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OpenTrials
Completed

NCT Number: NCT02791659

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Automatic beam adjustment function

Radiation

The fluoroscopy system has an automatic beam adjustment function to maintain a good quality of image output.

Primary outcomes

  1. Effective Radiation Dose

    Time frame: Immediate after procedure

    The effective radiation which represents equivalent dose to eye lens of each personnel were compared between 2 groups.

Sponsors and collaborators

Lead sponsor

Chulalongkorn University

Other

Registry information

Official study title

Radiation Exposure of ERCP Personnel at Different Standing Locations and Different Patient Positions (Prone and Left Lateral Decubitus)

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jun 7, 2016
Registry last updated
May 30, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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