Radiation Exposure During Endoscopic Retrograde Cholangiopancreatography Between Prone and Left Lateral Decubitus
Primary Purpose
Exposure to Ionizing Radiation
Status
Completed
Phase
Phase 4
Locations
Thailand
Study Type
Interventional
Intervention
The radiographic-fluoroscopic system
Sponsored by
About this trial
This is an interventional diagnostic trial for Exposure to Ionizing Radiation focused on measuring Radiation exposure, ERCP
Eligibility Criteria
Inclusion Criteria:
- Patients with common bile duct (CBD) stone and underwent ERCP
- age over 18 years
- ASA class I-II
Exclusion Criteria:
- Pregnant
- Abnormal coagulation
- ASA class III-IV
- Emergency/urgency conditions
- Unstable vital signs
- Denied to participate the study
Sites / Locations
- King Chulalongkorn Memorial Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Prone
Left lateral decubitus
Arm Description
Patients were in prone position along the ERCP procedure.
Patients were in left lateral decubitus along the ERCP procedure.
Outcomes
Primary Outcome Measures
Patients' entrance surface dose
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 Outcome Measures
Endoscopists' radiation dose
Thermoluminescent dosimeters (TLD) were placed at left eye, thyroid, left forearm, lower abdomen, and left leg of endoscopists. The TLDs used in this study was TLD-100 which was lithium fluoride crystal doped with magnesium and titanium (LiF:Mg, Ti). After procedures all labeled TLDs were read by automatic TLD reader (Harshaw 5500, Thermo Scientific Corp., MA, USA).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01599351
Brief Title
Radiation Exposure During Endoscopic Retrograde Cholangiopancreatography Between Prone and Left Lateral Decubitus
Official Title
Different Radiation Exposures to Patient and Endoscopists Between Performing ERCP in Patients Lying Prone and Left Lateral Decubitus
Study Type
Interventional
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
January 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chulalongkorn University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Exposure to Ionizing Radiation
Keywords
Radiation exposure, ERCP
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Prone
Arm Type
Active Comparator
Arm Description
Patients were in prone position along the ERCP procedure.
Arm Title
Left lateral decubitus
Arm Type
Active Comparator
Arm Description
Patients were in left lateral decubitus along the ERCP procedure.
Intervention Type
Radiation
Intervention Name(s)
The radiographic-fluoroscopic system
Other Intervention Name(s)
Siemens Model Polystar
Intervention Description
Fluoroscopy was used during ERCP procedure. With automatic brightness adjustment, patients with thicker body will get greater radiation dose.
Primary Outcome Measure Information:
Title
Patients' entrance surface dose
Description
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.
Time Frame
within 12 hours after procedure
Secondary Outcome Measure Information:
Title
Endoscopists' radiation dose
Description
Thermoluminescent dosimeters (TLD) were placed at left eye, thyroid, left forearm, lower abdomen, and left leg of endoscopists. The TLDs used in this study was TLD-100 which was lithium fluoride crystal doped with magnesium and titanium (LiF:Mg, Ti). After procedures all labeled TLDs were read by automatic TLD reader (Harshaw 5500, Thermo Scientific Corp., MA, USA).
Time Frame
Within 12 hours after procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with common bile duct (CBD) stone and underwent ERCP
age over 18 years
ASA class I-II
Exclusion Criteria:
Pregnant
Abnormal coagulation
ASA class III-IV
Emergency/urgency conditions
Unstable vital signs
Denied to participate the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Phonthep Angsuwatcharakon, MD, MSc
Organizational Affiliation
Chulalongkorn University
Official's Role
Principal Investigator
Facility Information:
Facility Name
King Chulalongkorn Memorial Hospital
City
Patumwan
State/Province
Bangkok
ZIP/Postal Code
10330
Country
Thailand
12. IPD Sharing Statement
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Radiation Exposure During Endoscopic Retrograde Cholangiopancreatography Between Prone and Left Lateral Decubitus
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