Digestive Endoscopy Suite Radiation Controlling Protective Strategies

Radiation Exposure Clinical Trial

— D-ERCP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02063841
• Other study ID #: 1210010994.Jamidar
• Status: Completed
• Phase: Phase 0
• First received: February 12, 2014
• Last updated: August 18, 2015
• Start date: August 2013
• Est. completion date: November 2013

Study information

• Verified date: August 2015
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years to 50 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Radiation Exposure

Intervention

Device:
• lead-free protective drape containing bismuth and antimony (RADPAD®)

• sterile identical sham drape

Locations

Country	Name	City	State
United States	Endoscopy Center, Smilow Cancer Center, Yale New Haven Hospital	New Have	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes

External Links

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