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Analysis of Influencing Factors of Gastric Preparation Quality for MCCG

S

Shandong University

Status

Enrolling

Conditions

Capsule Endoscopy

Study type

Observational

Funder types

Other

Identifiers

NCT04933643
2020SDU-QILU-072

Details and patient eligibility

About

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.

Full 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.

Enrollment

240 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

240 participants in 2 patient groups

well prepared
Description:
GCS was the total scores of all six land-marks, ranging from 6 (completely unprepared) to 24 (perfect). We define that the stomach is well prepared when GCS ≥ 18
inadequate prepared
Description:
GCS was the total scores of all six land-marks, ranging from 6 (completely unprepared) to 24 (perfect). We define that GCS \< 18 is inadequate.

Trial contacts and locations

1

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Central trial contact

Li Yanqing

Data sourced from clinicaltrials.gov

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