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

• Conditions: Stomach Diseases; Small Intestine Disease
• Interventions: Other: UGI+SB

• Registration Number: NCT05069233
• Lead Sponsor: Changhai Hospital

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.

Study Timeline

• Status Verified: 2021-09
• Study First Submitted: 2021-09-17
• Study Start: 2021-09-27
• Study First Submitted QC: 2021-09-28
• Last Update Submitted: 2021-09-28
• Study First Posted: 2021-10-06
• Last Update Posted: 2021-10-06
• Primary Completion: 2021-12-28
• Study Completion: 2021-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 593

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
UGI+SB	UGI+SB	Patients who underwent combined upper digestive tract and small intestine examination under MCE.

Primary Outcome Measures

Name	Time	Method
Success rate of UGI and small-bowel examination	2 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Visualization of the esophagus	2 weeks	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.
Visualization score of the gastric mucosa	2 weeks	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).
Visualization of the small bowel	2 weeks	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%.
Detection rate of lesions	1 month	The detection rate of lesions in different digestive part (esophagus, stomach, duodenum, small intestine) found by MCE.
Examination time of esophagus, stomach, duodenum and small bowel	1 month	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.
Adverse events during MCE procedure	1 month	The presence of any adverse events during MCE procedure will be recorded.

Trial Locations

Locations (1)

Changhai Hospital; 🇨🇳 Shanghai, China