Magnetic Steering Enhance Capsule Gastroscopy Gastric Emptying
New Method: Can Magnetic Steering Enhance Capsule Gastroscopy Gastric Emptying?
1 other identifier
interventional
200
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2017
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2017
CompletedFirst Submitted
Initial submission to the registry
February 8, 2018
CompletedFirst Posted
Study publicly available on registry
February 22, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2018
CompletedFebruary 22, 2018
February 1, 2018
10 months
February 8, 2018
February 15, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
PTT
pyloric transit time
3 month
Secondary Outcomes (1)
DPDR
3 month
Study Arms (2)
control
NO INTERVENTIONThe patients swallowed the capsule with water in the lying position.After finishing the stomach examination, the operation of the capsule is adjusted to "small bowel mode" without magnetic control. Capsule entered the duodenum under physiological peristalsis. The position of the capsule was established using a real-time viewer. If the capsule failed to enter the duodenum after one hour, domperidone (10 mg) was orally administered.
magnetic steering
EXPERIMENTALAfter finishing the stomach examination as the control protocol, the capsule was lifted with the magnetic control, then rotating the capsule until the camera end oriented toward the pylorus . Next, the endoscopist could drag the capsule close to the pylorus with the guidance magnet robot, waiting for the open of pylorus. Once the pylorus opened, the capsule could enter the duodenum with gastric peristalsis. After reaching the duodenal bulb, capsule was held to the maximum position of "Z", then the capsule would scan the duodenal bulb automatically with the mode "360° automatic scanning".
Interventions
Eligibility Criteria
You may qualify if:
- \. patients over 18 years of age undergone MCCG examination in Changhai Hospital
You may not qualify if:
- pregnancy or suspected pregnancy;
- suspected or known intestinal stenosis;
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Zhuan Liaolead
Study Sites (1)
Shanghai Changhai Hospital
Shanghai, China
Related Publications (6)
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: 25590177BACKGROUNDLiao 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: 27211503BACKGROUNDLee 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. doi: 10.3748/wjg.v16.i42.5329.
PMID: 21072896BACKGROUNDClarke 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.
PMID: 18378233BACKGROUNDHale 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.
PMID: 26878053RESULTJiang 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.
PMID: 30005825DERIVED
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- professor
Study Record Dates
First Submitted
February 8, 2018
First Posted
February 22, 2018
Study Start
May 1, 2017
Primary Completion
February 28, 2018
Study Completion
February 28, 2018
Last Updated
February 22, 2018
Record last verified: 2018-02