Cholangiopancreatography, Endoscopic RetrogradePhase 3NCT02985164
Radiation Exposure During Endoscopic Retrograde Cholangiopancreatography
A Phase 3 study testing PDSa and PDSb in people with Cholangiopancreatography, Endoscopic Retrograde and Occupational Exposure, run by Siriraj Hospital.
Trial summary
Radiation now becomes a dreadful effect as its outcomes are tremendous to be expected. As a result, anesthetists become an inevitable target to the radiation exposure since they have to monitor patients closely during the operation. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cholangiopancreatography, Endoscopic Retrograde, Occupational Exposure, Radiation Injuries
- What is being tested?
- PDSa and PDSb
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 222 participants
- Where
- No sites listed yet
- Study dates
- Sep 2015to Dec 2016
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- The patient who underwent ERCP
Who cannot join
- None
About this study
Official title: Radiation Exposure Affecting Anaesthesia Personnel During Endoscopic Retrograde Cholangiopancreatography
Radiation now becomes a dreadful effect as its outcomes are tremendous to be expected. As a result, anesthetists become an inevitable target to the radiation exposure since they have to monitor patients closely during the operation. Unfortunately, radiation may not have an immediate sequelae, but an accumulation of adverse effects.
These sequelae happen by means of direct exposure and reflection. The reflected rays is inversely proportional to the distance between the origin and the target. Practically, the radiation source can be protected by individual cover and glass shield.
Read more
Siriraj hospital is a tertiary, general university hospital with 2,200 beds. Annually, an Endoscopy centre has over 700 patients undergoing endoscopic retrograde cholangio pancreaticography (ERCP). Normally, fluoroscopy for pancreatic and biliary ducts visualisation is needed under anesthesia. Though the procedure is operated in a well-equipped, radiating-protection room; many medical personnel including 1-2 endoscopists, 2 scrub nurses, 1-2 anesthetists and 1 x-ray man, still have a chance of irradiation.
During ERCP, all medical personnel particularly anesthetists are rinsed by radiation from here and there. Though they always wear lead aprons and collar shields to protect themselves from the rays, they are normally in the position - less than 1 meter - close to the fluoroscopy.
Due to the advancement in technology, anesthetists can remotely monitor patients during the surgical procedure. This might cause a lesser effect of ray upon them. As a result, whether or not the positioning of anesthesia personnel relating to the distance of x-ray source would help to alleviate the effect of radiation exposure.
Read the detailed description
This study has been approved by Siriraj IRB. Inclusion criteria were the patient who underwent ERCP procedure. Exclusion criteria were none. The project was terminated when 19 August 2016 A total of 222 cases was included without the need of informed consent.
At the Endoscopic unit A nurse anesthetist performed venous cannulation on the right forearm and transfused with 5% dextrose in half-strength normal saline. Then the patient was transferred to the ERCP theatre.
The patient was monitored with non-invasive blood pressure (NIBP), percutaneous arterial oxygen saturation (SpO2), and electrocardiogram (EKG) and administered with oxygen 3LPM via nasal cannula.
A co-researcher reset and prepared 4 pocket dosimeters (PDS) and labelled as PDSa1, PDSa2, PDSb1 and PDSb2.
The PDSa1 and PDSa2 were placed on the outside and inside of a lead shirt respectively. The shirt-covered box was close to an anesthetic machine. This box would represent anesthetic personnel on duty and marked as position A.
The PDSb1 and PDSb2 were placed on the outside and inside of the glass shield of control room respectively. This glass shield would represent all personnel working in the operating theatre and marked as position B.
Both position A and B were 160 cm. above the floor. After an anesthesiologist administered a narcotic and an induction agent to a patient (total intravenous anaesthesia, TIVA), an endoscopist commenced the procedure. A co-researcher turned on all PDS devices as soon as the surgeon started a fluoroscopy, and turned it off whenever the use of radiative source was over. When the study was completed, the PDA devices was kept in a solid and dry place. The lead apron was hanged in the specific area and covered by a bag.
The devices
A lead apron was 0.5 mm. and 0.25 mm. in thickness on the front and back (BT medical) respectively. A thyroid shield was 0.5 mm. in thickness. A paper box was 30x1510 cm. in dimension. A radiative dosimeter (Ludlum model 25-IS \&25-IS-1 Personal Radiation Monitor, 501 Oak street, Sweetwater, Texas, USA) had characteristic details as follow:
Ludlum model 25-IS \& Model 25-IS-1 Radiation detected Gamma (X ray) typically < 18 count per minute per milliroentgen/hr.
Beta response typically < 0.10 milliroentgen/hr Display range For 25-IS: 0.01 milliroentgen/hr to 10 sievert/hr For 25-IS-1: 0.01 millisievert/hr to 10 sievert/hr Size. 7.6 x5.4x1.7 cm (H x W x thickness) Weight. 158.6 g. Including batteries Linearity. Reading within 10% of true value within calibration range
Analysis of data Data were expressed as mean and standard deviation and analysed by using SPSS version 18.0. Categorical data were compared by using Chi-square test; while, the recorded data using dependent t-test. A p < 0.05 was considered statistically significant difference at 95% confidence interval.
- Conditions
- Cholangiopancreatography, Endoscopic Retrograde, Occupational Exposure, Radiation Injuries
- Being tested
- PDSa, PDSb
- Keywords
- Anesthesiology( H02.403.066 ), Radiation Protection( N06.850.810.425), Cholangiopancreatography, Endoscopic Retrograde(D002760 )
- Medical subject headings
- Radiation Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PDSaRadiation
After an anesthesiologist administered a narcotic and an induction agent to a patient (total intravenous anesthesia, TIVA), an endoscopist commenced the procedure. A co-researcher turned on Pocket Radiation Dosimeter label as PDSa1 (outside lead apron),PDSa2 (inside lead apron).
PDSbRadiation
After an anesthesiologist administered a narcotic and an induction agent to a patient (total intravenous anesthesia, TIVA), an endoscopist commenced the procedure. A co-researcher turned on Pocket Radiation Dosimeter label as PDSb1 (outside lead apron), PDSb2 (inside lead apron).
| Study group | Role | What they receive |
|---|---|---|
| PDSa (Pocket radiation dosimeter a) | Experimental | A co-researcher reset and prepared 4 pocket dosimeters (PDS) and labelled as PDSa1, PDSa2, PDSb1 and PDSb2.
The PDSa1 and PDSa2 were placed on the outside and inside of a lead shirt respectively. The shirt-covered box was close to an anesthetic machine. This box would represent anesthetic personnel on duty and marked as position A. Position A was 160 cm. above the floor Receives: Radiation: PDSa |
| PDSb (Pocket radiation dosimeter b) | Experimental | The PDSb1 and PDSb2 were placed on the outside and inside of the glass shield of control room respectively. This glass shield would represent all personnel working in the operating theatre and marked as position B.
Position B was 160 cm. above the floor. Receives: Radiation: PDSb |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of radiative difference
The amount of radiative difference on the outside of the shirt-covered box and the glass shield as compared to the inside.
Measured: up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2016 (estimated)
- Study startSep 2015
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Cholangiopancreatography, Endoscopic RetrogradeStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 222 participants (actual)
Sponsor and investigators
- Lead sponsor
- Siriraj Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Phawan Suton, Siriraj Hospital
- Investigators
- Department of Anesthesiology Siriraj Hospital, Study director, Department of Anesthesia, Faculty of Medicine Siriraj Hospital, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02985164
- Sponsor's protocol ID
- 270/2558(EC2)
- Status last verified
- Dec 2016
- First submitted
- 27 Nov 2016
- Last updated
- 7 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
ASGE Technology Committee; Pedrosa MC, Farraye FA, Shergill AK, Banerjee S, Desilets D, Diehl DL, Kaul V, Kwon RS, Mamula P, Rodriguez SA, Varadarajulu S, Song LM, Tierney WM. Minimizing occupational hazards in endoscopy: personal protective equipment, radiation safety, and ergonomics. Gastrointest Endosc. 2010 Aug;72(2):227-35. doi: 10.1016/j.gie.2010.01.071. Epub 2010 May 26.
PubMed 20537638Ismail S, Khan F, Sultan N, Naqvi M. Radiation exposure to anaesthetists during interventional radiology. Anaesthesia. 2010 Jan;65(1):54-60. doi: 10.1111/j.1365-2044.2009.06166.x. Epub 2009 Nov 17.
PubMed 19922509Miller PS, Braiterman LT, Ts'o PO. Effects of a trinucleotide ethyl phosphotriester, Gmp(Et)Gmp(Et)U, on mammalian cells in culture. Biochemistry. 1977 May 3;16(9):1988-96. doi: 10.1021/bi00628a036.
PubMed 557989Markou P. [Fetus radiation doses from nuclear medicine and radiology diagnostic procedures. Potential risks and radiation protection instructions]. Hell J Nucl Med. 2007 Jan-Apr;10(1):48-55. Greek, Modern.
PubMed 17450255Daas AY, Agha A, Pinkas H, Mamel J, Brady PG. ERCP in pregnancy: is it safe? Gastroenterol Hepatol (N Y). 2009 Dec;5(12):851-5.
PubMed 20567530
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiation Exposure Affecting Anaesthesia Personnel During Endoscopic Retrograde Cholangiopancreatography
- ClinicalTrials.gov ID
- NCT02985164
- Acronym / sponsor ID
- 270/2558(EC2)
- Conditions
- Cholangiopancreatography, Endoscopic Retrograde, Occupational Exposure, Radiation Injuries
- Keywords
- Anesthesiology( H02.403.066 ), Radiation Protection( N06.850.810.425), Cholangiopancreatography, Endoscopic Retrograde(D002760 )
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 222 participants (actual)
- Lead sponsor
- Siriraj HospitalUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 7 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Radiation now becomes a dreadful effect as its outcomes are tremendous to be expected. As a result, anesthetists become an inevitable target to the radiation exposure since they have to monitor patients closely during the operation. Unfortunately, radiation may not have an immediate sequelae, but an accumulation of adverse effects.
These sequelae happen by means of direct exposure and reflection. The reflected rays is inversely proportional to the distance between the origin and the target. Practically, the radiation source can be protected by individual cover and glass shield.
Siriraj hospital is a tertiary, general university hospital with 2,200 beds. Annually, an Endoscopy centre has over 700 patients undergoing endoscopic retrograde cholangio pancreaticography (ERCP). Normally, fluoroscopy for pancreatic and biliary ducts visualisation is needed under anesthesia. Though the procedure is operated in a well-equipped, radiating-protection room; many medical personnel including 1-2 endoscopists, 2 scrub nurses, 1-2 anesthetists and 1 x-ray man, still have a chance of irradiation.
During ERCP, all medical personnel particularly anesthetists are rinsed by radiation from here and there. Though they always wear lead aprons and collar shields to protect themselves from the rays, they are normally in the position - less than 1 meter - close to the fluoroscopy.
Due to the advancement in technology, anesthetists can remotely monitor patients during the surgical procedure. This might cause a lesser effect of ray upon them. As a result, whether or not the positioning of anesthesia personnel relating to the distance of x-ray source would help to alleviate the effect of radiation exposure.
Detailed description
This study has been approved by Siriraj IRB. Inclusion criteria were the patient who underwent ERCP procedure. Exclusion criteria were none. The project was terminated when 19 August 2016 A total of 222 cases was included without the need of informed consent.
At the Endoscopic unit A nurse anesthetist performed venous cannulation on the right forearm and transfused with 5% dextrose in half-strength normal saline. Then the patient was transferred to the ERCP theatre.
The patient was monitored with non-invasive blood pressure (NIBP), percutaneous arterial oxygen saturation (SpO2), and electrocardiogram (EKG) and administered with oxygen 3LPM via nasal cannula.
A co-researcher reset and prepared 4 pocket dosimeters (PDS) and labelled as PDSa1, PDSa2, PDSb1 and PDSb2.
The PDSa1 and PDSa2 were placed on the outside and inside of a lead shirt respectively. The shirt-covered box was close to an anesthetic machine. This box would represent anesthetic personnel on duty and marked as position A.
The PDSb1 and PDSb2 were placed on the outside and inside of the glass shield of control room respectively. This glass shield would represent all personnel working in the operating theatre and marked as position B.
Both position A and B were 160 cm. above the floor. After an anesthesiologist administered a narcotic and an induction agent to a patient (total intravenous anaesthesia, TIVA), an endoscopist commenced the procedure. A co-researcher turned on all PDS devices as soon as the surgeon started a fluoroscopy, and turned it off whenever the use of radiative source was over. When the study was completed, the PDA devices was kept in a solid and dry place. The lead apron was hanged in the specific area and covered by a bag.
The devices
A lead apron was 0.5 mm. and 0.25 mm. in thickness on the front and back (BT medical) respectively. A thyroid shield was 0.5 mm. in thickness. A paper box was 30x1510 cm. in dimension. A radiative dosimeter (Ludlum model 25-IS \&25-IS-1 Personal Radiation Monitor, 501 Oak street, Sweetwater, Texas, USA) had characteristic details as follow:
Ludlum model 25-IS \& Model 25-IS-1 Radiation detected Gamma (X ray) typically < 18 count per minute per milliroentgen/hr.
Beta response typically < 0.10 milliroentgen/hr Display range For 25-IS: 0.01 milliroentgen/hr to 10 sievert/hr For 25-IS-1: 0.01 millisievert/hr to 10 sievert/hr Size. 7.6 x5.4x1.7 cm (H x W x thickness) Weight. 158.6 g. Including batteries Linearity. Reading within 10% of true value within calibration range
Analysis of data Data were expressed as mean and standard deviation and analysed by using SPSS version 18.0. Categorical data were compared by using Chi-square test; while, the recorded data using dependent t-test. A p < 0.05 was considered statistically significant difference at 95% confidence interval.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PDSa (Pocket radiation dosimeter a) | Experimental | Radiation: PDSaA co-researcher reset and prepared 4 pocket dosimeters (PDS) and labelled as PDSa1, PDSa2, PDSb1 and PDSb2. The PDSa1 and PDSa2 were placed on the outside and inside of a lead shirt respectively. The shirt-covered box was close to an anesthetic machine. This box would represent anesthetic personnel on duty and marked as position A. Position A was 160 cm. above the floor |
| PDSb (Pocket radiation dosimeter b) | Experimental | Radiation: PDSbThe PDSb1 and PDSb2 were placed on the outside and inside of the glass shield of control room respectively. This glass shield would represent all personnel working in the operating theatre and marked as position B. Position B was 160 cm. above the floor. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- The patient who underwent ERCP
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| PDSaAfter an anesthesiologist administered a narcotic and an induction agent to a patient (total intravenous anesthesia, TIVA), an endoscopist commenced the procedure. A co-researcher turned on Pocket Radiation Dosimeter label as PDSa1 (outside lead apron),PDSa2 (inside lead apron). | Radiation | PDSa (Pocket radiation dosimeter a) |
| PDSbAfter an anesthesiologist administered a narcotic and an induction agent to a patient (total intravenous anesthesia, TIVA), an endoscopist commenced the procedure. A co-researcher turned on Pocket Radiation Dosimeter label as PDSb1 (outside lead apron), PDSb2 (inside lead apron). | Radiation | PDSb (Pocket radiation dosimeter b) |
Primary outcome
Amount of radiative difference
Time frame: up to 1 year
The amount of radiative difference on the outside of the shirt-covered box and the glass shield as compared to the inside.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2016.
- Background: PubMed 20537638ASGE Technology Committee; Pedrosa MC, Farraye FA, Shergill AK, Banerjee S, Desilets D, Diehl DL, Kaul V, Kwon RS, Mamula P, Rodriguez SA, Varadarajulu S, Song LM, Tierney WM. Minimizing occupational hazards in endoscopy: personal protective equipment, radiation safety, and ergonomics. Gastrointest Endosc. 2010 Aug;72(2):227-35. doi: 10.1016/j.gie.2010.01.071. Epub 2010 May 26.
- Background: PubMed 19922509Ismail S, Khan F, Sultan N, Naqvi M. Radiation exposure to anaesthetists during interventional radiology. Anaesthesia. 2010 Jan;65(1):54-60. doi: 10.1111/j.1365-2044.2009.06166.x. Epub 2009 Nov 17.
- Background: PubMed 557989Miller PS, Braiterman LT, Ts'o PO. Effects of a trinucleotide ethyl phosphotriester, Gmp(Et)Gmp(Et)U, on mammalian cells in culture. Biochemistry. 1977 May 3;16(9):1988-96. doi: 10.1021/bi00628a036.
- Background: PubMed 17450255Markou P. [Fetus radiation doses from nuclear medicine and radiology diagnostic procedures. Potential risks and radiation protection instructions]. Hell J Nucl Med. 2007 Jan-Apr;10(1):48-55. Greek, Modern.
- Background: PubMed 20567530Daas AY, Agha A, Pinkas H, Mamel J, Brady PG. ERCP in pregnancy: is it safe? Gastroenterol Hepatol (N Y). 2009 Dec;5(12):851-5.
- Individual participant dataSharing planned: Yes
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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.
Department of Anesthesiology Siriraj Hospital study director
Department of Anesthesia, Faculty of Medicine Siriraj Hospital, Mahidol University
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing PDSa and PDSb in people with Cholangiopancreatography, Endoscopic Retrograde and Occupational Exposure, run by Siriraj Hospital.
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 1 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 7 Dec 2016. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Amount of radiative difference (time frame: up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02985164, which also lists 5 linked publications.
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 7 Dec 2016.