Magnetic Steering Enhance Capsule Gastroscopy Gastric Emptying

Gastric Emptying Clinical Trial

Official title:

New Method: Can Magnetic Steering Enhance Capsule Gastroscopy Gastric Emptying?

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03441945
• Other study ID #: MS-enhance-MCCG-GE
• Status: Recruiting
• Phase: N/A
• First received: February 8, 2018
• Last updated: February 15, 2018
• Start date: May 1, 2017
• Est. completion date: February 28, 2018

Study information

• Verified date: February 2018
• Source: Changhai Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The research continuously enrolled 100 patients undergone MCCG between May to December 2017 as the intervention group with magnetic steering of capsule in the pylorus and duodenum, and randomly selected 100 patients before May 2017 from the database as the control group with passive movement of the capsule. The difference of the pyloric transit time (PTT) and duodenal papilla detection rate (DPDR) between the two groups were compared, and related factors were also investigated.

Description:

Background and Aims: Capsule endoscopy is a valuable tool in the diagnosis of small bowel disease. However, the incompletion of small bowel examination may reduce the diagnostic accuracy, which mainly caused by delayed capsule gastric emptying. Thus the aim of this study was to validate the effect of magnetic steering on enhancing gastric emptying and mucosal visualization within duodenum during magnetically controlled capsule gastroscopy (MCCG) examination.

Methods: As a historical prospective cohort study, the research continuously enrolled 100 patients undergone MCCG between May to December 2017 as the intervention group with magnetic steering of capsule in the pylorus and duodenum, and randomly selected 100 patients before May 2017 from the database as the control group with passive movement of the capsule. The difference of the pyloric transit time (PTT) and duodenal papilla detection rate (DPDR) between the two groups were compared, and related factors were also investigated.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: February 28, 2018
• Est. primary completion date: February 28, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. patients over 18 years of age undergone MCCG examination in Changhai Hospital

Exclusion Criteria:

1. pregnancy or suspected pregnancy;

2. suspected or known intestinal stenosis;

3. pacemaker, other implanted electro medical devices which could interfere with magnetic resonance; (4) undergone a known surgery which could possibly affect visualization of the duodenal papilla;

(5) other conditions which may lead to capsule retention.

Related Conditions & MeSH terms

• Capsule Endoscopy
• Gastric Emptying

Intervention

Other:
• magnetic steering
magnetic steering

Locations

Country	Name	City	State
China	Shanghai Changhai Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Zhuan Liao

Country where clinical trial is conducted

China, 

References & Publications (5)

Clarke JO, Giday SA, Magno P, Shin EJ, Buscaglia JM, Jagannath SB, Mullin GE. How good is capsule endoscopy for detection of periampullary lesions? Results of a tertiary-referral center. Gastrointest Endosc. 2008 Aug;68(2):267-72. doi: 10.1016/j.gie.2007.11.055. Epub 2008 Apr 18. — View Citation

Hale MF, Drew K, Sidhu R, McAlindon ME. Does magnetically assisted capsule endoscopy improve small bowel capsule endoscopy completion rate? A randomised controlled trial. Endosc Int Open. 2016 Feb;4(2):E215-21. doi: 10.1055/s-0035-1569846. — View Citation

Lee MM, Jacques A, Lam E, Kwok R, Lakzadeh P, Sandhar A, Segal B, Svarta S, Law J, Enns R. Factors associated with incomplete small bowel capsule endoscopy studies. World J Gastroenterol. 2010 Nov 14;16(42):5329-33. — 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	PTT	pyloric transit time	3 month
Secondary	DPDR	duodenal papilla detection rate	3 month