MCE Direct Visualization of Drug Behavior in Upper-gastrointestinal Tract

NCT04327869 | Completed

• 1 other identifier: MCE_sucralfate gel
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Capsule Endoscopy

Keywords

Magnetically controlled capsule endoscopy; sucralfate gel; drug behavior; upper-gastrointestinal tract

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Number of Participants with complications of MCE

  2 weeks

• Discomfort scores of participants during the procedure

  during the procedure

Study Arms (2)

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

Healthy control group

The investigators selected another 10 subjects (male: female = 1: 1) from healthy volunteers.

Device: Magnetically controlled capsule endoscopy

Interventions

Magnetically controlled capsule endoscopy DEVICE

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.

Abdominal symptoms group; Healthy control group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Changhai Hospital: lead

Study Sites (1)

Changhai Hospital

Shanghai, 200433, China

Location

Related Publications (1)

• 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.

  PMID: 34278100 DERIVED

MeSH Terms

Interventions

Endoscopy

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Zhuan Liao

  Changhai Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., Associate Professor, Associate Chief Physician

Study Record Dates

• First Submitted: March 27, 2020
• First Posted: March 31, 2020
• Study Start: November 3, 2018
• Primary Completion: October 22, 2019
• Study Completion: February 14, 2020
• Last Updated: April 28, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)