This study aims to evaluate the feasibility and safety of DS-MCE with a novel way for complete examination in UGI tract and small bowel, compared with EGD.
Magnetically controlled capsule endoscopy (MCE) has been widely used in clinical practice for upper gastrointestinal (UGI) tract and Small Bowel. However, the complete visualization of UGI tract still present challenges due to rapid transit through esophagus and duodenum, although technical improvements of MCE are helpful. Detachable String MCE (DS-MCE) can control the movement of MCE through the string and MCE can start next examination after string detachment, which was proved to be an effective and safe method for complete viewing of the esophagus and stomach. In order to improve the duodenum visualization, endoscopist separate MCE from the string after finishing UGI examination so that can inspect the esophagus, stomach and duodenum under the string and magnetic field control. This is a prospective, single-centered, self-controlled pilot study. Subjects with or without digestive symptoms receiving UGI endoscopy will be enrolled to take DS-MCE and conventional esophagogastroduodenoscopy (EGD) within 48h successively.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
25
The subjects swallowed the MCE to investigate the esophagus repeatedly by pulling up or down the string. After completion of the esophageal examination, MCE reached the stomach and was lifted away from the posterior wall, rotated if necessary and advanced to the fundus and cardiac regions, and then to the gastric body, angulus, antrum and pylorus. After finishing the stomach examination, the capsule would enter the duodenum due to peristalsis when the pylorus opened. Then DS-MCE tried to inspect the duodenum repeatedly under the string and magnetic field control, including view of major papilla in the descending part of duodenum and retrograde view of pylorus in duodenal bulb with a "360-degree automatic scanning" mode. After completion of the duodenum examination, the capsule started to view the small bowel.
Changhai Hospital
Shanghai, China
RECRUITINGSuccess rate of UGI and small-bowel examination
The feasibility of DS-MCE examination with a novel way is evaluated by the technical success rate, a composite outcome including the successful separation of the string and MCE, repeat viewing of esophagus, stomach and duodenum, and complete small-bowel examination.
Time frame: up to 2 weeks
Diagnostic accuracy
The diagnostic accordance rate, sensitivity and specificity of lesions detected by DS-MCE compared with EGD.
Time frame: up to 2 weeks
Safety of DS-MCE procedure: presence of any adverse events during DS-MCE procedure will be recorded
The presence of any adverse events during DS-MCE procedure will be recorded.
Time frame: up to 2 weeks
Detection rate of Z-line, duodenal papilla and pyloric retrograde view
The detection means that at least one image of anatomical structure was obtained.
Time frame: up to 2 weeks
Circumferential visualization of the Z-line and duodenal papilla
It is defined by quadrants as follows: less than 2 quadrants (\< 50%) observed; at least 2 quadrants (50%-75%) observed; at least 3 quadrants (\>75%) observed; and entire structure (100%) observed.
Time frame: up to 2 weeks
Cleansing level of Z-line and duodenal papilla area
The effect of bubbles/saliva on the appearance of the Z line or duodenal papilla area was both scored as follows: 0=no interference by bubbles/saliva;1=minor interference of bubbles/saliva; 2=major interference of bubbles/saliva.
Time frame: up to 2 weeks
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Visualization level of stomach
Visualization level of gastric primary anatomic landmarks: cardia, fundus, body, angulus, antrum and pylorus. (good, \>75% of mucosa was observed; moderate, 50% to 75% was observed; poor, \<50% of the gastric mucosa was observed)
Time frame: up to 2 weeks
Examination time of esophagus, stomach, duodenum and small bowel
Record the time taken to finish examination in different digestive part.
Time frame: up to 2 weeks
Pyloric transit time
Record the time from completion of the gastric examination to the capsule entering the duodenum.
Time frame: up to 2 weeks
Discomfort scores associated with DS-MCE
Discomfort caused by the string, swallowing the DS-MCE, pulling the capsule up or down, and pulling the string out were on a scale from 0 to 3 (0=none;1=mild/minimal; 2=moderate; and 3=severe/very difficult) according to the Ramirez system. Overall discomfort was scored on a scale of 0 to 10 (0=no discomfort; 10=the overall discomfort of EGD) according to our previous system.
Time frame: up to 2 weeks
Image quality scores
Assess Image quality grade ranged from 1 to 10 (1, the worst quality; 10, the quality of the best image captured by EGD).
Time frame: up to 2 weeks
Detection rate of lesions
The detection rate of lesions in different digestive part (esophagus, stomach, duodenum, jejunoileum) found by MCE.
Time frame: up to 2 weeks