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

NCT ID: NCT02791659

Last Updated: 2017-05-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-31
• Study Completion Date: 2016-11-30

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.

Conditions

Occupational Radiation Exposure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Automatic beam adjustment function

Intervention Type: RADIATION

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

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.

Group Type: EXPERIMENTAL

Automatic beam adjustment function

Intervention Type: RADIATION

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

Interventions

Automatic beam adjustment function

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

Intervention Type: RADIATION

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chulalongkorn University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rungsun Rerknimitr, MD, FRCP

Role: PRINCIPAL_INVESTIGATOR

Chulalongkorn University

Other Identifiers

PA-E-RAD002

Identifier Type: -

Identifier Source: org_study_id