MCE Direct Visualization of Drug Behavior in Upper-gastrointestinal Tract

NCT ID: NCT04327869

Last Updated: 2020-04-28

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-11-03
• Study Completion Date: 2020-02-14

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).

Conditions

Capsule Endoscopy

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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

Magnetically controlled capsule endoscopy

Intervention Type: 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.

Healthy control group

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

Magnetically controlled capsule endoscopy

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Changhai Hospital

OTHER

Sponsor Role: lead

Responsible Party

Zhuan Liao

M.D., Associate Professor, Associate Chief Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zhuan Liao

Role: STUDY_CHAIR

Changhai Hospital

Locations

Changhai Hospital

Shanghai, , China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 34278100 (View on PubMed)

Other Identifiers

MCE_sucralfate gel

Identifier Type: -

Identifier Source: org_study_id