Comparison Of Radiation Exposure To Patients During ERCPs Performed By Endoscopists Trained In Judicious Use Of Fluoroscopy With Those Without Formal Training
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 1,000
- Locations
- 1
- Primary Endpoint
- Radiation exposure as assessed by fluoroscopy time
Overview
Brief Summary
Purpose: To compare the radiation exposure in patients during Endoscopic retrograde cholangiopancreatography (ERCP) done by Endoscopists formally trained in judicious use of fluoroscopy versus ERCPs done by Endoscopists without such formal training.
Research design: This is an observational study to compare radiation exposure in patients during ERCPs based on formal training.
Procedures to be used: None Risks and potential benefits There are no risks associated with this study as it is a retrospective chart review. Potential benefits include the knowledge gained from this study which may be of help to patients in the future.
Importance of knowledge that may reasonably be expected to result The knowledge gained from this study may be of help to provide new insights and develop newer guidelines for radiation use in the future.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to 100 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Any indications for undergoing an ERCP. If a patient undergoes more than one ERCP then it shall be reported as such, as multiple data points.
- •Only those ERCP cases will be included that have been exposed to fluoroscopy (X-ray radiation).
- •Adult populations will be included, all races and belonging to any gender will be included in the study.
Exclusion Criteria
- •Patients who didn't receive ERCP
- •Those in whom the biliary or pancreatic ducts are not cannulated and therefore who do not receive any fluoroscopy
- •Pregnant women
- •Patient population less than 18 years of age
Outcomes
Primary Outcomes
Radiation exposure as assessed by fluoroscopy time
Time Frame: at the time of ERCP
Radiation exposure of patients who undergo ERCP (Endoscopic Retrograde Cholangio Pancreatography) will be assessed by fluoroscopy time, which is indicated by the device used for ERCP. Fluoroscopy time at the time of ERCP will be recorded at the end of the procedure and is documented by the endoscopy technician.
Radiation exposure as assessed by total emittance
Time Frame: at the time of ERCP
Radiation exposure of patients who undergo ERCP (Endoscopic Retrograde Cholangio Pancreatography) will be assessed by total emittance, which is indicated by the device used for ERCP. Total emittance at the time of ERCP will be recorded at the end of the procedure and is documented by the endoscopy technician.
Secondary Outcomes
No secondary outcomes reported
Investigators
Nirav C Thosani
Assistant Professor
The University of Texas Health Science Center, Houston