Radiation Exposure
Conditions
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.
Interventions
DEVICElead-free protective drape containing bismuth and antimony (RADPAD®)
DEVICEsterile identical sham drape
Sponsors
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
45 Years to 50 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Amount of radiation exposure | 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
| Measure | Time frame | Description |
|---|---|---|
| Estimate cumulative annual radiation risk | 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. The cumulative estimated annual absorbed radiation dose was estimated from the data collected during the study time frame. |
Countries
United States
Outcome results
None listed