Magnetically Controlled Capsule Endoscopy in Visualization of the UGI and Small Intestine

Stomach Diseases Clinical Trial

Official title:

Feasibility of the Magnetically Controlled Capsule Endoscopy in One Time Visualization of the Upper Gastrointestinal Tract and Small Intestine

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05069233
• Other study ID #: MCE for UGI+SB
• Status: Recruiting
• Start date: September 27, 2021
• Est. completion date: December 30, 2021

Study information

• Verified date: September 2021
• Source: Changhai Hospital
• Contact: Zhuan Liao, Professor
• Phone: (81)02131161024
• Email: zhuanleo[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 593
• Est. completion date: December 30, 2021
• Est. primary completion date: December 28, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Intestinal Diseases
• Small Intestine Disease
• Stomach Diseases

Intervention

Other:
• UGI+SB
Patients who underwent combined upper digestive tract and small intestine examination under MCE.

Locations

Country	Name	City	State
China	Changhai Hospital	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Changhai Hospital	Chinese PLA General Hospital

Country where clinical trial is conducted

China, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success rate of UGI and small-bowel examination	The success rate of upper gastrointestinal tract and small-bowel examination under MCE is evaluated by the technical success rate, a composite outcome including the successful viewing of esophagus, stomach and duodenum, and complete small-bowel examination.	2 weeks
Secondary	Visualization of the esophagus	Visualization of the esophagus indicated by the number of images captured for Z-line and how many quadrants of the Z-line were observed. Circumferential visualization of the Z-line is defined by quadrants as follows: less than 2 quadrants (< 50%) observed; at least 2 quadrants (50%-75%) observed; at least 3 quadrants (>75%) observed; and entire structure (100%) observed.	2 weeks
Secondary	Visualization score of the gastric mucosa	Visualization score of the gastric mucosa To objectively evaluate the complete visualization of the gastric mucosa in the 6 anatomic landmarks (cardia, fundus, body, angulus, antrum, and pylorus), a 3-point grading scale was used: 1, poor (<70% of the mucosa was observed), 2, fair (70%-90% of the mucosa was observed), and 3, good (>90% of the mucosa was observed).	2 weeks
Secondary	Visualization of the small bowel	Visualization of the small bowel was determined by the percentage of time during which the small-bowel view was clear, defined as not obscured more than 50% of the screen view. The clear-viewing percentage of the total small-bowel transit time assessed by a 4-point scale :0, less than 25%; 1, 25% to 49%; 2, 50% to 75%; and 3, greater than 75%.	2 weeks
Secondary	Examination time of esophagus, stomach, duodenum and small bowel	Examination-related parameters included esophageal transit time (ETT), gastric examination time (GET), gastric transit time (GTT), pylorus transit time (PTT), small bowel transit time (SBTT). ETT is defined as the time between the first esophageal image and the first gastric image. GTT is defined as the time between the first gastric image and the first duodenal image. GET is defined as the time for examination of gastric primary anatomic landmarks twice. PTT is defined as the time between the first pyloric image and the first duodenal image. SBTT is defined as the time between the first duodenal image and the first cecal image.	1 month
Secondary	Detection rate of lesions	The detection rate of lesions in different digestive part (esophagus, stomach, duodenum, small intestine) found by MCE.	1 month
Secondary	Adverse events during MCE procedure	The presence of any adverse events during MCE procedure will be recorded.	1 month