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

NCT05469152 | Unknown

• 1 other identifier: DS-MCE-esophagus
• Study Type: interventional
• Target: 310
• Locations: 1 country
• Sites: 7

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.

Conditions

Esophageal Diseases

Keywords

esophageal diseases; capsule endoscopy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Number of quadrants visualized at Z-line by ds-MCE

  2 weeks

• Scores of cleanliness of Z-line area

  2 weeks

• Number of ds-MCE associated adverse events

  2 weeks

• The patient satisfaction of the ds-MCE through questionnaires

  2 weeks

Study Arms (1)

ds-MCE and EGD

EXPERIMENTAL

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

Interventions

ds-MCE and EGD DIAGNOSTIC_TEST

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.

ds-MCE and EGD

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Changhai Hospital: lead
• Ruijin Hospital: collaborator
• Shanghai Zhongshan Hospital: collaborator
• XuHui District Central Hospital: collaborator
• Yangpu District Central Hospital Affiliated to Tongji University: collaborator
• Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine: collaborator
• Shanghai 6th People's Hospital: collaborator

Study Sites (7)

Ruijin Hospital

Shanghai, China

RECRUITING

Shanghai Changhai Hospital

Shanghai, China

RECRUITING

Shanghai General Hospital

Shanghai, China

RECRUITING

Shanghai Sixth People's Hospital

Shanghai, China

RECRUITING

Xuhui District Central Hospital

Shanghai, China

RECRUITING

Yangpu District Central Hospital

Shanghai, China

RECRUITING

Zhongshan Hospital

Shanghai, China

RECRUITING

Related Publications (8)

• 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.

  PMID: 30822803 BACKGROUND

• 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.

  PMID: 18435461 BACKGROUND

• 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.

  PMID: 24429971 BACKGROUND

• 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.

  PMID: 11097497 BACKGROUND

• 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.

  PMID: 25590177 BACKGROUND

• 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.

  PMID: 27211503 BACKGROUND

• 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.

  PMID: 19286182 BACKGROUND

• 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.

  PMID: 25208463 BACKGROUND

MeSH Terms

Conditions

Esophageal Diseases

Interventions

Endoscopy, Digestive System

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Zhuan Liao

  Changhai Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhuan Liao

CONTACT

86-21-31161004; liaozhuan@smmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 11, 2022
• First Posted: July 21, 2022
• Study Start: July 15, 2019
• Primary Completion: September 15, 2022
• Study Completion: September 15, 2022
• Last Updated: July 21, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 3 years.
• Access Criteria: The website of the journal where the results published, and ClinicalTrials.gov web site.

Locations

CN (7)