The aim of this study is to evaluate the clinical application of the second-generation MCCG with higher image resolution and frame rate for upper gastrointestinal tract compared with the first-generation.
Magnetically controlled capsule gastroscopy (MCCG) has been widely used in clinical practice for gastric examination. However, there still exist blind spots under MCCG, particularly in the esophagus and duodenum. Although the anatomy of the esophagus and duodenum can be the main cause, MCCG still needs technical improvement. In addition, the gastric examination time under MCCG can be further optimized. Therefore, a new-generation MCCG is developed with a higher frame rate improved from 0.5-2 to 0.5-8 frames per second, image resolution improved from 480 x 480 to 720 x 720, view angle improved from 140° to 150°, wireless anti-jamming technology is applied as a more effective and stable information transmission method. This is a prospective, single-centered, blinded randomized controlled pilot study. Subjects receiving MCCG at Changhai Hospital will be randomly allocated into two groups with a ratio of 1:1 before the procedure, the first-generation or the second-generation MCCG. After passage through the esophagus, the gastric examination and transpyloric passage of the capsule is conducted under magnetic steering, and then examination is continued in the small bowel under intestinal peristalsis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Enrollment
80
Patients in the experimental group swallowed the second-generation MCCG (Ankon Navicam-2).
Changhai Hospital
Shanghai, China
Circumferential Visualization of the Z-line
Circumferential visualization of the Z-line is defined by quadrants as follows: less than 2 quadrants (\< 50%) of the Z line observed; at least 2 quadrants (50%-75%) observed; at least 3 quadrants (\>75%) observed; and entire Z line (100%) observed.
Time frame: Through end of examination, up to 30 minutes
Detection Rate of Duodenal Papilla
Detection rate of duodenal papilla means the percentage of patients with at least one image of duodenal papilla was obtained
Time frame: up to 2 days after the examination
Gastric Examination Time (GET)
Record the time taken for endoscopist to finish the gastric examination for primary anatomical landmarks twice (cardia, fundus, body, angulus, antrum and pylorus).
Time frame: Through end of examination, up to 30 minutes
Manipulation Performance Score of the MCCG
The performance of maneuverability is assessed using a semi-quantitative score related to the fluency, stability and comfortableness for examination procedure. Fluency is mainly reflected on the response speed to operation and smoothness of video playing. Stability is about the ability of holding the position for a long enough time and the real-time viewing of all images. comfortableness is the operator's sensation about manipulative force and fatigue degree. Maneuverability score was defined as a total scale of 3 to 15 calculated by adding up each evaluation index score above, and each index was graded from 1 to 5, with 1 as the worst and 5 as the best.
Time frame: up to 10 minutes after the examination
Image Quality Score (Mainly Focus on Clarity)
Assess Image quality grade ranged from 1 to 10 (1, the worst quality; 10, the quality of the best image captured by EGD).
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Time frame: up to 30 minutes after the examination
The Number of Images Captured for Esophagus and Z-line
The number of images captured by MCCG for esophagus and Z-line.
Time frame: up to 30 minutes after the examination
Number of Participants With Lesions in Upper Gastrointestinal Tract
calculate the number of participants with lesions in different part of upper gastrointestinal tract (esophagus, stomach, duodenum, jejunoileum), and preliminarily evaluate the diagnostic efficacy of the new-generation MCCG.
Time frame: up to 2 days after the examination
Transit Time of MCCG in the Gastrointestinal Tract and Total Running Time
Assess the transit time of MCCG in the gastrointestinal tract (stomach and small bowel), and record the total running time from starts take images to ends.
Time frame: up to 2 days after the examination
Cleansing Level Score of Z-line Area
The bubbles/saliva on the Z line area will be scored as follows: 0 = no bubbles/saliva on the Z line area;1 = a few bubbles/saliva on the Z line area; 2= increased amount of bubbles/saliva on the Z line area; 3 = severe bubbles/saliva on the Z line area.
Time frame: Through end of examination, up to 30 minutes
The Incidence of Adverse Events (The Safety of MCCG)
The presence of adverse events within two weeks aftter swallowing MCCG will be recorded.
Time frame: up to 2 weeks after the examination
Transit Time of MCCG in Esophagus
Assess the transit time of MCCG in esophagus from starts take images to ends.
Time frame: up to 2 days after the examination