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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Left lateral decubitus | Active Comparator | 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. |
|
| Prone | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Automatic beam adjustment function | Radiation | The fluoroscopy system has an automatic beam adjustment function to maintain a good quality of image output. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Effective Radiation Dose | The effective radiation which represents equivalent dose to eye lens of each personnel were compared between 2 groups. | Immediate after procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rungsun Rerknimitr, MD, FRCP | Chulalongkorn University | Principal Investigator |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Effective Radiation Dose | The effective radiation which represents equivalent dose to eye lens of each personnel were compared between 2 groups. | Posted | Median | Inter-Quartile Range | mSv | Immediate after procedure |
|
1 week
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Phonthep Angsuwatcharakon, MD | Gastroenterology endoscopy center | 6622564265 | borndeb@yahoo.com |
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| BG001 |
| 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| BMI | Mean | Standard Deviation | kg/m2 |
|
| Indication for ERCP | Count of Participants | Participants |
|
| Vertical thickness | Mean | Standard Deviation | cm |
|
| Fluoroscopy time | Median | Inter-Quartile Range | min |
|
| Dose area product | Median | Inter-Quartile Range | Gy-cm2 |
|
| Patient entrance skin dose | Mean | Inter-Quartile Range | mGy/min |
|
|
|
| 0 |
| 27 |
| 0 |
| 27 |
| 0 |
| 27 |
| EG001 | 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. | 0 | 27 | 0 | 27 | 0 | 27 |
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