Digestive Endoscopy Suite Radiation Controlling Protective Strategies (D-ERCP)

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

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.

Study Overview

• Status: Completed
• Conditions: Radiation Exposure
• Intervention / Treatment: Device: sterile identical sham drape; Device: lead-free protective drape containing bismuth and antimony (RADPAD®)

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 Type: Interventional
• Enrollment (Actual): 2
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Have, Connecticut, United States, 06510
      • Endoscopy Center, Smilow Cancer Center, Yale New Haven Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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).	Device: sterile identical sham drape
Experimental: lead-free protective drape containing bismuth and antimony; 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).	Device: lead-free protective drape containing bismuth and antimony (RADPAD®)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	Length of Endoscopic retrograde cholangiopancreatography, average 5 minutes

Collaborators and Investigators

• Sponsor: Yale University
• Investigators: Principal Investigator: Priya Jamidar, MD, Yale University

Publications and helpful links

Helpful Links

• A Double-Blind, Randomized, Sham-Controlled Trial of the Effect of a Radiation-Attenuating Drape on Radiation Exposure to Endoscopy Staff During ERCP

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (Actual): November 1, 2013
• Study Completion (Actual): November 1, 2013

Study Registration Dates

• First Submitted: February 12, 2014
• First Submitted That Met QC Criteria: February 12, 2014
• First Posted (Estimate): February 14, 2014

Study Record Updates

• Last Update Posted (Estimate): August 20, 2015
• Last Update Submitted That Met QC Criteria: August 18, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Gastrointestinal Agents; Antacids; Bismuth
• Other Study ID Numbers: 1210010994.Jamidar