Detachable String Magnetically Controlled Capsule Endoscopy for Follow-up of Patients With Esophageal Diseases

Study Overview
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Brief Summary
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The purpose of the study is to determine the accuracy of detachable string magnetically controlled capsule endoscopy(DS-MCE) as a follow-up method for patients with previous esophageal diseases.

Detailed Description
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Esophagogastroduodenoscopy (EGD) is recognized as the gold standard for detection and follow-up of esophageal diseases,allowing for direct mucosal visualization and therapeutic intervention. EGD is however an invasive procedure and there is potential for procedure-related complications, such as perforation and bleeding.Esophageal capsule endoscopy(ECE)provides a novel noninvasive approach to visualize the esophagus.The main drawback for the use of ECE is its unreliable transit time which often renders an inadequate visualization of the esophagus.Thus investigators have developed the detachable string magnetically controlled capsule endoscopy(DS-MCE) which can control the movement of the capsule through the string. The ds-MCE system consists of two parts: the magnetically controlled capsule endoscopy (MCE) system and a transparent latex sleeve with a hollow string. The magnetically controlled capsule endoscopy (MCE) system (Ankon Technologies, Shanghai, China) detects focal lesions in the stomach with comparable accuracy with conventional EGD. One end of the hollow string is a transparent thin latex sleeve that can be wrapped on the surface of the capsule, and the other end of the string is connected to the syringe. The capsule, which is partially enclosed within the sleeve, can be actively moved in the esophagus through the control of string. In this case, investigator can examine the entire esophageal mucosa several times under real time views. The capsule then could be detached from the string system through injecting air into the hollow string with the syringe after completing the examination of esophagus. The pilot study of ds-MCE confirmed it was a feasible, safe and well-tolerated method for completely viewing esophagus and stomach, without the need for sedation. Besides, the 8-10h battery life of the ds-MCE enables complete examination of the small bowel, which provides the possibility for screening pathological changes in the entire gastrointestinal tract. This study is a prospective, multi-centered, diagnostic accuracy study. The primary outcome is the diagnostic accuracy of ds-MCE in identifying esophageal diseases. Second outcomes include the visualization and cleanliness of Z-line, safety and patient satisfaction of DS-MCE.

Official Title
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Accuracy of Detachable String Magnetically Controlled Capsule Endoscopy for Follow-up of Patients With Esophageal Diseases: A Multicenter Study

Conditions
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Esophageal Diseases

Intervention / Treatment
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* Diagnostic Test: ds-MCE and EGD


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Gender is not limited. Patients aged between 18-75 years or older. Both inpatients and outpatients. Patients with previous esophageal diseases who are scheduled to undergo EGD for follow-up. Able to provide informed consent. Exclusion Criteria: Patients aged less than 18 years. Patients with active upper gastrointestinal bleeding. Patients who have participated in or are participating in other clinical trials within three months. Patients with cancer on active treatment with chemotherapy and/or radiation therapy. Pregnancy or suspected pregnancy. Suspected or known intestinal stenosis or other known risk factors for capsule retention. Pacemaker or other implanted electromedical devices which could interfere with magnetic resonance. Patients with dysphagia.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ds-MCE and EGD<br>All the enrolled participants will undergo the examination of detachable string magnetically controlled capsule endoscopy (ds-MCE) first, followed by EGD within 48 hours. | Diagnostic Test: ds-MCE and EGD<br>* Procedure of ds-MCE: The ds-MCE system mainly consists of two parts: the NaviCam magnetic capsule endoscopy guidance system and the detachable string part. The capsule, which is partially enclosed within the sleeve, can be actively moved in the esophagus through the control of string. Investigator can examine the entire esophagus several times under real time views. The capsule then could be detached from the string system through injecting air into the hollow string with the syringe after completing the examination of esophagus. Then, the examination of stomach under magnetic control and small bowel under the natural action of peristalsis follows. Procedure of EGD: The EGD will be performed using conventional upper gastrointestinal video endoscopy, according to the standard procedure at individual centers. EGD will be performed within 48 hours after ds-MCE procedure and usually during the same endoscopic session.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The diagnostic accuracy of the ds-MCE in identifying esophageal diseases in comparison to standardized EGD | To assess the diagnostic accuracy of the ds-MCE as a follow-up method for patients with previous esophageal diseases, using EGD as the gold standard. | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of quadrants visualized at Z-line by ds-MCE | To assess the visualization of Z-line. Circumferential visualization of the Z line by ds-MCE was defined by quadrants as follows: Z line not observed at all; less than 2 quadrants (< 50 %) of the Z line observed; between 2 quadrants and 3 quadrants (50 % - 75%) observed; more than 3 quadrants (> 75%) observed; and entire Z line (100 %) observed. | 2 weeks | 
| Scores of cleanliness of Z-line area | The effect of bubbles/saliva on the appearance of the Z line area was scored as follows: 0 = no interference by bubbles/saliva on the Z line area; 1 = minor interference of bubbles/saliva on the Z line area; 2 = major interference of bubbles/saliva on the Z line area. | 2 weeks | 
| Number of ds-MCE associated adverse events | To assess the safety of ds-MCE. | 2 weeks | 
| The patient satisfaction of the ds-MCE through questionnaires | To assess the patient satisfaction of the ds-MCE compared to standard EGD. | 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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esophageal diseases, capsule endoscopy