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
  Purpose

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.


Condition Intervention Phase
Exposure to Ionizing Radiation
Radiation: The radiographic-fluoroscopic system
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Different Radiation Exposures to Patient and Endoscopists Between Performing ERCP in Patients Lying Prone and Left Lateral Decubitus

Resource links provided by NLM:


Further study details as provided by Chulalongkorn University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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).


Enrollment: 40
Study Start Date: July 2009
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Prone
Patients were in prone position along the ERCP procedure.
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: Left lateral decubitus
Patients were in left lateral decubitus along the ERCP procedure.
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01599351

Locations
Thailand
King Chulalongkorn Memorial Hospital
Patumwan, Bangkok, Thailand, 10330
Sponsors and Collaborators
Chulalongkorn University
Investigators
Principal Investigator: Phonthep Angsuwatcharakon, MD, MSc Chulalongkorn University
  More Information

No publications provided

Responsible Party: Chulalongkorn University
ClinicalTrials.gov Identifier: NCT01599351     History of Changes
Other Study ID Numbers: PA-E-RAD001
Study First Received: May 14, 2012
Last Updated: May 15, 2012
Health Authority: Thailand: Ethical Committee

Keywords provided by Chulalongkorn University:
Radiation exposure
ERCP

ClinicalTrials.gov processed this record on November 27, 2014