Analysis of Influencing Factors of Gastric Preparation Quality for MCCG

NCT ID: NCT04933643

Last Updated: 2023-02-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

240 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-06-22

Study Completion Date

2023-03-31

Brief Summary

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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

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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.

Conditions

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Capsule Endoscopy

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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well prepared

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

Intervention Type OTHER

inadequate prepared

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.

Intervention Type OTHER

Interventions

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Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Shandong University

OTHER

Sponsor Role lead

Responsible Party

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Yanqing Li

Vice president of QiLu Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Li Yanqing

Role: PRINCIPAL_INVESTIGATOR

Qilu Hospital, Shandong University

Locations

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Department of Gastroenterology, Qilu Hospital, Shandong University

Jinan, Shandong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Li Yanqing

Role: CONTACT

053182169385

Facility Contacts

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Yanqing Li, PhD. MD.

Role: primary

18678827666

Other Identifiers

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2020SDU-QILU-072

Identifier Type: -

Identifier Source: org_study_id

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