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Clinical Trials/NCT01599351
NCT01599351
Completed
Phase 4

Different Radiation Exposures to Patient and Endoscopists Between Performing ERCP in Patients Lying Prone and Left Lateral Decubitus

Chulalongkorn University1 site in 1 country40 target enrollmentStarted: July 2009Last updated:

Overview

Phase
Phase 4
Status
Completed
Enrollment
40
Locations
1
Primary Endpoint
Patients' entrance surface dose

Overview

Brief Summary

The objective of this study is to evaluate the radiation dose to patient at two positions (prone and left lateral) and to medical staff during Endoscopic retrograde cholangiopancreatography (ERCP) procedure using dose area product (DAP) meter and thermoluminescent dosimeter (TLD). Data were recorded on 20 patients at prone position and 20 patients at left lateral position.

Detailed Description

The radiographic-fluoroscopic system manufactured by Siemens Model POLYSTAR was used for ERCP procedure at King Chulalongkorn Memorial Hospital. Dose Area Product (DAP) manufactured by PTW Model DIAMENTOR E, a transmission ionization chamber was attached to X-ray collimator to record the dose-area (cGy.cm2) in order to determine the entrance surface air kerma (ESAK, mGy) of the patients at two positions (prone and left lateral) while the Kodak Portal Pack for localization imaging was placed on the patient's couch to determine the exposed area (cm2) on the surface of the patient. TLD was attached at five positions, left eye, thyroid, left forearm, lower abdomen and left leg of the medical staff during ERCP procedure.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Patients with common bile duct (CBD) stone and underwent ERCP
  • age over 18 years
  • ASA class I-II

Exclusion Criteria

  • Abnormal coagulation
  • ASA class III-IV
  • Emergency/urgency conditions
  • Unstable vital signs
  • Denied to participate the study

Outcomes

Primary Outcomes

Patients' entrance surface dose

Time Frame: within 12 hours after procedure

Transparent ionization chamber was placed at the light beam diaphragm of the x-ray tube to measure the dose in the air and the verification film was placed on the couch at fluoroscopic area to determine exposed area. Patient's dose-area product will express in cGy.cm2.

Secondary Outcomes

  • Endoscopists' radiation dose(Within 12 hours after procedure)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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