A New Method To Reduce Gastric Missing Areas in Capsule Endoscopy

Study Overview
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Brief Summary
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It is a single center, prospective and self-controlled trial. We'd like to explore a new method by changing position to reduce gastric missing areas in Capsule Endoscopy(CE)

Detailed Description
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Background:Capsule endoscopy is widely used to observe small intestine.While it may miss important areas in stomach，especially in fundus.So far,physicians have no methods to observe stomach without no-missing areas by capsule endoscopy. Objective:To explore a new method to reduce the areas missed by CE. Methods:Subjects were prospectively enrolled.Every subjects will undergo 2 capsule endoscopies and 1 gastroscope.First capsule endoscopy,every subject have a better gastric preparation before swallowing CE and change position during the procedure.Second capsule endoscopy,every subject have a conventional CE. And then, every subject have a gastroscope. Measurements:The primary measurements included safety, gastric preparation, visualization of gastric mucosa and rate of lesion detection.

Official Title
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A New Method To Reduce Gastric Missing Areas in Capsule Endoscopy: a Single Center, Prospective and Self-controlled Trial

Conditions
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Capsule Endoscopy

Intervention / Treatment
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* Behavioral: Position changing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects don't have swallowing difficulties, motility disorders, or a medical history that included abdominal surgery or obvious gastrointestinal strictures are included. Exclusion Criteria: Subjects with swallowing difficulty, motility disorders, diabetes, life-threatening conditions, mental disorders, or patients that could be pregnant, have a cardiac pacemaker, electrical implant, or any other condition that would preclude compliance with the study requirements and/or device instructions are excluded from the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: position changing<br>During the examination, subjects changed position in the following sequence: left lateral head-down position, supine position, prone head-down position, right lateral head-down position, supine position, left lateral position, prone position, prone hip-high position, right lateral position and sitting position. | Behavioral: Position changing<br> <br> |
| No Intervention: free position<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| visualization of gastric mucosa | Gastric preparation included the degree of cleanliness and distention.Cleanliness was evaluated by 3 grades: good (the fluid was transparent and <5% of gastric mucosa was obscured by stomach contents), moderate (the fluid was a little opaque or 5% to 10% of gastric mucosa was obscured by stomach contents) and poor (the fluid was opaque or >10% of gastric mucosa was obscured by stomach contents). Distention was evaluated by 3 grades: good (existence of a small amount of gastric folds), moderate (existence of significant amount of gastric folds and gastric cavity was smaller than expected) and poor (gastric cavity was not inflated). | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rate of lesion detection | Gastroscope is the golden standard in diagnosing gastric diseases.we defined rate of lesion detection as the lesions detected by CE compared to gastroscope. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Capsule endoscopy, Patient position changing