Capsule Endoscopy Clinical Trial
Official title:
Feasibility of Using Magnetically-controlled Capsule Endoscopy for Direct Visualization of Drug Behavior in Upper-gastrointestinal Tract
The investigators aim to explore the feasibility of MCE in direct, real-time visualization of drug behavior in upper-gastrointestinal tract, which presented by the adhesion, distribution, and dissipation characteristics of dyed sucralfate gel.
This pilot study was a prospective, single-centered, nonrandomized study. The investigators
selected 10 subjects from patients with a recent history of upper-gastrointestinal symptoms
who met the indication of taking sucralfate suspension gel, and another 10 subjects from
healthy volunteers.
Procedures were performed by the NaviCam magnetic capsule guidance system. To enhance
discrimination, the sucralfate gel dyed with 0.3 ml methylene blue. The subjects swallowed
the capsule with water in the left lateral position. When capsule enter stomach cavity,
subject was asked to sit up and ingested 4 g aerogenic powder with 5 ml water to distend the
stomach, and performed gastric baseline examinations to identify the lesions. After baseline
examination, subjects ingested dyed sucralfate gel and performed the first-time examination.
The examination was repeated at 30 min intervals, until dyed sucralfate gel disappeared
completely. When study completed, the capsule was detached from string and continued into the
small bowel for further examination.
The endoscopists recorded the adhesion and dissipation times of dyed sucralfate gel,
calculated the efficient time, and selected the images of six primary anatomic landmarks from
each examination to measure the distribution area (%) . Any complication or discomfort during
the procedure was evaluated. The discomfort was scored on a scale from 0 to 3 (0 = no; 1 =
mild/minimal; 2 = moderate; 3 = sever/very difficult).
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