoscopy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Video Capsule Endoscopy
Esophageal Diseases
Keywords: capsule endoscopy
magnetically assisted capsule endoscopy
MCCE
Esophagus
non-invasive endoscopy
Lead sponsor: Bács-Kiskun County Teaching Hospital
Sponsor class: OTHER
First posted: 2019-08-28
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Every patient who met the eligibility criteria and had MCCE examination with esophageal protocol.

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Reflux esophagitis
timeFrame: 1 year
measure: Diseases
timeFrame: 1 year
measure: Stomach examination
timeFrame: 1 year
Secondary outcomes:
measure: Restrain time
timeFrame: 1 year
measure: Cleanliness
timeFrame: 1 year
Other outcomes:
Locations:
city: Székesfehérvár
country: Hungary
facility: Endo-Kapszula Privat Medical Cenbter
Study officials:
affiliation: Bács-Kiskun County Teaching Hospital
name: László Madácsy, Prof.
role: PRINCIPAL_INVESTIGATOR
References: