Clinical trial NCT05469152: Detachable String Magnetically Controlled Capsule Endoscopy for Follow-up of Patients With Esophageal Diseases
Official title: Accuracy of Detachable String Magnetically Controlled Capsule Endoscopy for Follow-up of Patients With Esophageal Diseases: A Multicenter Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Esophageal Diseases
Keywords: esophageal diseases
capsule endoscopy
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
Collaborators: name: Ruijin Hospital
name: Shanghai Zhongshan Hospital
name: XuHui District Central Hospital
name: Yangpu District Central Hospital Affiliated to Tongji University
name: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
name: Shanghai 6th People's Hospital
First posted: 2022-07-21
Enrollment: 310
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria:

1. Gender is not limited.
2. Patients aged between 18-75 years or older.
3. Both inpatients and outpatients.
4. Patients with previous esophageal diseases who are scheduled to undergo EGD for follow-up.
5. Able to provide informed consent.

Exclusion Criteria:

1. Patients aged less than 18 years.
2. Patients with active upper gastrointestinal bleeding.
3. Patients who have participated in or are participating in other clinical trials within three months.
4. Patients with cancer on active treatment with chemotherapy and/or radiation therapy.
5. Pregnancy or suspected pregnancy.
6. Suspected or known intestinal stenosis or other known risk factors for capsule retention.
7. Pacemaker or other implanted electromedical devices which could interfere with magnetic resonance.
8. Patients with dysphagia.

Primary outcomes:
measure: The diagnostic accuracy of the ds-MCE in identifying esophageal diseases in comparison to standardized EGD
timeFrame: 2 weeks
Secondary outcomes:
measure: Number of quadrants visualized at Z-line by ds-MCE
timeFrame: 2 weeks
measure: Scores of cleanliness of Z-line area
timeFrame: 2 weeks
measure: Number of ds-MCE associated adverse events
timeFrame: 2 weeks
measure: The patient satisfaction of the ds-MCE through questionnaires
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital
city: Shanghai
country: China
facility: Shanghai Changhai Hospital
city: Shanghai
country: China
facility: Shanghai General Hospital
city: Shanghai
country: China
facility: Shanghai Sixth People's Hospital
city: Shanghai
country: China
facility: Xuhui District Central Hospital
city: Shanghai
country: China
facility: Yangpu District Central Hospital
city: Shanghai
country: China
facility: Zhongshan Hospital
Study officials:
affiliation: Changhai Hospital
name: Zhuan Liao
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Chen WS, Zhu LH, Li DZ, Chen L, Wu YL, Wang W. String esophageal capsule endoscopy with real-time viewing improves visualization of the distal esophageal Z-line: a prospective, comparative study. Eur J Gastroenterol Hepatol. 2014 Mar;26(3):309-12. doi: 10.1097/MEG.0000000000000038.
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citation: Liao Z, Hou X, Lin-Hu EQ, Sheng JQ, Ge ZZ, Jiang B, Hou XH, Liu JY, Li Z, Huang QY, Zhao XJ, Li N, Gao YJ, Zhang Y, Zhou JQ, Wang XY, Liu J, Xie XP, Yang CM, Liu HL, Sun XT, Zou WB, Li ZS. Accuracy of Magnetically Controlled Capsule Endoscopy, Compared With Conventional Gastroscopy, in Detection of Gastric Diseases. Clin Gastroenterol Hepatol. 2016 Sep;14(9):1266-1273.e1. doi: 10.1016/j.cgh.2016.05.013. Epub 2016 May 20.
citation: Liao Z, Gao R, Xu C, Xu DF, Li ZS. Sleeve string capsule endoscopy for real-time viewing of the esophagus: a pilot study (with video). Gastrointest Endosc. 2009 Aug;70(2):201-9. doi: 10.1016/j.gie.2008.10.043. Epub 2009 Mar 14.
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