Clinical trial NCT04327869: MCE Direct Visualization of Drug Behavior in Upper-gastrointestinal Tract
Official title: Feasibility of Using Magnetically-controlled Capsule Endoscopy for Direct Visualization of Drug Behavior in Upper-gastrointestinal Tract
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Capsule Endoscopy
Keywords: Magnetically controlled capsule endoscopy
sucralfate gel
drug behavior
upper-gastrointestinal tract
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
First posted: 2020-03-31
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Volunteers who agreed to participate in the feasibility examination of MCE direct visualization of sucralfate gel behavior in fasted stomach.

Brief summary: The investigators aim to explore the feasibility of MCE in direct, real-time visualization of drug behavior in upper-gastrointestinal tract, which presented by the adhesion, distribution, and dissipation characteristics of dyed sucralfate gel.

Detailed description: This pilot study was a prospective, single-centered, nonrandomized study. The investigators selected 10 subjects from patients with a recent history of upper-gastrointestinal symptoms who met the indication of taking sucralfate suspension gel, and another 10 subjects from healthy volunteers.

Procedures were performed by the NaviCam magnetic capsule guidance system. To enhance discrimination, the sucralfate gel dyed with 0.3 ml methylene blue. The subjects swallowed the capsule with water in the left lateral position. When capsule enter stomach cavity, subject was asked to sit up and ingested 4 g aerogenic powder with 5 ml water to distend the stomach, and performed gastric baseline examinations to identify the lesions. After baseline examination, subjects ingested dyed sucralfate gel and performed the first-time examination. The examination was repeated at 30 min intervals, until dyed sucralfate gel disappeared completely. When study completed, the capsule was detached from string and continued into the small bowel for further examination.

The endoscopists recorded the adhesion and dissipation times of dyed sucralfate gel, calculated the efficient time, and selected the images of six primary anatomic landmarks from each examination to measure the distribution area (%) . Any complication or discomfort during the procedure was evaluated. The discomfort was scored on a scale from 0 to 3 (0 = no; 1 = mild/minimal; 2 = moderate; 3 = sever/very difficult).

Eligibility criteria: Inclusion Criteria:

* With or without gastrointestinal complaints
* Scheduled to undergo a capsule endoscopy for both stomach and small bowel
* Signed the informed consents before joining this study

Exclusion Criteria:

* Suspected or known gastrointestinal stenosis
* Obstruction or other known risk factors for capsule retention
* Pregnancy or suspected pregnancy
* Pacemakers or electromedical devices implanted
* Any other contraindications determined by endoscopists

Primary outcomes:
measure: Sucralfate gel adhesion behavior in the fasted gastric cavity
timeFrame: 180 minutes
measure: Sucralfate gel distribution behavior in the fasted gastric cavity
timeFrame: 0, 30, 60, 90, 150, 180 min after dyed sucralfate gel enter the stomach
measure: Sucralfate gel dissipation behavior in the fasted gastric cavity
timeFrame: 180 minutes
Secondary outcomes:
measure: Number of Participants with complications of MCE
timeFrame: 2 weeks
measure: Discomfort scores of participants during the procedure
timeFrame: during the procedure
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Changhai Hospital
Study officials:
affiliation: Changhai Hospital
name: Zhuan Liao
role: STUDY_CHAIR
References:
citation: Wang YC, Pan J, Jiang B, Qian YY, Qiu XO, Yuan YZ, Li ZS, Liao Z. Direct visualization of drug behaviors in the upper GI tract via magnetically controlled capsule endoscopy. VideoGIE. 2021 May 28;6(7):333-338. doi: 10.1016/j.vgie.2021.04.004. eCollection 2021 Jul.