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

Not Applicable

Completed

• Conditions: Occupational Radiation Exposure
• Interventions: Radiation: Automatic beam adjustment function

• Registration Number: NCT02791659
• Lead Sponsor: Chulalongkorn University

Brief Summary

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.

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 Timeline

• Study First Submitted: 2016-06-01
• Study First Submitted QC: 2016-06-01
• Study First Posted: 2016-06-07
• Study Start: 2016-07
• Primary Completion: 2016-10
• Study Completion: 2016-11
• Results First Submitted: 2017-02-01
• Results First Submitted QC: 2017-02-01
• Results First Posted: 2017-03-22
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-25
• Last Update Posted: 2017-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Left lateral decubitus	Automatic beam adjustment function	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.
Prone	Automatic beam adjustment function	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.

Primary Outcome Measures

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