MCE Direct Visualization of Drug Behavior in Upper-gastrointestinal Tract

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

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.

Study Overview

• Status: Completed
• Conditions: Capsule Endoscopy
• Intervention / Treatment: Device: Magnetically controlled capsule endoscopy

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).

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• China
  • Shanghai, China, 200433
    • Changhai Hospital

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

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Abdominal symptoms group; The investigators selected 10 subjects (male: female = 1: 1) from patients with a recent history of upper-gastrointestinal symptoms who met the indication of taking sucralfate suspension gel	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.
Healthy control group; The investigators selected another 10 subjects (male: female = 1: 1) from healthy volunteers.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with complications of MCE	Any complications associated with MCE.	2 weeks
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

Collaborators and Investigators

• Sponsor: Changhai Hospital
• Investigators: Study Chair: Zhuan Liao, Changhai Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 3, 2018
• Primary Completion (Actual): October 22, 2019
• Study Completion (Actual): February 14, 2020

Study Registration Dates

• First Submitted: March 27, 2020
• First Submitted That Met QC Criteria: March 27, 2020
• First Posted (Actual): March 31, 2020

Study Record Updates

• Last Update Posted (Actual): April 28, 2020
• Last Update Submitted That Met QC Criteria: April 26, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: Magnetically controlled capsule endoscopy; sucralfate gel; drug behavior; upper-gastrointestinal tract
• Other Study ID Numbers: MCE_sucralfate gel

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