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

Yale University

Status and phase: Completed; Early Phase 1

Conditions: Radiation Exposure

Treatments: Device: sterile identical sham drape; Device: lead-free protective drape containing bismuth and antimony (RADPAD®)

Study type: Interventional

Funder types: Other

Identifiers

NCT02063841

1210010994.Jamidar

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2 patients

Sex: All

Ages: 45 to 50 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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2 participants in 2 patient groups

sterile identical sham drape

Active Comparator group

Description:

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).

Treatment:

Device: sterile identical sham drape

lead-free protective drape containing bismuth and antimony

Experimental group

Description:

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).

Treatment:

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