Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Radiation Exposure During Endoscopic Retrograde Cholangiopancreatography Between Prone and Left Lateral Decubitus

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Chulalongkorn University
ClinicalTrials.gov Identifier:
NCT01599351
First received: May 14, 2012
Last updated: May 15, 2012
Last verified: May 2012

May 14, 2012
May 15, 2012
July 2009
January 2010   (final data collection date for primary outcome measure)
Patients' entrance surface dose [ Time Frame: within 12 hours after procedure ] [ Designated as safety issue: Yes ]
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.
Same as current
Complete list of historical versions of study NCT01599351 on ClinicalTrials.gov Archive Site
Endoscopists' radiation dose [ Time Frame: Within 12 hours after procedure ] [ Designated as safety issue: Yes ]
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).
Same as current
Not Provided
Not Provided
 
Radiation Exposure During Endoscopic Retrograde Cholangiopancreatography Between Prone and Left Lateral Decubitus
Different Radiation Exposures to Patient and Endoscopists Between Performing ERCP in Patients Lying Prone and Left Lateral Decubitus

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Exposure to Ionizing Radiation
Radiation: The radiographic-fluoroscopic system
Fluoroscopy was used during ERCP procedure. With automatic brightness adjustment, patients with thicker body will get greater radiation dose.
Other Name: Siemens Model Polystar
  • Active Comparator: Prone
    Patients were in prone position along the ERCP procedure.
    Intervention: Radiation: The radiographic-fluoroscopic system
  • Active Comparator: Left lateral decubitus
    Patients were in left lateral decubitus along the ERCP procedure.
    Intervention: Radiation: The radiographic-fluoroscopic system
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
January 2010
January 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Thailand
 
NCT01599351
PA-E-RAD001
No
Chulalongkorn University
Chulalongkorn University
Not Provided
Principal Investigator: Phonthep Angsuwatcharakon, MD, MSc Chulalongkorn University
Chulalongkorn University
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP