Clinical trial NCT04329468: Detachable String MCE for Upper Gastrointestinal Tract and Small Bowel
Official title: Detachable String Magnetically Controlled Capsule Endoscopy for Complete Examination of Upper Gastrointestinal Tract and Small Bowel
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Capsule Endoscopy
Keywords: DS-MCE
Z-line
Duodenal papilla
Completion rate
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
First posted: 2020-04-01
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Success rate of UGI and small-bowel examination
timeFrame: up to 2 weeks
Secondary outcomes:
measure: Diagnostic accuracy
timeFrame: up to 2 weeks
measure: Safety of DS-MCE procedure: presence of any adverse events during DS-MCE procedure will be recorded
timeFrame: up to 2 weeks
measure: Detection rate of Z-line, duodenal papilla and pyloric retrograde view
timeFrame: up to 2 weeks
measure: Circumferential visualization of the Z-line and duodenal papilla
timeFrame: up to 2 weeks
measure: Cleansing level of Z-line and duodenal papilla area
timeFrame: up to 2 weeks
measure: Visualization level of stomach
timeFrame: up to 2 weeks
measure: Examination time of esophagus, stomach, duodenum and small bowel
timeFrame: up to 2 weeks
measure: Pyloric transit time
timeFrame: up to 2 weeks
measure: Discomfort scores associated with DS-MCE
timeFrame: up to 2 weeks
measure: Image quality scores
timeFrame: up to 2 weeks
measure: Detection rate of lesions
timeFrame: up to 2 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Changhai Hospital
Study officials:
affiliation: Changhai Hospital, Shanghai, China
name: Zhuan Liao
role: STUDY_DIRECTOR
References:
citation: 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.