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

Exposure to Ionizing Radiation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01599351
• Other study ID #: PA-E-RAD001
• Status: Completed
• Phase: Phase 4
• First received: May 14, 2012
• Last updated: May 15, 2012
• Start date: July 2009
• Est. completion date: January 2010

Study information

• Verified date: May 2012
• Source: Chulalongkorn University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Exposure to Ionizing Radiation

Intervention

Radiation:
• The radiographic-fluoroscopic system
Fluoroscopy was used during ERCP procedure. With automatic brightness adjustment, patients with thicker body will get greater radiation dose.

Locations

Country	Name	City	State
Thailand	King Chulalongkorn Memorial Hospital	Patumwan	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Chulalongkorn University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	within 12 hours after procedure	Yes
Secondary	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).	Within 12 hours after procedure	Yes