Comparing radiation exposure during ERCP based on endoscopist training
Comparison Of Radiation Exposure To Patients During ERCPs Performed By Endoscopists Trained In Judicious Use Of Fluoroscopy With Those Without Formal Training
This study looks at how much radiation patients get during a specific procedure called ERCP, comparing those done by trained doctors to those done by doctors without formal training.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | The University of Texas Health Science Center, Houston Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT03525353 on ClinicalTrials.gov |
What this trial studies
This observational study aims to compare the radiation exposure experienced by patients undergoing Endoscopic Retrograde Cholangiopancreatography (ERCP) performed by endoscopists trained in the judicious use of fluoroscopy versus those without formal training. The study will analyze data from ERCP cases that involved fluoroscopy, focusing on adult patients of all races and genders. By reviewing patient charts retrospectively, the study seeks to gather insights that could inform future guidelines on radiation use during these procedures.
Who should consider this trial
Good fit: Ideal candidates for this study are adult patients who require an ERCP and have been exposed to fluoroscopy during the procedure.
Not a fit: Patients who do not undergo ERCP or those whose ducts are not cannulated, resulting in no fluoroscopy exposure, will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved guidelines for minimizing radiation exposure during ERCP, enhancing patient safety.
How similar studies have performed: While this study's specific approach is observational and may not have been extensively tested, similar studies have shown the importance of training in reducing radiation exposure in medical procedures.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Houston, Texas
- Memorial Hermann Hospital — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Nirav Thosani, MD MHA — The University of Texas Health Science Center, Houston
- Study coordinator: Prithvi Patil, MS
- Email: prithvi.b.patil@uth.tmc.edu
- Phone: (713) 500-6654
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.