Digestive Endoscopy Suite Radiation Controlling Protective Strategies

NCT ID: NCT02063841

Last Updated: 2015-08-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2013-11-30

Brief Summary

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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

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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.

Conditions

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Radiation Exposure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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).

Group Type ACTIVE_COMPARATOR

sterile identical sham drape

Intervention Type DEVICE

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).

Group Type EXPERIMENTAL

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

Intervention Type DEVICE

Interventions

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

Intervention Type DEVICE

sterile identical sham drape

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

45 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yale University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Priya Jamidar, MD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

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Endoscopy Center, Smilow Cancer Center, Yale New Haven Hospital

New Have, Connecticut, United States

Site Status

Countries

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United States

Related Links

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http://www.nature.com/ajg/journal/vaop/ncurrent/full/ajg201585a.html

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

Other Identifiers

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1210010994.Jamidar

Identifier Type: -

Identifier Source: org_study_id

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