Detachable String Magnetically Controlled Capsule Endoscopy for Follow-up of Patients With Esophageal Diseases
NCT ID: NCT05469152
Last Updated: 2022-07-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
310 participants
INTERVENTIONAL
2019-07-15
2022-09-15
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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ds-MCE and EGD
All the enrolled participants will undergo the examination of detachable string magnetically controlled capsule endoscopy (ds-MCE) first, followed by EGD within 48 hours.
ds-MCE and EGD
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.
Interventions
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ds-MCE and EGD
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.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
75 Years
ALL
No
Sponsors
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Ruijin Hospital
OTHER
Shanghai Zhongshan Hospital
OTHER
XuHui District Central Hospital
UNKNOWN
Yangpu District Central Hospital Affiliated to Tongji University
OTHER
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
OTHER
Shanghai 6th People's Hospital
OTHER
Changhai Hospital
OTHER
Responsible Party
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Zhuan Liao
Professor
Principal Investigators
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Zhuan Liao
Role: PRINCIPAL_INVESTIGATOR
Changhai Hospital
Locations
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Ruijin Hospital
Shanghai, , China
Shanghai Changhai Hospital
Shanghai, , China
Shanghai General Hospital
Shanghai, , China
Shanghai Sixth People's Hospital
Shanghai, , China
Xuhui District Central Hospital
Shanghai, , China
Yangpu District Central Hospital
Shanghai, , China
Zhongshan Hospital
Shanghai, , China
Countries
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Central Contacts
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Facility Contacts
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Zhuan Liao
Role: primary
Jinshui Zhu
Role: primary
Yunshi Zhong
Role: primary
Pinghong Zhou
Role: primary
References
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Chen YZ, Pan J, Luo YY, Jiang X, Zou WB, Qian YY, Zhou W, Liu X, Li ZS, Liao Z. Detachable string magnetically controlled capsule endoscopy for complete viewing of the esophagus and stomach. Endoscopy. 2019 Apr;51(4):360-364. doi: 10.1055/a-0856-6845. Epub 2019 Mar 1.
de Franchis R, Eisen GM, Laine L, Fernandez-Urien I, Herrerias JM, Brown RD, Fisher L, Vargas HE, Vargo J, Thompson J, Eliakim R. Esophageal capsule endoscopy for screening and surveillance of esophageal varices in patients with portal hypertension. Hepatology. 2008 May;47(5):1595-603. doi: 10.1002/hep.22227.
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.
de Franchis R. Updating consensus in portal hypertension: report of the Baveno III Consensus Workshop on definitions, methodology and therapeutic strategies in portal hypertension. J Hepatol. 2000 Nov;33(5):846-52. doi: 10.1016/s0168-8278(00)80320-7. No abstract available.
Zou WB, Hou XH, Xin L, Liu J, Bo LM, Yu GY, Liao Z, Li ZS. Magnetic-controlled capsule endoscopy vs. gastroscopy for gastric diseases: a two-center self-controlled comparative trial. Endoscopy. 2015 Jun;47(6):525-8. doi: 10.1055/s-0034-1391123. Epub 2015 Jan 15.
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.
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.
Hosoe N, Naganuma M, Ogata H. Current status of capsule endoscopy through a whole digestive tract. Dig Endosc. 2015 Jan;27(2):205-15. doi: 10.1111/den.12380. Epub 2014 Oct 20.
Other Identifiers
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DS-MCE-esophagus
Identifier Type: -
Identifier Source: org_study_id
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