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
Trial Snapshot
- Phase
- Early Phase 1
- Status
- Completed
- Sponsor
- Yale University
- Enrollment
- 2
- Locations
- 2
- Primary Endpoint
- Amount of radiation exposure
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 45 Years to 50 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •All the ERCP procedures done by the same endoscopist and nurse are enrolled
- •Patients age >19
Exclusion Criteria
- •Fluoroscopic procedures other than ERCP were excluded.
Outcomes
Primary Outcomes
Amount of radiation exposure
Time Frame: Length of Endoscopic retrograde cholangiopancreatography, average 5 minutes
Comparing the use of a lead-free protective drape containing bismuth and antimony and a sterile sham protective drape, radiation dose (RD) was measured at 3 different sites (endoscopist's eye (1) and thyroid (2), and assisting nurse's thyroid (3)) with personal dosimeters placed outside of eyeglass frames and the thyroid shield. The unit of measurement is each event. The subject was subjected to radiation during 100 Endoscopic retrograde cholangiopancreatography procedures.Both groups used standard of care lead protection.
Secondary Outcomes
- Estimate cumulative annual radiation risk(Length of Endoscopic retrograde cholangiopancreatography, average 5 minutes)