Radiation Exposure of ERCP Personnel at Different Standing Locations and Different Patient Positions.
1 other identifier
interventional
55
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2016
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 1, 2016
CompletedFirst Posted
Study publicly available on registry
June 7, 2016
CompletedStudy Start
First participant enrolled
July 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2016
CompletedResults Posted
Study results publicly available
March 22, 2017
CompletedMay 30, 2017
April 1, 2017
3 months
June 1, 2016
February 1, 2017
April 25, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Effective Radiation Dose
The effective radiation which represents equivalent dose to eye lens of each personnel were compared between 2 groups.
Immediate after procedure
Study Arms (2)
Left lateral decubitus
ACTIVE COMPARATORIn 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
EXPERIMENTALIn 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.
Interventions
The fluoroscopy system has an automatic beam adjustment function to maintain a good quality of image output.
Eligibility Criteria
You may qualify if:
- Indicated for ERCP
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Results Point of Contact
- Title
- Phonthep Angsuwatcharakon, MD
- Organization
- Gastroenterology endoscopy center
Study Officials
- PRINCIPAL INVESTIGATOR
Rungsun Rerknimitr, MD, FRCP
Chulalongkorn University
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 1, 2016
First Posted
June 7, 2016
Study Start
July 1, 2016
Primary Completion
October 1, 2016
Study Completion
November 1, 2016
Last Updated
May 30, 2017
Results First Posted
March 22, 2017
Record last verified: 2017-04
Data Sharing
- IPD Sharing
- Will not share