Occupational Radiation Exposure
Conditions
Keywords
radiation exposure, ERCP, prone, left lateral decubitus
Brief summary
X-ray beam produced during endoscopic retrograde cholangiopancreatography (ERCP) affect not only the patient, but the personnel of ERCP team may have the effect from the scattered ray. According to the automatic beam adjustment function, the thicker object (eg. lying left lateral) might produce higher scatter ray than thinner object (eg. lying prone). The investigators evaluate the radiation exposure among ERCP personnel compare between patient's 2 different positions.
Detailed description
Personal solid-state dosimeters were used to measure the radiation dose on personnel during ERCP procedure. The real-time effective doses were displayed at a monitoring screen. A dosimeter was attached outside thyroid collar of each ERCP team member included of 1st endoscopist, 2nd endoscopist, and nurse anesthetist. Patients' age, gender, BMI, body thickness, and indications for ERCP were recorded. The patients were randomized into 2 groups by block-of-four. The patients' position was assigned to prone or left lateral decubitus. Each ERCP personnel wore a lead apron and the dosimeter was attached outside the thyroid collar. The ERCP procedure was performed according to the indication in a standard technique. After ERCP procedure, the total fluoroscopic time (minute), fluoroscopy tube voltage (kV), fluoroscopy tube current (mA), patient entrance skin dose (mGy) and personnel effective dose (Sv) from each dosimeter were recorded. Continuous variables were compared by Student's t-test or Man Whitney U-test, where appropriate. Categorical variables were compared by Chi-square or the Fisher exact test. Statistical analysis was calculated by using SPSS statistical software (version17 for Window, Chicago, USA) and two sided p-value \< 0.05 was considered to be statistical significant.
Interventions
RADIATIONAutomatic beam adjustment function
The fluoroscopy system has an automatic beam adjustment function to maintain a good quality of image output.
Sponsors
Chulalongkorn University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Indicated for ERCP
Exclusion criteria
* pregnancy * American Society of Anesthesiologists (ASA) physical status class III - IV * unstable vital signs * patients' position needed to be changed during the procedure * patients who need fixed position for ERCP (such as biliary hilar lesion) * enteroscope-assisted ERCP * the consent form can not be obtained
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effective Radiation Dose | Immediate after procedure | The effective radiation which represents equivalent dose to eye lens of each personnel were compared between 2 groups. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Left Lateral Decubitus In this group, the position will be assigned to Left lateral decubitus during ERCP. The radiation from fluoroscopy will be adjusted by automatic beam adjustment function to obtain the image quality.
Automatic beam adjustment function: The fluoroscopy system has an automatic beam adjustment function to maintain a good quality of image output. | 27 |
| Prone In this group, the position will be assigned to Prone during ERCP. The radiation from fluoroscopy will be adjusted by automatic beam adjustment function to obtain the image quality.
Automatic beam adjustment function: The fluoroscopy system has an automatic beam adjustment function to maintain a good quality of image output. | 27 |
| Total | 54 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Protocol Violation | 0 | 1 |
Baseline characteristics
| Characteristic | Prone | Total | Left Lateral Decubitus |
|---|---|---|---|
| Age, Continuous | 67 years | 67 years | 67 years |
| BMI | 22.2 kg/m2 STANDARD_DEVIATION 4.07 | 22.5 kg/m2 STANDARD_DEVIATION 3.77 | 22.9 kg/m2 STANDARD_DEVIATION 3.45 |
| Dose area product | 23.2 Gy-cm2 | 22.65 Gy-cm2 | 22.3 Gy-cm2 |
| Fluoroscopy time | 4.14 min | 4.11 min | 4.06 min |
| Indication for ERCP Benign biliary obstruction | 2 Participants | 5 Participants | 3 Participants |
| Indication for ERCP Choledocholithiasis | 17 Participants | 35 Participants | 18 Participants |
| Indication for ERCP Malignant biliary obstruction | 8 Participants | 14 Participants | 6 Participants |
| Patient entrance skin dose | 5.5 mGy/min | 5.6 mGy/min | 5.7 mGy/min |
| Sex: Female, Male Female | 12 Participants | 29 Participants | 17 Participants |
| Sex: Female, Male Male | 15 Participants | 25 Participants | 10 Participants |
| Vertical thickness | 20.2 cm STANDARD_DEVIATION 4.18 | 23.7 cm STANDARD_DEVIATION 5.31 | 27.2 cm STANDARD_DEVIATION 3.71 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 27 | 0 / 27 |
| other Total, other adverse events | 0 / 27 | 0 / 27 |
| serious Total, serious adverse events | 0 / 27 | 0 / 27 |
Outcome results
Primary
Effective Radiation Dose
The effective radiation which represents equivalent dose to eye lens of each personnel were compared between 2 groups.
Time frame: Immediate after procedure
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Left Lateral Decubitus | Effective Radiation Dose | 0.0307 mSv |
| Prone | Effective Radiation Dose | 0.0192 mSv |