Analysis of Influencing Factors of Gastric Preparation Quality for MCCG

NCT04933643 | Unknown

• 1 other identifier: 2020SDU-QILU-072
• Study Type: observational
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Capsule Endoscopy

Keywords

Magnetically Controlled Capsule Gastroscopy; Influencing Factors; Gastric Preparation Quality

Outcome Measures

Primary Outcomes (2)

• GCS score was used to evaluate the quality of gastric preparation

  GCS score was used to evaluate the quality of gastric preparation. GCS was defined as the sum of the scores of six major anatomical markers of the stomach (heart, fundus, body, horn, sinus, and pylorus).A 4-point grading system was used to define cleanliness as excellent (no mucus and foam attachment :4 points);Good (there is a small amount of mucus and foam, but it does not affect the test: score 3 points);Average (with a fair amount of mucus or foam).Failure to complete a completely reliable examination :2 points);Poor (large amount of mucus or foam residue :1 point).The GCS is the total score for all six landmarks, ranging from 6 (completely unprepared) to 24 (perfect).Gastric preparation was defined as sufficient when GCS≥18 and insufficient when GCS\<18.

  24 months

• Questionnaire data were used to analyze the influencing factors

  Before the examination, the subjects were required to fill in a questionnaire about the influencing factors of the quality of stomach preparation. According to GCS, the subjects were divided into fully prepared group and inadequately prepared group. Finally, statistical analysis was used to find the influencing factors that had statistical significance with the quality of stomach preparation according to the questionnaire content.

  24 months

Secondary Outcomes (2)

• The number of positive lesions

  24 months

• Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

  24 months

Study Arms (2)

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

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.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients aged 18-75 years old who intend to undergo magnetron capsule gastroscopy, regardless of gender

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shandong University: lead

Study Sites (1)

Department of Gastroenterology, Qilu Hospital, Shandong University

Jinan, Shandong, 250012, China

RECRUITING

Study Officials

• Li Yanqing

  Qilu Hospital of Shandong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Li Yanqing

CONTACT

053182169385; liyanqing@sdu.edu.cn

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice president of QiLu Hospital

Study Record Dates

• First Submitted: May 19, 2021
• First Posted: June 22, 2021
• Study Start: June 22, 2021
• Primary Completion: August 1, 2022
• Study Completion: March 1, 2023
• Last Updated: February 3, 2023

Record last verified: 2023-02

Locations

CN (1)