Clinical trial NCT03441945: Magnetic Steering Enhance Capsule Gastroscopy Gastric Emptying
Official title: New Method: Can Magnetic Steering Enhance Capsule Gastroscopy Gastric Emptying?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Capsule Endoscopy
Gastric Emptying
Keywords: Magnetic
Capsule Endoscopy
enhance
gastric emptying
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
First posted: 2018-02-22
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: PTT
timeFrame: 3 month
Secondary outcomes:
measure: DPDR
timeFrame: 3 month
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Changhai Hospital
Study officials:
References:
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citation: Jiang X, Qian YY, Liu X, Pan J, Zou WB, Zhou W, Luo YY, Chen YZ, Li ZS, Liao Z. Impact of magnetic steering on gastric transit time of a capsule endoscopy (with video). Gastrointest Endosc. 2018 Oct;88(4):746-754. doi: 10.1016/j.gie.2018.06.031. Epub 2018 Jul 11.