Gastric Emptying Clinical Trial
Official title:
New Method: Can Magnetic Steering Enhance Capsule Gastroscopy Gastric Emptying?
Verified date | February 2018 |
Source | Changhai Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
China | Shanghai Changhai Hospital | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Zhuan Liao |
China,
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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
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | PTT | pyloric transit time | 3 month | |
Secondary | DPDR | duodenal papilla detection rate | 3 month |
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