title: A double-blind, randomized, sham-controlled trial of the effect of a radiation-attenuating drape on radiation exposure to endoscopy staff during ERCP.
abstract: OBJECTIVE
  Endoscopic retrograde cholangiopancreatography (ERCP) is associated with radiation exposure to the endoscopist and staff that may be significant in high-volume centers. We investigated whether a radiation-attenuating drape over the fluoroscopy image intensifier reduces radiation exposure during ERCP.
  
  
  METHODS
  We performed a prospective, randomized, double-blind trial of 100 therapeutic ERCPs at a tertiary-care university center. Procedures were randomly assigned to groups receiving lead-free radiation-attenuating drapes (n=50) or identical sham drapes (n=50). The drapes were suspended around the fluoroscopy image intensifier during ERCP. The primary end point was the effective dose of radiation measured at the endoscopist's eye and neck, and at the assisting nurse's neck. The cumulative annual radiation exposure was also estimated.
  
  
  RESULTS
  Fluoroscopy time, absorbed radiation dose, and dose area product were similar in the study groups. Mean effective dose for sham vs. radiation-attenuating drape was 0.21±0.27 vs. 0.02±0.02 mSv at the endoscopist's eye, 0.35±0.44 vs. 0.03±0.03 mSv at the endoscopist's neck, and 0.27±0.34 vs. 0.02±0.02 mSv at the nurse's neck (P<0.0001 for all comparisons). The relative risk reduction in radiation was 90%, 91%, and 93% at the three sites. At a high-volume center in which an endoscopist performs 500 therapeutic ERCPs per year, the estimated cumulative annual effective dose at the endoscopist's eye level is 126 mSv with conventional protection and 12 mSv with a radiation-attenuating drape, with the recommended limit being 20 mSv.
  
  
  CONCLUSIONS
  The addition of a radiation-attenuating drape around the image intensifier during ERCP significantly decreases radiation exposure to endoscopists and staff by ∼90%.
authors.affiliation: Section of Digestive Disease, Yale School of Medicine, New Haven, Connecticut, USA.
authors.forename: Thiruvengadam
authors.initials: T
authors.lastname: Muniraj
authors.affiliation: Section of Digestive Disease, Yale School of Medicine, New Haven, Connecticut, USA.
authors.forename: Harry R
authors.initials: HR
authors.lastname: Aslanian
authors.affiliation: 1] Section of Digestive Disease, Yale School of Medicine, New Haven, Connecticut, USA [2] VA Connecticut Healthcare System, West Haven, Connecticut, USA.
authors.forename: Loren
authors.initials: L
authors.lastname: Laine
authors.affiliation: Section of Digestive Disease, Yale School of Medicine, New Haven, Connecticut, USA.
authors.forename: James
authors.initials: J
authors.lastname: Farrell
authors.affiliation: Department of Biostatistics, Yale School of Public Health, New Haven, Connecticut, USA.
authors.forename: Maria M
authors.initials: MM
authors.lastname: Ciarleglio
authors.affiliation: Yale Center for Analytical Sciences, Yale School of Public Health, New Haven, Connecticut, USA.
authors.forename: Yanhong
authors.initials: Y
authors.lastname: Deng
authors.affiliation: Section of Digestive Disease, Yale School of Medicine, New Haven, Connecticut, USA.
authors.forename: Henry
authors.initials: H
authors.lastname: Ho
authors.affiliation: Section of Digestive Disease, Yale School of Medicine, New Haven, Connecticut, USA.
authors.forename: Priya A
authors.initials: PA
authors.lastname: Jamidar
mesh_terms: D065638:Absorption, Radiation; D002760:Cholangiopancreatography, Endoscopic Retrograde; D004311:Double-Blind Method; D005123:Eye; D005471:Fluoroscopy; D005762:Gastroenterology; D006801:Humans; D009333:Neck; D009740:Nursing Staff; D016273:Occupational Exposure / Q000517:prevention & control*; D011446:Prospective Studies; D011482:Protective Devices; D011829:Radiation Dosage; D011835:Radiation Protection / Q000295:instrumentation / Q000379:methods*
references.citation: Gastrointest Endosc. 2001 Feb;53(2):161-4
references.pmid: 11174284
references.citation: Eur J Vasc Endovasc Surg. 2014 Mar;47(3):268-72
references.pmid: 24445087
references.citation: Gastroenterol Res Pract. 2014;2014:926876
references.pmid: 25477956
references.citation: J Invasive Cardiol. 2005 Sep;17(9):469-72
references.pmid: 16145234
references.citation: J Vasc Interv Radiol. 2006 Jul;17(7):1201-6
references.pmid: 16868175
references.citation: Br J Radiol. 2002 May;75(893):435-43
references.pmid: 12036837
references.citation: Gastroenterol Clin Biol. 1993;17(4):259-63
references.pmid: 8339884
references.citation: Catheter Cardiovasc Interv. 2012 Jan 1;79(1):97-102
references.pmid: 21520391
references.citation: Radiology. 1979 Mar;130(3):773-5
references.pmid: 424556
references.citation: Int J Cardiol. 2013 Sep 1;167(5):1843-7
references.pmid: 22608271
references.citation: Europace. 2010 Dec;12(12):1769-73
references.pmid: 21097481
references.citation: Gastrointest Endosc. 2007 Jul;66(1):84-9
references.pmid: 17591479
references.citation: Gastrointest Endosc. 1996 Jan;43(1):1-5
references.pmid: 8903808
references.citation: J Vasc Interv Radiol. 2013 Feb;24(2):197-204
references.pmid: 23369556
references.citation: Am J Gastroenterol. 2002 Apr;97(4):893-7
references.pmid: 12003424
references.citation: Surg Endosc. 1997 Jun;11(6):615-7
references.pmid: 9171117
references.citation: Am J Gastroenterol. 2014 Aug;109(8):1180-94
references.pmid: 24842339
references.citation: Postgrad Med J. 2005 Oct;81(960):660-2
references.pmid: 16210465
references.citation: Gastrointest Endosc. 2010 Jul;72(1):58-65
references.pmid: 20421102
references.citation: Korean J Gastroenterol. 2011 Jan;57(1):28-33
references.pmid: 21258198
references.citation: Gastrointest Endosc. 2002 Apr;55(4):552-7
references.pmid: 11923771
references.citation: Br J Radiol. 1998 Jul;71(847):728-33
references.pmid: 9771383
references.citation: Gastrointest Endosc. 2010 Jul;72(1):50-7
references.pmid: 20620272
references.citation: Clin Radiol. 2004 Jun;59(6):468-73
references.pmid: 15145716
references.citation: Radiat Prot Dosimetry. 2003;106(3):241-6
references.pmid: 14690325
references.citation: Gastrointest Endosc. 2011 Feb;73(2):415
references.pmid: 21295662
references.citation: Gastrointest Endosc. 1996 Sep;44(3):287-92
references.pmid: 8885348
references.citation: Gastrointest Endosc. 2011 Jul;74(1):161-6
references.pmid: 21704815
references.citation: Ann ICRP. 2010 Dec;40(6):1-102
references.pmid: 22732420
references.citation: Pacing Clin Electrophysiol. 2014 Jul;37(7):828-33
references.pmid: 24697669
references.citation: Catheter Cardiovasc Interv. 2010 Nov 15;76(6):826-34
references.pmid: 20549683
references.citation: Am J Gastroenterol. 2013 Aug;108(8):1224-30
references.pmid: 23912400
references.citation: Dig Dis Sci. 2006 May;51(5):909-14
references.pmid: 16718536
references.citation: Br J Radiol. 2013 Feb;86(1022):20120289
references.pmid: 23385992
references.citation: Am J Cardiol. 2011 Nov 15;108(10):1408-10
references.pmid: 21861961
references.citation: Hepatogastroenterology. 2012 May;59(115):709-12
references.pmid: 22155794
references.citation: Br J Radiol. 2009 Jan;82(973):1-12
references.pmid: 18852213
references.citation: Ann ICRP. 2000;30(2):7-67
references.pmid: 11459599