search
Back to results

Radiation Exposure During Endoscopic Retrograde Cholangiopancreatography

Primary Purpose

Cholangiopancreatography, Endoscopic Retrograde, Occupational Exposure, Radiation Injuries

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
PDSa
PDSb
Sponsored by
Siriraj Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cholangiopancreatography, Endoscopic Retrograde focused on measuring Anesthesiology( H02.403.066 ), Radiation Protection( N06.850.810.425), Cholangiopancreatography, Endoscopic Retrograde(D002760 )

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • The patient who underwent ERCP

Exclusion Criteria:

  • None

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    PDSa (Pocket radiation dosimeter a)

    PDSb (Pocket radiation dosimeter b)

    Arm 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

    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.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    November 27, 2016
    Last Updated
    December 4, 2016
    Sponsor
    Siriraj Hospital
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02985164
    Brief Title
    Radiation Exposure During Endoscopic Retrograde Cholangiopancreatography
    Official Title
    Radiation Exposure Affecting Anaesthesia Personnel During Endoscopic Retrograde Cholangiopancreatography
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2015 (undefined)
    Primary Completion Date
    December 2016 (Actual)
    Study Completion Date
    December 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Siriraj Hospital

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief 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. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cholangiopancreatography, Endoscopic Retrograde, Occupational Exposure, Radiation Injuries
    Keywords
    Anesthesiology( H02.403.066 ), Radiation Protection( N06.850.810.425), Cholangiopancreatography, Endoscopic Retrograde(D002760 )

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    222 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    PDSa (Pocket radiation dosimeter a)
    Arm Type
    Experimental
    Arm 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 Title
    PDSb (Pocket radiation dosimeter b)
    Arm Type
    Experimental
    Arm 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(s)
    PDSa
    Intervention 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).
    Intervention Type
    Radiation
    Intervention Name(s)
    PDSb
    Intervention 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).
    Primary Outcome Measure Information:
    Title
    Amount of radiative difference
    Description
    The amount of radiative difference on the outside of the shirt-covered box and the glass shield as compared to the inside.
    Time Frame
    up to 1 year

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: The patient who underwent ERCP Exclusion Criteria: None
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Department of Anesthesiology Siriraj Hospital
    Organizational Affiliation
    Department of Anesthesia, Faculty of Medicine Siriraj Hospital, Mahidol University
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    Citations:
    PubMed Identifier
    20537638
    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.
    Results Reference
    background
    PubMed Identifier
    19922509
    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.
    Results Reference
    background
    PubMed Identifier
    557989
    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.
    Results Reference
    background
    PubMed Identifier
    17450255
    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.
    Results Reference
    background
    PubMed Identifier
    20567530
    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.
    Results Reference
    background

    Learn more about this trial

    Radiation Exposure During Endoscopic Retrograde Cholangiopancreatography

    We'll reach out to this number within 24 hrs