Detachable String MCE for Upper Gastrointestinal Tract and Small Bowel

Detachable String Magnetically Controlled Capsule Endoscopy for Complete Examination of Upper Gastrointestinal Tract and Small Bowel

This study aims to evaluate the feasibility and safety of DS-MCE with a novel way for complete examination in UGI tract and small bowel, compared with EGD.

Study Overview

• Status: Unknown
• Conditions: Capsule Endoscopy
• Intervention / Treatment: Device: DS-MCE

Detailed Description

Magnetically controlled capsule endoscopy (MCE) has been widely used in clinical practice for upper gastrointestinal (UGI) tract and Small Bowel. However, the complete visualization of UGI tract still present challenges due to rapid transit through esophagus and duodenum, although technical improvements of MCE are helpful.

Detachable String MCE (DS-MCE) can control the movement of MCE through the string and MCE can start next examination after string detachment, which was proved to be an effective and safe method for complete viewing of the esophagus and stomach. In order to improve the duodenum visualization, endoscopist separate MCE from the string after finishing UGI examination so that can inspect the esophagus, stomach and duodenum under the string and magnetic field control.

This is a prospective, single-centered, self-controlled pilot study. Subjects with or without digestive symptoms receiving UGI endoscopy will be enrolled to take DS-MCE and conventional esophagogastroduodenoscopy (EGD) within 48h successively.

• Study Type: Interventional
• Enrollment (Anticipated): 25
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bin Jiang; Phone Number: 15021569528 15021569528; Email: jarz1995@163.com

Study Locations

• China
  • Shanghai, China, 200433
    • Recruiting
    • Changhai Hospital
    • Sub-Investigator: Yang-Yang Qian
    • Sub-Investigator: Bin Jiang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Adult patients aged 18 to 80
2. With or without gastrointestinal complaints
3. Scheduled to undergo a capsule endoscopy for both stomach and small bowel
4. Signed the informed consents before joining this study

Exclusion Criteria:

1. Pacemakers or electromedical devices implanted which are incompatible with magnetic field;
2. Suspected or known gastrointestinal stenosis, obstruction or other known risk factors for capsule retention;
3. Scheduled magnetic resonance imaging examination before excretion of capsule;
4. Pregnancy or suspected pregnancy;
5. Any contraindications about EGD.
6. Other circumstances that doctors consider inappropriate for the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: DS-MCE examination; Subjects with or without digestive symptoms will be enrolled to take DS-MCE and conventional esophagogastroduodenoscopy (EGD) within 48h successively.

Device: DS-MCE; The subjects swallowed the MCE to investigate the esophagus repeatedly by pulling up or down the string. After completion of the esophageal examination, MCE reached the stomach and was lifted away from the posterior wall, rotated if necessary and advanced to the fundus and cardiac regions, and then to the gastric body, angulus, antrum and pylorus. After finishing the stomach examination, the capsule would enter the duodenum due to peristalsis when the pylorus opened. Then DS-MCE tried to inspect the duodenum repeatedly under the string and magnetic field control, including view of major papilla in the descending part of duodenum and retrograde view of pylorus in duodenal bulb with a "360-degree automatic scanning" mode. After completion of the duodenum examination, the capsule started to view the small bowel.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Success rate of UGI and small-bowel examination	The feasibility of DS-MCE examination with a novel way is evaluated by the technical success rate, a composite outcome including the successful separation of the string and MCE, repeat viewing of esophagus, stomach and duodenum, and complete small-bowel examination.	up to 2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic accuracy	The diagnostic accordance rate, sensitivity and specificity of lesions detected by DS-MCE compared with EGD.	up to 2 weeks
Safety of DS-MCE procedure: presence of any adverse events during DS-MCE procedure will be recorded	The presence of any adverse events during DS-MCE procedure will be recorded.	up to 2 weeks
Detection rate of Z-line, duodenal papilla and pyloric retrograde view	The detection means that at least one image of anatomical structure was obtained.	up to 2 weeks
Circumferential visualization of the Z-line and duodenal papilla	It 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.	up to 2 weeks
Cleansing level of Z-line and duodenal papilla area	The effect of bubbles/saliva on the appearance of the Z line or duodenal papilla area was both scored as follows: 0=no interference by bubbles/saliva;1=minor interference of bubbles/saliva; 2=major interference of bubbles/saliva.	up to 2 weeks
Visualization level of stomach	Visualization level of gastric primary anatomic landmarks: cardia, fundus, body, angulus, antrum and pylorus. (good, >75% of mucosa was observed; moderate, 50% to 75% was observed; poor, <50% of the gastric mucosa was observed)	up to 2 weeks
Examination time of esophagus, stomach, duodenum and small bowel	Record the time taken to finish examination in different digestive part.	up to 2 weeks
Pyloric transit time	Record the time from completion of the gastric examination to the capsule entering the duodenum.	up to 2 weeks
Discomfort scores associated with DS-MCE	Discomfort caused by the string, swallowing the DS-MCE, pulling the capsule up or down, and pulling the string out were on a scale from 0 to 3 (0=none;1=mild/minimal; 2=moderate; and 3=severe/very difficult) according to the Ramirez system. Overall discomfort was scored on a scale of 0 to 10 (0=no discomfort; 10=the overall discomfort of EGD) according to our previous system.	up to 2 weeks
Image quality scores	Assess Image quality grade ranged from 1 to 10 (1, the worst quality; 10, the quality of the best image captured by EGD).	up to 2 weeks
Detection rate of lesions	The detection rate of lesions in different digestive part (esophagus, stomach, duodenum, jejunoileum) found by MCE.	up to 2 weeks

Collaborators and Investigators

• Sponsor: Zhuan Liao
• Investigators: Study Director: Zhuan Liao, Changhai Hospital, Shanghai, China

Publications and helpful links

General Publications

• Chen YZ, Pan J, Luo YY, Jiang X, Zou WB, Qian YY, Zhou W, Liu X, Li ZS, Liao Z. Detachable string magnetically controlled capsule endoscopy for complete viewing of the esophagus and stomach. Endoscopy. 2019 Apr;51(4):360-364. doi: 10.1055/a-0856-6845. Epub 2019 Mar 1.

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2020
• Primary Completion (Anticipated): August 20, 2020
• Study Completion (Anticipated): September 20, 2020

Study Registration Dates

• First Submitted: March 27, 2020
• First Submitted That Met QC Criteria: March 30, 2020
• First Posted (Actual): April 1, 2020

Study Record Updates

• Last Update Posted (Actual): July 21, 2020
• Last Update Submitted That Met QC Criteria: July 20, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: DS-MCE; Z-line; Duodenal papilla; Completion rate
• Other Study ID Numbers: DS-MCE-UGI and SB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No