MCE Direct Visualization of Drug Behavior in Upper-gastrointestinal Tract

Capsule Endoscopy Clinical Trial

Official title:

Feasibility of Using Magnetically-controlled Capsule Endoscopy for Direct Visualization of Drug Behavior in Upper-gastrointestinal Tract

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04327869
• Other study ID #: MCE_sucralfate gel
• Status: Completed
• Start date: November 3, 2018
• Est. completion date: February 14, 2020

Study information

• Verified date: April 2020
• Source: Changhai Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 14, 2020
• Est. primary completion date: October 22, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Capsule Endoscopy

Intervention

Device:
• Magnetically controlled capsule endoscopy
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.

Locations

Country	Name	City	State
China	Changhai Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Changhai Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sucralfate gel adhesion behavior in the fasted gastric cavity	The adhesion time was recorded from the sucralfate gel entered the stomach to all sucralfate adhered to the gastric wall.	180 minutes
Primary	Sucralfate gel distribution behavior in the fasted gastric cavity	The distribution area of sucralfate gel was measured by selecting images of six primary anatomic landmarks (cardia, fundus, body, angulus, antrum, and pylorus) at different times, the images were imported into MATLAB software to calculate the area of sucrafate gel. The dynamic changes of distribution area of sucralfate gel over the time were analyzed and performed with GraphPad Prism.	0, 30, 60, 90, 150, 180 min after dyed sucralfate gel enter the stomach
Primary	Sucralfate gel dissipation behavior in the fasted gastric cavity	The dissipation time was evaluated by calculating the times between sucralfate gel entered the stomach and adhered sucralfate disappeared completely.	180 minutes
Secondary	Number of Participants with complications of MCE	Any complications associated with MCE.	2 weeks
Secondary	Discomfort scores of participants during the procedure	The discomfort associated with the procedure included swallow difficulty, nausea caused by string, pulling capsule up and down, abdominal distension or pain caused by ingesting aerogenic powder, discomfort during MCE examination, and pulling the string out. The discomfort was scored on a scale from 0 to 3 (0 = no; 1 = mild/minimal; 2 = moderate; 3 = sever/very difficult).	during the procedure