Capsule Endoscopy Clinical Trial
Official title:
Magnetic Steering of Capsule Endoscopy Improves Small Bowel Capsule Endoscopy Completion Rate
NCT number | NCT03482661 |
Other study ID # | MCE-CECR |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | June 1, 2017 |
Est. completion date | November 30, 2017 |
Verified date | May 2018 |
Source | Changhai Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Patients referred for magnetically controlled capsule endoscopy (MCE) in the participating center from June 2017 to November 2017 were prospectively enrolled. Magnetic steering of MCE was performed after standard gastric examination. Capsule endoscopy completion rate (CECR), gastric transit time (GTT), pyloric transit time (PTT) and rapid gastric transit rate (GTT ≤ 30 min) were compared with the historical control group enrolled from January 2017 to May 2017.
Status | Completed |
Enrollment | 227 |
Est. completion date | November 30, 2017 |
Est. primary completion date | November 30, 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Adult patients aged over 18 - With gastrointestinal complaints - Scheduled to undergo a capsule endoscopy for both stomach and small bowel Exclusion Criteria: - No surgical condition or refusing abdominal surgery to take out the capsule in case of capsule retention - Implanted pacemaker, except the pacemaker is compatible with MRI - Other implanted electromedical devices or magnetic metal foreign bodies - Pregnancy or suspected pregnancy |
Country | Name | City | State |
---|---|---|---|
China | Shanghai Changhai Hospital | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Zhuan Liao |
China,
Albrecht H, Vetter M, Dauth W, Zoicas F, Neurath MF, Hagel AF. The impact of hospitalization on the performance of capsule endoscopy (CE). Dig Liver Dis. 2017 Jun;49(6):647-650. doi: 10.1016/j.dld.2017.02.010. Epub 2017 Feb 20. — View Citation
Cheung DY, Kim JS, Shim KN, Choi MG; Korean Gut Image Study Group. The Usefulness of Capsule Endoscopy for Small Bowel Tumors. Clin Endosc. 2016 Jan;49(1):21-5. doi: 10.5946/ce.2016.49.1.21. Epub 2016 Jan 28. Review. — View Citation
Kopylov U, Yung DE, Engel T, Vijayan S, Har-Noy O, Katz L, Oliva S, Avni T, Battat R, Eliakim R, Ben-Horin S, Koulaouzidis A. Diagnostic yield of capsule endoscopy versus magnetic resonance enterography and small bowel contrast ultrasound in the evaluation of small bowel Crohn's disease: Systematic review and meta-analysis. Dig Liver Dis. 2017 Aug;49(8):854-863. doi: 10.1016/j.dld.2017.04.013. Epub 2017 Apr 27. Review. — View Citation
Koulaouzidis A, Giannakou A, Yung DE, Dabos KJ, Plevris JN. Do prokinetics influence the completion rate in small-bowel capsule endoscopy? A systematic review and meta-analysis. Curr Med Res Opin. 2013 Sep;29(9):1171-85. doi: 10.1185/03007995.2013.818532. Epub 2013 Jul 11. Review. — View Citation
Liao Z, Gao R, Xu C, Li ZS. Indications and detection, completion, and retention rates of small-bowel capsule endoscopy: a systematic review. Gastrointest Endosc. 2010 Feb;71(2):280-6. doi: 10.1016/j.gie.2009.09.031. Review. — 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
Ou G, Svarta S, Chan C, Galorport C, Qian H, Enns R. The effect of chewing gum on small-bowel transit time in capsule endoscopy: a prospective, randomized trial. Gastrointest Endosc. 2014 Apr;79(4):630-6. doi: 10.1016/j.gie.2013.08.038. Epub 2013 Oct 7. — View Citation
Pennazio M, Spada C, Eliakim R, Keuchel M, May A, Mulder CJ, Rondonotti E, Adler SN, Albert J, Baltes P, Barbaro F, Cellier C, Charton JP, Delvaux M, Despott EJ, Domagk D, Klein A, McAlindon M, Rosa B, Rowse G, Sanders DS, Saurin JC, Sidhu R, Dumonceau JM, Hassan C, Gralnek IM. Small-bowel capsule endoscopy and device-assisted enteroscopy for diagnosis and treatment of small-bowel disorders: European Society of Gastrointestinal Endoscopy (ESGE) Clinical Guideline. Endoscopy. 2015 Apr;47(4):352-76. doi: 10.1055/s-0034-1391855. Epub 2015 Mar 31. — View Citation
Prichard D, Ou G, Galorport C, Enns R. Sham Feeding with Bacon Does Not Alter Transit Time or Complete Examination Rate During Small Bowel Capsule Endoscopy. Dig Dis Sci. 2018 Feb;63(2):422-428. doi: 10.1007/s10620-017-4901-7. Epub 2018 Jan 4. — View Citation
Tziatzios G, Gkolfakis P, Dimitriadis GD, Triantafyllou K. Long-term effects of video capsule endoscopy in the management of obscure gastrointestinal bleeding. Ann Transl Med. 2017 May;5(9):196. doi: 10.21037/atm.2017.03.80. Review. — View Citation
Zhu SG, Qian YY, Tang XY, Zhu QQ, Zhou W, Du H, An W, Su XJ, Zhao AJ, Ching HL, McAlindon ME, Li ZS, Liao Z. Gastric preparation for magnetically controlled capsule endoscopy: A prospective, randomized single-blinded controlled trial. Dig Liver Dis. 2018 Jan;50(1):42-47. doi: 10.1016/j.dld.2017.09.129. Epub 2017 Oct 6. — 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
* Note: There are 12 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | CECR | Capsule endoscopy completion rate | Two weeks | |
Secondary | Diagnostic cases by MCE | Esophageal, gastric, small bowel and colon diseases diagnosed by MCE | Two weeks | |
Secondary | Transit time | Esophageal/gastric/pyloric/small bowel/total transit time | Two weeks | |
Secondary | Rapid gastric transit rate | Rate of patients with a gastric transit time of = 30 min | Two weeks |
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