Clinical trial NCT03525353: Comparison Of Radiation Exposure To Patients During Endoscopic Retrograde Cholangiopancreatography (ERCP) Performed By Endoscopists Trained In Judicious Use Of Fluoroscopy With Those Without Formal Training
Official title: Comparison Of Radiation Exposure To Patients During ERCPs Performed By Endoscopists Trained In Judicious Use Of Fluoroscopy With Those Without Formal Training
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pancreatic Cancer
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2018-05-15
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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).

Those in whom the biliary or pancreatic ducts are not cannulated and therefore who do not receive any fluoroscopy will be excluded.

Adult populations will be included, all races and belonging to any gender will be included in the study.

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.


Eligibility 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

Primary outcomes:
measure: Radiation exposure as assessed by fluoroscopy time
timeFrame: at the time of ERCP
measure: Radiation exposure as assessed by total emittance
timeFrame: at the time of ERCP
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Memorial Hermann Hospital
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Nirav Thosani, MD MHA
role: PRINCIPAL_INVESTIGATOR
References: