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

Esophageal Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05469152
• Other study ID #: DS-MCE-esophagus
• Status: Recruiting
• Phase: N/A
• Start date: July 15, 2019
• Est. completion date: September 15, 2022

Study information

• Verified date: July 2022
• Source: Changhai Hospital
• Contact: Zhuan Liao
• Phone: 86-21-31161004
• Email: liaozhuan[@]smmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 310
• Est. completion date: September 15, 2022
• Est. primary completion date: September 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Esophageal Diseases

Intervention

Diagnostic Test:
• 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.

Locations

Country	Name	City	State
China	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

Sponsors (7)

Lead Sponsor	Collaborator
Changhai Hospital	Ruijin Hospital, Shanghai 6th People's Hospital, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai Zhongshan Hospital, XuHui District Central Hospital, Yangpu District Central Hospital Affiliated to Tongji University

Country where clinical trial is conducted

China, 

References & Publications (8)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View 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. — View 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Number of ds-MCE associated adverse events	To assess the safety of ds-MCE.	2 weeks
Secondary	The patient satisfaction of the ds-MCE through questionnaires	To assess the patient satisfaction of the ds-MCE compared to standard EGD.	2 weeks