Occupational Radiation ExposureNCT02791659
Radiation Exposure of ERCP Personnel at Different Standing Locations and Different Patient Positions.
A study testing Automatic beam adjustment function in people with Occupational Radiation Exposure, run by Chulalongkorn University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Occupational Radiation Exposure
- What is being tested?
- Automatic beam adjustment function
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- No sites listed yet
- Study dates
- Jul 2016to Nov 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Indicated for ERCP
Who cannot join
- 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
About this study
Official title: Radiation Exposure of ERCP Personnel at Different Standing Locations and Different Patient Positions (Prone and Left Lateral Decubitus)
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.
Read the 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.
- Conditions
- Occupational Radiation Exposure
- Being tested
- Automatic beam adjustment function
- Keywords
- radiation exposure, ERCP, prone, left lateral decubitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Automatic beam adjustment functionRadiation
The fluoroscopy system has an automatic beam adjustment function to maintain a good quality of image output.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Radiation: Automatic beam adjustment function |
| 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. Receives: Radiation: Automatic beam adjustment function |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effective Radiation Dose
The effective radiation which represents equivalent dose to eye lens of each personnel were compared between 2 groups.
Measured: Immediate after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2016 (estimated)
- Study startJul 2016
- Primary completionOct 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Occupational Radiation ExposureStudies of the same condition, open and under way.
- More trials run by Chulalongkorn UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rungsun Rerknimitr, MD, FRCP, Principal investigator, Chulalongkorn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02791659
- Sponsor's protocol ID
- PA-E-RAD002
- Status last verified
- Apr 2017
- First submitted
- 1 Jun 2016
- Last updated
- 30 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiation Exposure of ERCP Personnel at Different Standing Locations and Different Patient Positions (Prone and Left Lateral Decubitus)
- ClinicalTrials.gov ID
- NCT02791659
- Acronym / sponsor ID
- PA-E-RAD002
- Conditions
- Occupational Radiation Exposure
- Keywords
- radiation exposure, ERCP, prone, left lateral decubitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Study start
- Jul 2016 (actual)
- Primary completion
- Oct 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 7 Jun 2016 (estimated)
- Results
- Posted 22 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Left lateral decubitus | Active comparator | Radiation: Automatic beam adjustment functionIn 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 | Radiation: Automatic beam adjustment functionIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Indicated for ERCP
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Automatic beam adjustment functionThe fluoroscopy system has an automatic beam adjustment function to maintain a good quality of image output. | Radiation | Left lateral decubitus, Prone |
Primary outcome
Effective Radiation Dose
Time frame: Immediate after procedure
The effective radiation which represents equivalent dose to eye lens of each personnel were compared between 2 groups.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rungsun Rerknimitr, MD, FRCP principal investigator
Chulalongkorn University
Questions about this trial
What is this clinical trial studying?
A study testing Automatic beam adjustment function in people with Occupational Radiation Exposure, run by Chulalongkorn University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 May 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effective Radiation Dose (time frame: Immediate after procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2017.