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OpenTrials
Completed

NCT Number: NCT02063841

Digestive Endoscopy Suite Radiation Controlling Protective Strategies

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.

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Key information

Conditions

Radiation Exposure

Age range

45 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Endoscopy Center, Smilow Cancer Center, Yale New Haven Hospital

New Have, Connecticut, 06510, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Device

sterile identical sham drape

Device

Primary outcomes

  1. Amount of radiation exposure

    Time frame: 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 outcomes

  1. Estimate cumulative annual radiation risk

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Registry information

Official study 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

Acronym: D-ERCP

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Feb 14, 2014
Registry last updated
Aug 20, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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