Digestive Endoscopy Suite Radiation Controlling Protective Strategies

NCT02063841 | Completed Early Phase 1

• 1 other identifier: 1210010994.Jamidar
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Radiation Exposure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Estimate cumulative annual radiation risk

  Length of Endoscopic retrograde cholangiopancreatography, average 5 minutes

Study Arms (2)

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).

Device: sterile identical sham drape

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).

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

Interventions

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

lead-free protective drape containing bismuth and antimony

sterile identical sham drape DEVICE

sterile identical sham drape

Eligibility Criteria

• Age: 45 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Fluoroscopic procedures other than ERCP were excluded.

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Endoscopy Center, Smilow Cancer Center, Yale New Haven Hospital

New Have, Connecticut, 06510, United States

Location

Related 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 Officials

• Priya Jamidar, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2014
• First Posted: February 14, 2014
• Study Start: August 1, 2013
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: August 20, 2015

Record last verified: 2015-08

Locations

US (1)