Clinical trial NCT05069233: Magnetically Controlled Capsule Endoscopy in Visualization of the UGI and Small Intestine
Official title: Feasibility of the Magnetically Controlled Capsule Endoscopy in One Time Visualization of the Upper Gastrointestinal Tract and Small Intestine
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stomach Diseases
Small Intestine Disease
Keywords: capsule endoscopy
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
Collaborators: name: Chinese PLA General Hospital
First posted: 2021-10-06
Enrollment: 593
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who underwent upper gastrointestinal and small intestinal mucosal examination under MCE at Shanghai Changhai Hospital and Chinese PLA General Hospital after January 2020.

Brief summary: In this study, we retrospectively analyzed the videos of combined upper digestive tract and small intestine examination under MCE, so as to clarify the feasibility and diagnostic efficacy of MCE in one-time examination of the upper gastrointestinal and small intestinal mucosa.

Detailed description: Magnetically controlled capsule endoscopy (MCE), with equally favorable diagnostic accuracy as conventional endoscopy, has become a painless noninvasive diagnostic modality in clinical practice. The more than 8 hours battery life of the MCE enables a further examination of the small bowel. In addition, it has been demonstrated that magnetic steering of capsule endoscopy improves the completion rate of small bowel examination by facilitating passage of the capsule through the pylorus, which further supported MCE as a practical modality for examination of both the stomach and small bowel. In this study, we retrospectively analyzed the videos of combined upper digestive tract and small intestine examination under MCE, so as to clarify the feasibility and diagnostic efficacy of MCE in one-time examination of the upper gastrointestinal and small intestinal mucosa.

Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 years old.
2. Those who underwent upper gastrointestinal and small intestinal mucosal examination under magnetically controlled capsule endoscopy at Shanghai Changhai Hospital and Chinese PLA General Hospital after January 2020.
3. Able to provide informed consent.

Exclusion Criteria:

1. Patients who fail to follow the prescribed procedures for magnetically controlled capsule endoscopy;
2. Patients who only undergo gastric examination under magnetically controlled capsule endoscopy;
3. Patients who only undergo small bowel examination under magnetic control capsule endoscopy;
4. The patient's basic information in the database is incomplete；
5. Patient fail to be followed up.

Primary outcomes:
measure: Success rate of UGI and small-bowel examination
timeFrame: 2 weeks
Secondary outcomes:
measure: Visualization of the esophagus
timeFrame: 2 weeks
measure: Visualization score of the gastric mucosa
timeFrame: 2 weeks
measure: Visualization of the small bowel
timeFrame: 2 weeks
measure: Examination time of esophagus, stomach, duodenum and small bowel
timeFrame: 1 month
measure: Detection rate of lesions
timeFrame: 1 month
measure: Adverse events during MCE procedure
timeFrame: 1 month
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Changhai Hospital
Study officials:
affiliation: Changhai Hospital,Shanghai,China
name: Zhuan Liao
role: PRINCIPAL_INVESTIGATOR
References:
citation: Liao Z, Hou X, Lin-Hu EQ, Sheng JQ, Ge ZZ, Jiang B, Hou XH, Liu JY, Li Z, Huang QY, Zhao XJ, Li N, Gao YJ, Zhang Y, Zhou JQ, Wang XY, Liu J, Xie XP, Yang CM, Liu HL, Sun XT, Zou WB, Li ZS. Accuracy of Magnetically Controlled Capsule Endoscopy, Compared With Conventional Gastroscopy, in Detection of Gastric Diseases. Clin Gastroenterol Hepatol. 2016 Sep;14(9):1266-1273.e1. doi: 10.1016/j.cgh.2016.05.013. Epub 2016 May 20.
citation: Jiang X, Qian YY, Liu X, Pan J, Zou WB, Zhou W, Luo YY, Chen YZ, Li ZS, Liao Z. Impact of magnetic steering on gastric transit time of a capsule endoscopy (with video). Gastrointest Endosc. 2018 Oct;88(4):746-754. doi: 10.1016/j.gie.2018.06.031. Epub 2018 Jul 11.
citation: Luo YY, Pan J, Chen YZ, Jiang X, Zou WB, Qian YY, Zhou W, Liu X, Li ZS, Liao Z. Magnetic Steering of Capsule Endoscopy Improves Small Bowel Capsule Endoscopy Completion Rate. Dig Dis Sci. 2019 Jul;64(7):1908-1915. doi: 10.1007/s10620-019-5479-z. Epub 2019 Feb 6.
citation: Chen X, Gao F, Zhang J. Screening for Gastric and Small Intestinal Mucosal Injury with Magnetically Controlled Capsule Endoscopy in Asymptomatic Patients Taking Enteric-Coated Aspirin. Gastroenterol Res Pract. 2018 Nov 15;2018:2524698. doi: 10.1155/2018/2524698. eCollection 2018.
citation: Liu YW, Wang YC, Zhu JH, Jiang X, Zhou W, Zhang J, Liao Z, Linghu EQ. Magnetically controlled capsule endoscopy in one-time gastro-small intestinal joint examination: a two-centre experience. BMC Gastroenterol. 2022 May 4;22(1):222. doi: 10.1186/s12876-022-02302-0.