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

Chulalongkorn University

Status and phase: Completed; Phase 4

Conditions: Exposure to Ionizing Radiation

Treatments: Radiation: The radiographic-fluoroscopic system

Study type: Interventional

Funder types: Other

Identifiers

NCT01599351

PA-E-RAD001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Prone

Active Comparator group

Description:

Patients were in prone position along the ERCP procedure.

Treatment:

Radiation: The radiographic-fluoroscopic system

Left lateral decubitus

Active Comparator group

Description:

Patients were in left lateral decubitus along the ERCP procedure.

Treatment:

Radiation: The radiographic-fluoroscopic system