An observational study in Stomach Diseases and Small Intestine Disease, sponsored by Changhai Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-10-06.
Sponsored by Changhai Hospital · Observational
In this study, we retrospectively analyzed the videos of combined upper digestive tract and small intestine examination under MCE, so as to clarify the feasibility and diagnostic efficacy of MCE in one-time examination of the upper gastrointestinal and small intestinal mucosa.
Magnetically controlled capsule endoscopy (MCE), with equally favorable diagnostic accuracy as conventional endoscopy, has become a painless noninvasive diagnostic modality in clinical practice. The more than 8 hours battery life of the MCE enables a further examination of the small bowel. In addition, it has been demonstrated that magnetic steering of capsule endoscopy improves the completion rate of small bowel examination by facilitating passage of the capsule through the pylorus, which further supported MCE as a practical modality for examination of both the stomach and small bowel. In this study, we retrospectively analyzed the videos of combined upper digestive tract and small intestine examination under MCE, so as to clarify the feasibility and diagnostic efficacy of MCE in one-time examination of the upper gastrointestinal and small intestinal mucosa.
50 studies on the registry are indexed under Stomach Diseases; 7 are open to participants now.
This study's planned enrollment of 593 is above the median of 397 across 12 observational studies indexed under Stomach Diseases.
Browse Stomach Diseases studies →Changhai Hospital is the lead sponsor of 342 studies on the registry; 133 are open to participants now.
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Patients who underwent upper gastrointestinal and small intestinal mucosal examination under MCE at Shanghai Changhai Hospital and Chinese PLA General Hospital after January 2020.
Exclusion Criteria:
Patients who underwent combined upper digestive tract and small intestine examination under MCE.
Other: UGI+SB
Patients who underwent combined upper digestive tract and small intestine examination under MCE.
Success rate of UGI and small-bowel examination
The success rate of upper gastrointestinal tract and small-bowel examination under MCE is evaluated by the technical success rate, a composite outcome including the successful viewing of esophagus, stomach and duodenum, and complete small-bowel examination.
Time frame: 2 weeks
Visualization of the esophagus
Visualization of the esophagus indicated by the number of images captured for Z-line and how many quadrants of the Z-line were observed. Circumferential visualization of the Z-line 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: 2 weeks
Visualization score of the gastric mucosa
Visualization score of the gastric mucosa To objectively evaluate the complete visualization of the gastric mucosa in the 6 anatomic landmarks (cardia, fundus, body, angulus, antrum, and pylorus), a 3-point grading scale was used: 1, poor (\<70% of the mucosa was observed), 2, fair (70%-90% of the mucosa was observed), and 3, good (\>90% of the mucosa was observed).
Time frame: 2 weeks
Visualization of the small bowel
Visualization of the small bowel was determined by the percentage of time during which the small-bowel view was clear, defined as not obscured more than 50% of the screen view. The clear-viewing percentage of the total small-bowel transit time assessed by a 4-point scale :0, less than 25%; 1, 25% to 49%; 2, 50% to 75%; and 3, greater than 75%.
Time frame: 2 weeks
Examination time of esophagus, stomach, duodenum and small bowel
Examination-related parameters included esophageal transit time (ETT), gastric examination time (GET), gastric transit time (GTT), pylorus transit time (PTT), small bowel transit time (SBTT). ETT is defined as the time between the first esophageal image and the first gastric image. GTT is defined as the time between the first gastric image and the first duodenal image. GET is defined as the time for examination of gastric primary anatomic landmarks twice. PTT is defined as the time between the first pyloric image and the first duodenal image. SBTT is defined as the time between the first duodenal image and the first cecal image.
Time frame: 1 month
Detection rate of lesions
The detection rate of lesions in different digestive part (esophagus, stomach, duodenum, small intestine) found by MCE.
Time frame: 1 month
Adverse events during MCE procedure
The presence of any adverse events during MCE procedure will be recorded.
Time frame: 1 month
Plan to share: No
This study is status unknown, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
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Changhai Hospital