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Completed

NCT Number: NCT01599351

Radiation Exposure During Endoscopic Retrograde Cholangiopancreatography Between 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.

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Key information

Conditions

Exposure to Ionizing Radiation

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

King Chulalongkorn Memorial Hospital

Patumwan, Bangkok, 10330, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

The radiographic-fluoroscopic system

Radiation

Fluoroscopy was used during ERCP procedure. With automatic brightness adjustment, patients with thicker body will get greater radiation dose.

Other names: Siemens Model Polystar

Primary outcomes

  1. 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

  1. Endoscopists' radiation dose

    Time frame: Within 12 hours after procedure

    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).

Sponsors and collaborators

Lead sponsor

Chulalongkorn University

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
May 16, 2012
Registry last updated
May 16, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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