Clinical trial NCT02791659: Radiation Exposure of ERCP Personnel at Different Standing Locations and Different Patient Positions.
Official title: Radiation Exposure of ERCP Personnel at Different Standing Locations and Different Patient Positions (Prone and Left Lateral Decubitus)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Occupational Radiation Exposure
Keywords: radiation exposure
ERCP
prone
left lateral decubitus
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
First posted: 2016-06-07
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Effective Radiation Dose
timeFrame: Immediate after procedure
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Chulalongkorn University
name: Rungsun Rerknimitr, MD, FRCP
role: PRINCIPAL_INVESTIGATOR
References: