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

Phase 4

Completed

• Conditions: Exposure to Ionizing Radiation
• Interventions: Radiation: The radiographic-fluoroscopic system

• Registration Number: NCT01599351
• Lead Sponsor: Chulalongkorn University

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.

Study Timeline

• Study Start: 2009-07
• Primary Completion: 2010-01
• Study Completion: 2010-01
• Status Verified: 2012-05
• Study First Submitted: 2012-05-14
• Study First Submitted QC: 2012-05-15
• Last Update Submitted: 2012-05-15
• Study First Posted: 2012-05-16
• Last Update Posted: 2012-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prone	The radiographic-fluoroscopic system	Patients were in prone position along the ERCP procedure.
Left lateral decubitus	The radiographic-fluoroscopic system	Patients were in left lateral decubitus along the ERCP procedure.

Primary Outcome Measures

Name	Time	Method
Patients' entrance surface dose	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 Outcome Measures

Name	Time	Method
Endoscopists' radiation dose	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).

Trial Locations

Locations (1)

King Chulalongkorn Memorial Hospital; 🇹🇭 Patumwan, Bangkok, Thailand