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Magnetically Controlled Capsule Endoscopy in Visualization of the UGI and Small Intestine

Feasibility of the Magnetically Controlled Capsule Endoscopy in One Time Visualization of the Upper Gastrointestinal Tract and Small Intestine

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05069233
Enrollment
593
Registered
2021-10-06
Start date
2021-09-27
Completion date
2021-12-30
Last updated
2021-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Small Intestine Disease, Stomach Diseases

Keywords

capsule endoscopy

Brief summary

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.

Detailed description

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.

Interventions

OTHERUGI+SB

Patients who underwent combined upper digestive tract and small intestine examination under MCE.

Sponsors

Chinese PLA General Hospital
CollaboratorOTHER
Changhai Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

1. Age ≥ 18 years old. 2. Those who underwent upper gastrointestinal and small intestinal mucosal examination under magnetically controlled capsule endoscopy at Shanghai Changhai Hospital and Chinese PLA General Hospital after January 2020. 3. Able to provide informed consent.

Exclusion criteria

1. Patients who fail to follow the prescribed procedures for magnetically controlled capsule endoscopy; 2. Patients who only undergo gastric examination under magnetically controlled capsule endoscopy; 3. Patients who only undergo small bowel examination under magnetic control capsule endoscopy; 4. The patient's basic information in the database is incomplete; 5. Patient fail to be followed up.

Design outcomes

Primary

MeasureTime frameDescription
Success rate of UGI and small-bowel examination2 weeksThe 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.

Secondary

MeasureTime frameDescription
Visualization score of the gastric mucosa2 weeksVisualization 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).
Visualization of the small bowel2 weeksVisualization 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%.
Visualization of the esophagus2 weeksVisualization 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.
Detection rate of lesions1 monthThe detection rate of lesions in different digestive part (esophagus, stomach, duodenum, small intestine) found by MCE.
Adverse events during MCE procedure1 monthThe presence of any adverse events during MCE procedure will be recorded.
Examination time of esophagus, stomach, duodenum and small bowel1 monthExamination-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.

Countries

China

Contacts

Primary ContactZhuan Liao, Professor
zhuanleo@126.com(81)02131161024
Backup ContactXi Jiang, PhD
jiangxi_stella@126.com81-13127952352

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026