Radiation Exposure During Endoscopic Retrograde Cholangiopancreatography

December 4, 2016 updated by: Phawan Suton, Siriraj Hospital

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

222

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • The patient who underwent ERCP

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: PDSa (Pocket radiation dosimeter a)

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
Radiation: PDSa
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).
EXPERIMENTAL: PDSb (Pocket radiation dosimeter b)

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.
Radiation: PDSb
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
up to 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Siriraj Hospital

Investigators

  • Study Director: Department of Anesthesiology Siriraj Hospital, Department of Anesthesia, Faculty of Medicine Siriraj Hospital, Mahidol University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (ACTUAL)

December 1, 2016

Study Completion (ACTUAL)

December 1, 2016

Study Registration Dates

First Submitted

November 27, 2016

First Submitted That Met QC Criteria

December 4, 2016

First Posted (ESTIMATE)

December 7, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

December 7, 2016

Last Update Submitted That Met QC Criteria

December 4, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 270/2558(EC2)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Radiation Injuries

Clinical Trials on PDSa

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Guinea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe