MCE for Gastric Examination in Obese People

Changhai Hospital300 enrolled

Overview

This retrospective study aimed to evaluate the feasibility and safety of MCE for the detection of gastric disease in obese people.

In this study, we evaluated the feasibility and safety of MCE for the detection of gastric disease in obese people by comparing the results of MCE between healthy weight people (18.5≤BMI\<25) and obese people (BMI≥30). The observation index included mucosal visualization, gastric transit time, cleanliness of the stomach, detection of lesions and safety evaluation.

Study Type

OBSERVATIONAL

Enrollment

300

Conditions

Obesity

Interventions

MCEDEVICE

underwent MCE examination

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * 18.5≤BMI\<25 or BMI≥30 * underwent gastric examination; * At least 18 years old； * Be able to provide informed consent. Exclusion Criteria: * With swallowing obstruction or disorders; * With known or suspected gastrointestinal obstruction, stenosis and fistula; * Have no conditions for surgery or refuse to undergo any abdominal surgery; * Be allergic to or have other known contraindication or intolerance to the drug used in the study; * With pacemakers or other electronic devices such as electronic cochlear implants, implanted magnetic metal drug infusion pumps, neurostimulators, and magnetic metal foreign bodies; * Women during pregnancy; * Currently enrolled in another clinical trial of a drug or device; * Other conditions determined by the investigator to be inappropriate for enrollment.

Locations (1)

Changhai Hospital

Shanghai, Shanghai Municipality, China

Outcomes

Primary Outcomes

the degree of gastric mucosal visualization

The overall observational integrity of the gastric mucosa is based on the evaluation of the mucosal visualization of several key anatomical sites in the stomach: cardia, fundus, gastric body, gastric horn, gastric antrum and pylorus. The evaluation criteria for mucosal visualization of each site are: good : adequate observation, ≥90% of the gastric mucosa can be observed; fair : good observation, 70-90% of the gastric mucosa can be observed; poor : inadequate observation, \<70% of the gastric mucosa can be observed.

Time frame: 2 weeks

Secondary Outcomes

the cleanliness of the stomach

The criteria for judging the cleanliness of the stomach are: excellent : no adhesive mucus and foam, clear field of view; good : a small amount of mucus and foam, but the field of view is not blurred and does not affect the integrity of the examination; average : medium amount of mucus and foam, the field of view is more blurred and affects the integrity of the examination; poor : a large amount of mucus and foam, the field of view is blurred and affects the integrity of the examination.

Time frame: 2 weeks

Stomach transmit time

The time of the first stomach image, the first small intestine image and the last image taken by capsule endoscopy were recorded. Stomach transmit time: time of first small intestine image minus time of first stomach image.

Time frame: 2 weeks

Small bowel transmit time

The time of the first large intestine image minus the time of the first small intestine image.

Time frame: 2 weeks

Incidence of adverse events

The rates of adverse events such as asphyxia by capsule aspiration, swallow disorder, retention, technical failure, and procedural adverse events were recorded.

Central Contacts

Zhuan Liao

CONTACT

86-21-31161004 liaozhuan@smmu.edu.cn

Data from ClinicalTrials.gov

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