<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02985164</url>
  </required_header>
  <id_info>
    <org_study_id>270/2558(EC2)</org_study_id>
    <nct_id>NCT02985164</nct_id>
  </id_info>
  <brief_title>Radiation Exposure During Endoscopic Retrograde Cholangiopancreatography</brief_title>
  <official_title>Radiation Exposure Affecting Anaesthesia Personnel During Endoscopic Retrograde Cholangiopancreatography</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Siriraj Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Siriraj Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Radiation now becomes a dreadful effect as its outcomes are tremendous to be expected. As a&#xD;
      result, anesthetists become an inevitable target to the radiation exposure since they have to&#xD;
      monitor patients closely during the operation. Unfortunately, radiation may not have an&#xD;
      immediate sequelae, but an accumulation of adverse effects.&#xD;
&#xD;
      These sequelae happen by means of direct exposure and reflection. The reflected rays is&#xD;
      inversely proportional to the distance between the origin and the target. Practically, the&#xD;
      radiation source can be protected by individual cover and glass shield.&#xD;
&#xD;
      Siriraj hospital is a tertiary, general university hospital with 2,200 beds. Annually, an&#xD;
      Endoscopy centre has over 700 patients undergoing endoscopic retrograde cholangio&#xD;
      pancreaticography (ERCP). Normally, fluoroscopy for pancreatic and biliary ducts&#xD;
      visualisation is needed under anesthesia. Though the procedure is operated in a&#xD;
      well-equipped, radiating-protection room; many medical personnel including 1-2 endoscopists,&#xD;
      2 scrub nurses, 1-2 anesthetists and 1 x-ray man, still have a chance of irradiation.&#xD;
&#xD;
      During ERCP, all medical personnel particularly anesthetists are rinsed by radiation from&#xD;
      here and there. Though they always wear lead aprons and collar shields to protect themselves&#xD;
      from the rays, they are normally in the position - less than 1 meter - close to the&#xD;
      fluoroscopy.&#xD;
&#xD;
      Due to the advancement in technology, anesthetists can remotely monitor patients during the&#xD;
      surgical procedure. This might cause a lesser effect of ray upon them. As a result, whether&#xD;
      or not the positioning of anesthesia personnel relating to the distance of x-ray source would&#xD;
      help to alleviate the effect of radiation exposure.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study has been approved by Siriraj IRB. Inclusion criteria were the patient who&#xD;
      underwent ERCP procedure. Exclusion criteria were none. The project was terminated when 19&#xD;
      August 2016 A total of 222 cases was included without the need of informed consent.&#xD;
&#xD;
      At the Endoscopic unit A nurse anesthetist performed venous cannulation on the right forearm&#xD;
      and transfused with 5% dextrose in half-strength normal saline. Then the patient was&#xD;
      transferred to the ERCP theatre.&#xD;
&#xD;
      The patient was monitored with non-invasive blood pressure (NIBP), percutaneous arterial&#xD;
      oxygen saturation (SpO2), and electrocardiogram (EKG) and administered with oxygen 3LPM via&#xD;
      nasal cannula.&#xD;
&#xD;
      A co-researcher reset and prepared 4 pocket dosimeters (PDS) and labelled as PDSa1, PDSa2,&#xD;
      PDSb1 and PDSb2.&#xD;
&#xD;
      The PDSa1 and PDSa2 were placed on the outside and inside of a lead shirt respectively. The&#xD;
      shirt-covered box was close to an anesthetic machine. This box would represent anesthetic&#xD;
      personnel on duty and marked as position A.&#xD;
&#xD;
      The PDSb1 and PDSb2 were placed on the outside and inside of the glass shield of control room&#xD;
      respectively. This glass shield would represent all personnel working in the operating&#xD;
      theatre and marked as position B.&#xD;
&#xD;
      Both position A and B were 160 cm. above the floor. After an anesthesiologist administered a&#xD;
      narcotic and an induction agent to a patient (total intravenous anaesthesia, TIVA), an&#xD;
      endoscopist commenced the procedure. A co-researcher turned on all PDS devices as soon as the&#xD;
      surgeon started a fluoroscopy, and turned it off whenever the use of radiative source was&#xD;
      over. When the study was completed, the PDA devices was kept in a solid and dry place. The&#xD;
      lead apron was hanged in the specific area and covered by a bag.&#xD;
&#xD;
      The devices&#xD;
&#xD;
      A lead apron was 0.5 mm. and 0.25 mm. in thickness on the front and back (BT medical)&#xD;
      respectively. A thyroid shield was 0.5 mm. in thickness. A paper box was 30x1510 cm. in&#xD;
      dimension. A radiative dosimeter (Ludlum model 25-IS &amp;25-IS-1 Personal Radiation Monitor, 501&#xD;
      Oak street, Sweetwater, Texas, USA) had characteristic details as follow:&#xD;
&#xD;
      Ludlum model 25-IS &amp; Model 25-IS-1 Radiation detected Gamma (X ray) typically &lt; 18 count per&#xD;
      minute per milliroentgen/hr.&#xD;
&#xD;
      Beta response typically &lt; 0.10 milliroentgen/hr Display range For 25-IS: 0.01&#xD;
      milliroentgen/hr to 10 sievert/hr For 25-IS-1: 0.01 millisievert/hr to 10 sievert/hr Size.&#xD;
      7.6 x5.4x1.7 cm (H x W x thickness) Weight. 158.6 g. Including batteries Linearity. Reading&#xD;
      within 10% of true value within calibration range&#xD;
&#xD;
      Analysis of data Data were expressed as mean and standard deviation and analysed by using&#xD;
      SPSS version 18.0. Categorical data were compared by using Chi-square test; while, the&#xD;
      recorded data using dependent t-test. A p &lt; 0.05 was considered statistically significant&#xD;
      difference at 95% confidence interval.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2015</start_date>
  <completion_date type="Actual">December 2016</completion_date>
  <primary_completion_date type="Actual">December 2016</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Amount of radiative difference</measure>
    <time_frame>up to 1 year</time_frame>
    <description>The amount of radiative difference on the outside of the shirt-covered box and the glass shield as compared to the inside.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">222</enrollment>
  <condition>Cholangiopancreatography, Endoscopic Retrograde</condition>
  <condition>Occupational Exposure</condition>
  <condition>Radiation Injuries</condition>
  <arm_group>
    <arm_group_label>PDSa (Pocket radiation dosimeter a)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A co-researcher reset and prepared 4 pocket dosimeters (PDS) and labelled as PDSa1, PDSa2, PDSb1 and PDSb2.&#xD;
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</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PDSb (Pocket radiation dosimeter b)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.&#xD;
Position B was 160 cm. above the floor.</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>PDSa</intervention_name>
    <description>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).</description>
    <arm_group_label>PDSa (Pocket radiation dosimeter a)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>PDSb</intervention_name>
    <description>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).</description>
    <arm_group_label>PDSb (Pocket radiation dosimeter b)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The patient who underwent ERCP&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  None&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Department of Anesthesiology Siriraj Hospital</last_name>
    <role>Study Director</role>
    <affiliation>Department of Anesthesia, Faculty of Medicine Siriraj Hospital, Mahidol University</affiliation>
  </overall_official>
  <reference>
    <citation>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.</citation>
    <PMID>20537638</PMID>
  </reference>
  <reference>
    <citation>Ismail 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.</citation>
    <PMID>19922509</PMID>
  </reference>
  <reference>
    <citation>Miller 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.</citation>
    <PMID>557989</PMID>
  </reference>
  <reference>
    <citation>Markou 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.</citation>
    <PMID>17450255</PMID>
  </reference>
  <reference>
    <citation>Daas 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.</citation>
    <PMID>20567530</PMID>
  </reference>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>November 27, 2016</study_first_submitted>
  <study_first_submitted_qc>December 4, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 7, 2016</study_first_posted>
  <last_update_submitted>December 4, 2016</last_update_submitted>
  <last_update_submitted_qc>December 4, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 7, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Siriraj Hospital</investigator_affiliation>
    <investigator_full_name>Phawan Suton</investigator_full_name>
    <investigator_title>Nurse Anesthetist</investigator_title>
  </responsible_party>
  <keyword>Anesthesiology( H02.403.066 )</keyword>
  <keyword>Radiation Protection( N06.850.810.425)</keyword>
  <keyword>Cholangiopancreatography, Endoscopic Retrograde(D002760 )</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Radiation Injuries</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02985164
org study id: 270/2558(EC2)
nct id: NCT02985164
lead sponsor: 
has dmc: Yes
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.
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.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Amount of radiative difference
time frame: up to 1 year
description: The amount of radiative difference on the outside of the shirt-covered box and the glass shield as compared to the inside.
arm group label: PDSa (Pocket radiation dosimeter a)
arm group type: Experimental
description: 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
arm group label: PDSb (Pocket radiation dosimeter b)
arm group type: Experimental
description: 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.
intervention type: Radiation
intervention name: PDSa
description: 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).
arm group label: PDSa (Pocket radiation dosimeter a)
intervention type: Radiation
intervention name: PDSb
description: 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).
arm group label: PDSb (Pocket radiation dosimeter b)
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Department of Anesthesiology Siriraj Hospital
role: Study Director
affiliation: Department of Anesthesia, Faculty of Medicine Siriraj Hospital, Mahidol University
citation: 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.
PMID: 20537638
citation: Ismail 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.
PMID: 19922509
citation: Miller 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.
PMID: 557989
citation: Markou 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.
PMID: 17450255
citation: Daas 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.
PMID: 20567530
responsible party type: Principal Investigator
investigator affiliation: Siriraj Hospital
investigator full name: Phawan Suton
investigator title: Nurse Anesthetist
mesh term: Radiation Injuries
sharing ipd: Yes