Digestive Endoscopy Suite Radiation Controlling Protective Strategies

Early Phase 1

Completed

• Conditions: Radiation Exposure
• Interventions: Device: sterile identical sham drape; Device: lead-free protective drape containing bismuth and antimony (RADPAD®)

• Registration Number: NCT02063841
• Lead Sponsor: Yale University

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 Timeline

• Study Start: 2013-08
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Study First Submitted: 2014-02-12
• Study First Submitted QC: 2014-02-12
• Study First Posted: 2014-02-14
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-18
• Last Update Posted: 2015-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2

Inclusion Criteria

• All the ERCP procedures done by the same endoscopist and nurse are enrolled
• Patients age >19

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Exclusion Criteria

• Fluoroscopic procedures other than ERCP were excluded.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
sterile identical sham drape	sterile identical sham drape	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	lead-free protective drape containing bismuth and antimony (RADPAD®)	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).

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Endoscopy Center, Smilow Cancer Center, Yale New Haven Hospital; 🇺🇸 New Have, Connecticut, United States