Analysis of Influencing Factors of Gastric Preparation Quality for MCCG

Capsule Endoscopy Clinical Trial

Official title:

Analysis of Influencing Factors of Gastric Preparation Quality for Magnetically Controlled Capsule Gastroscopy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04933643
• Other study ID #: 2020SDU-QILU-072
• Status: Recruiting
• Start date: June 22, 2021
• Est. completion date: March 2023

Study information

• Verified date: February 2023
• Source: Shandong University
• Contact: Li Yanqing
• Phone: 053182169385
• Email: liyanqing[@]sdu.edu.cn
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: March 2023
• Est. primary completion date: August 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Capsule Endoscopy

Locations

Country	Name	City	State
China	Department of Gastroenterology, Qilu Hospital, Shandong University	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Shandong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	The number of positive lesions	The positive lesions detected in this study refer to some focal lesions of the stomach, including polyps, ulcers, gastric varices, submucosal tumors and so on.The lesions were identified by physicians who had performed magnetic capsule gastroscopy in more than 400 cases.	24 months
Secondary	Number of participants with treatment-related adverse events as assessed by CTCAE v5.0	The safety of MCCG includes the acceptability or adverse events of MCCG preparation and examination, which is defined as symptoms or signs such as drinking water, examination and swallowing capsules, such as monitoring abdominal distension, nausea or vomiting.we count the number of participants with treatment-related adverse events as assessed by CTCAE v5.0	24 months