NCT02063841

Digestive Endoscopy Suite Radiation Controlling Protective Strategies

A Prospective Double-blind, Randomized, Sham-controlled Trial to Evaluate the Effect of a Lead Free Drape on Scatter Radiation Exposure to Endoscopy Staff During Endoscopic Retrograde Cholangiopancreatography

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 45 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

ERCP is associated with radiation exposure to the endoscopist and staff, which may be significant at high volume programs despite the use of lead aprons. We hypothesize that draping of the fluoroscopy image intensifier may significantly reduce staff radiation exposure and help achieve implementation of the ALARA (As Low As Reasonably Achievable) principle.

Detailed description

A total of 100 consecutive ERCP procedures were randomly assigned to the radiation-attenuating or sham drape in a 1:1 ratio. There were 2 subjects, the endoscopists performing ERCP and the nurse assisting in the procedure.

Conditions

• Radiation Exposure

Interventions

Type	Name	Description
DEVICE	lead-free protective drape containing bismuth and antimony (RADPAD®)
DEVICE	sterile identical sham drape

Timeline

• Start date: 2013-08-01
• Primary completion: 2013-11-01
• Completion: 2013-11-01
• First posted: 2014-02-14
• Last updated: 2015-08-20

Locations

1 site across 1 country: United States