A randomized controlled trial comparing efficacy of early video capsule endoscopy with standard of care in the approach to nonhematemesis GI bleeding (with videos).
Aged
Aged, 80 and over
Anemia
/ etiology
Capsule Endoscopy
/ methods
Colonoscopy
/ methods
Early Diagnosis
Endoscopy, Digestive System
/ methods
Female
Gastrointestinal Hemorrhage
/ diagnosis
Humans
Kaplan-Meier Estimate
Logistic Models
Male
Melena
Middle Aged
Multivariate Analysis
Proportional Hazards Models
Standard of Care
Time Factors
Journal
Gastrointestinal endoscopy
ISSN: 1097-6779
Titre abrégé: Gastrointest Endosc
Pays: United States
ID NLM: 0010505
Informations de publication
Date de publication:
01 2019
01 2019
Historique:
received:
05
04
2018
accepted:
09
06
2018
pubmed:
24
6
2018
medline:
12
4
2019
entrez:
24
6
2018
Statut:
ppublish
Résumé
Patients presenting with nonhematemesis GI bleeding (NHGIB) represent a diagnostic challenge for physicians. We performed a randomized controlled trial to assess the benefits of deployment of a video capsule soon after admission in the management of patients presenting with melena, hematochezia, or severe anemia compared with standard of care management. Patients admitted with NHGIB were randomized and placed into 1 of 2 study groups. In the experimental group, patients ingested a video capsule soon after admission to the hospital. These patients had further endoscopic workup based on the findings from the capsule. Patients in the control group underwent endoscopic evaluation (ie, upper endoscopy, capsule endoscopy, and/or colonoscopy) to identify the source of bleeding as directed by the attending gastroenterologist's interpretation of their clinical presentation. The primary endpoint for this study was the rate of localization of bleeding during hospitalization. Eighty-seven patients were included in this study: 45 randomized to the standard of care arm and 42 to the early capsule arm. A bleeding source was localized in 64.3% of the patients in the early capsule arm and in 31.1% of the patients in the standard of care arm (P < .01). The likelihood of endoscopic localization of bleeding over time was greater for patients receiving early capsule endoscopy compared with those in the standard of care arm (adjusted hazard ratio, 2.77; 95% confidence interval, 1.36-5.64). For patients admitted to the hospital for NHGIB, early capsule endoscopy is a safe and effective alternative for the detection of the source of bleeding. (Clinical trial registration number: NCT02442830.).
Sections du résumé
BACKGROUND AND AIMS
Patients presenting with nonhematemesis GI bleeding (NHGIB) represent a diagnostic challenge for physicians. We performed a randomized controlled trial to assess the benefits of deployment of a video capsule soon after admission in the management of patients presenting with melena, hematochezia, or severe anemia compared with standard of care management.
METHODS
Patients admitted with NHGIB were randomized and placed into 1 of 2 study groups. In the experimental group, patients ingested a video capsule soon after admission to the hospital. These patients had further endoscopic workup based on the findings from the capsule. Patients in the control group underwent endoscopic evaluation (ie, upper endoscopy, capsule endoscopy, and/or colonoscopy) to identify the source of bleeding as directed by the attending gastroenterologist's interpretation of their clinical presentation. The primary endpoint for this study was the rate of localization of bleeding during hospitalization.
RESULTS
Eighty-seven patients were included in this study: 45 randomized to the standard of care arm and 42 to the early capsule arm. A bleeding source was localized in 64.3% of the patients in the early capsule arm and in 31.1% of the patients in the standard of care arm (P < .01). The likelihood of endoscopic localization of bleeding over time was greater for patients receiving early capsule endoscopy compared with those in the standard of care arm (adjusted hazard ratio, 2.77; 95% confidence interval, 1.36-5.64).
CONCLUSIONS
For patients admitted to the hospital for NHGIB, early capsule endoscopy is a safe and effective alternative for the detection of the source of bleeding. (Clinical trial registration number: NCT02442830.).
Identifiants
pubmed: 29935143
pii: S0016-5107(18)32778-0
doi: 10.1016/j.gie.2018.06.016
pmc: PMC6501558
mid: NIHMS1017791
pii:
doi:
Banques de données
ClinicalTrials.gov
['NCT02442830']
Types de publication
Comparative Study
Journal Article
Randomized Controlled Trial
Video-Audio Media
Langues
eng
Sous-ensembles de citation
IM
Pagination
33-43.e4Subventions
Organisme : NIDDK NIH HHS
ID : T32 DK007038
Pays : United States
Commentaires et corrections
Type : CommentIn
Type : CommentIn
Type : CommentIn
Type : CommentIn
Type : CommentIn
Informations de copyright
Copyright © 2019 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.
Références
N Engl J Med. 2000 Jan 13;342(2):78-82
pubmed: 10631275
Nature. 2000 May 25;405(6785):417
pubmed: 10839527
Lancet. 2000 Oct 14;356(9238):1318-21
pubmed: 11073021
Value Health. 2008 Jan-Feb;11(1):1-3
pubmed: 18237354
Best Pract Res Clin Gastroenterol. 2008;22(2):313-28
pubmed: 18346686
Gastrointest Endosc. 2009 Apr;69(4):786-99
pubmed: 19152905
Ann Intern Med. 2010 Jan 19;152(2):101-13
pubmed: 20083829
J Gastroenterol Hepatol. 2011 Aug;26(8):1270-4
pubmed: 21443670
Am J Gastroenterol. 2012 Mar;107(3):345-60; quiz 361
pubmed: 22310222
Gastrointest Endosc. 2012 Jun;75(6):1132-8
pubmed: 22624808
Dig Liver Dis. 2013 Mar;45(3):179-85
pubmed: 22921043
World J Gastroenterol. 2012 Nov 21;18(43):6235-9
pubmed: 23180943
Gastrointest Endosc. 2013 May;77(5):761-6
pubmed: 23375526
Cochrane Database Syst Rev. 2014 Oct 13;(10):CD005584
pubmed: 25308912
Gastrointest Endosc. 2015 Apr;81(4):889-95
pubmed: 25432532
Gastroenterol Clin North Am. 2014 Dec;43(4):643-63
pubmed: 25440917
Gastrointest Endosc. 2015 Apr;81(4):896-7
pubmed: 25805463
Am J Gastroenterol. 2015 Sep;110(9):1265-87; quiz 1288
pubmed: 26303132
Endoscopy. 2015 Oct;47(10):a1-46
pubmed: 26417980
Clin Gastroenterol Hepatol. 2016 Apr;14(4):558-64
pubmed: 26492844
Gastrointest Endosc. 2016 Dec;84(6):907-913
pubmed: 27156655
Dig Dis Sci. 2016 Sep;61(9):2732-40
pubmed: 27286877
J Clin Gastroenterol. 2017 Sep;51(8):720-727
pubmed: 27557115
Gastrointest Endosc. 2017 May;85(5):945-952.e1
pubmed: 27693643
BMJ. 2017 Jan 4;356:i6432
pubmed: 28053181
Lancet. 1974 Aug 17;2(7877):394-7
pubmed: 4136718
Am J Gastroenterol. 1995 Feb;90(2):206-10
pubmed: 7847286
Am J Gastroenterol. 1997 Mar;92(3):419-24
pubmed: 9068461