Radiation Exposure of ERCP Personnel at Different Standing Locations and Different Patient Positions.

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.

Study Overview

• Status: Completed
• Conditions: Occupational Radiation Exposure
• Intervention / Treatment: Radiation: Automatic beam adjustment function

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 Type: Interventional
• Enrollment (Actual): 55
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Indicated for ERCP

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Left lateral decubitus; 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.	Radiation: Automatic beam adjustment function; The fluoroscopy system has an automatic beam adjustment function to maintain a good quality of image output.
Experimental: Prone; 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.	Radiation: Automatic beam adjustment function; The fluoroscopy system has an automatic beam adjustment function to maintain a good quality of image output.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effective Radiation Dose	The effective radiation which represents equivalent dose to eye lens of each personnel were compared between 2 groups.	Immediate after procedure

Collaborators and Investigators

• Sponsor: Chulalongkorn University
• Investigators: Principal Investigator: Rungsun Rerknimitr, MD, FRCP, Chulalongkorn University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2016
• Primary Completion (Actual): October 1, 2016
• Study Completion (Actual): November 1, 2016

Study Registration Dates

• First Submitted: June 1, 2016
• First Submitted That Met QC Criteria: June 1, 2016
• First Posted (Estimate): June 7, 2016

Study Record Updates

• Last Update Posted (Actual): May 30, 2017
• Last Update Submitted That Met QC Criteria: April 25, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: ERCP; radiation exposure; prone; left lateral decubitus
• Other Study ID Numbers: PA-E-RAD002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No