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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| sterile identical sham drape | Active Comparator | Sham drape and conventional protection (wearing a lead apron and thyroid shield as well as suspension of a standard lead skirt over the X-ray source). |
|
| lead-free protective drape containing bismuth and antimony | Experimental | lead-free protective drape containing bismuth and antimony (RADPAD®) hung around the fluoroscopy image intensifier to prevent scatter radiation, and conventional protection (wearing a lead apron and thyroid shield as well as suspension of a standard lead skirt over the X-ray source). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lead-free protective drape containing bismuth and antimony (RADPAD®) | Device |
| ||
| Measure | Description | Time Frame |
|---|---|---|
| Amount of radiation exposure | 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. | Length of Endoscopic retrograde cholangiopancreatography, average 5 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Estimate cumulative annual radiation risk | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Priya Jamidar, MD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Endoscopy Center, Smilow Cancer Center, Yale New Haven Hospital | New Have | Connecticut | 06510 | United States |
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| Label | URL |
|---|---|
| A Double-Blind, Randomized, Sham-Controlled Trial of the Effect of a Radiation-Attenuating Drape on Radiation Exposure to Endoscopy Staff During ERCP | View source |
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| sterile identical sham drape |
| Device |
|
| Length of Endoscopic retrograde cholangiopancreatography, average 5 minutes |