Clinical trial NCT04933643: Analysis of Influencing Factors of Gastric Preparation Quality for MCCG
Official title: Analysis of Influencing Factors of Gastric Preparation Quality for Magnetically Controlled Capsule Gastroscopy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Capsule Endoscopy
Keywords: Magnetically Controlled Capsule Gastroscopy
Influencing Factors
Gastric Preparation Quality
Lead sponsor: Shandong University
Sponsor class: OTHER
First posted: 2021-06-22
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients aged 18-75 years old who intend to undergo magnetron capsule gastroscopy, regardless of gender

Brief summary: The invention of magnetically controlled capsule gastroscopy makes the movement of capsule endoscope in the body controllable. Endoscopic doctors can adjust the angle of capsule observation to examine gastric mucosa according to the need of examination. However, The presence of food residue, air bubbles, mucus and bile in the gastric cavity will affect the observation of gastric mucosa by capsule endoscopy. it will reduce the completion rate of capsule endoscopy, and even lead to misdiagnosis and missed diagnosis. The purpose of this study is to explore the factors affecting the quality of gastroscopy gastric environmental preparation of magnetically capsule.

Detailed description: Magnetically controlled capsule endoscopy is different from ordinary electronic gastroenteroscopy, it can not fill and clean the gastric cavity by water injection. The presence of food residue, air bubbles, mucus and bile in the gastric cavity will affect the observation of gastric mucosa by capsule endoscopy, reduce the completion rate of capsule endoscopy, and even lead to misdiagnosis and missed diagnosis, so the quality of MCCG gastric environmental preparation is an important factor limiting the accuracy of diagnosis of gastric lesions. We design the case report table by consulting the literature, and then collect patient information, and speculate the relevant influencing factors through the evaluation of the quality of gastric environmental preparation of the examination results. the ultimate goal is to reduce the missed diagnosis rate and misdiagnosis rate and the waste of clinical resources, to prepare the gastric environment more pertinently, and to provide certain guiding significance for the preparation of gastric environment in clinical magnetically controlled capsule endoscopy.

Eligibility criteria: Inclusion Criteria:

* patients aged 18-75 years old who intend to undergo magnetron capsule gastroscopy, regardless of gender
* sign informed consent form

Exclusion Criteria:

* dysphagia, known or suspected gastrointestinal obstruction、stricture and fistula
* patients with severe somatic diseases unable to complete examination
* known active upper gastrointestinal bleeding
* previous history of upper digestive tract or abdominal surgery to change
* gastrointestinal anatomy
* patients with cardiac pacemakers or implanted with other electronic medical
* instruments and magnetic metal foreign bodies
* pregnant women
* claustrophobia or other mental disorders uncontrollable

Primary outcomes:
measure: GCS score was used to evaluate the quality of gastric preparation
timeFrame: 24 months
measure: Questionnaire data were used to analyze the influencing factors
timeFrame: 24 months
Secondary outcomes:
measure: The number of positive lesions
timeFrame: 24 months
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
timeFrame: 24 months
Other outcomes:
Locations:
city: Jinan
country: China
facility: Department of Gastroenterology, Qilu Hospital, Shandong University
state: Shandong
Study officials:
affiliation: Qilu Hospital, Shandong University
name: Li Yanqing
role: PRINCIPAL_INVESTIGATOR
References: