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

The University of Texas System (UT)

Status: Enrolling

Conditions: Pancreatic Cancer

Treatments: Other: Endoscopic retrograde cholangiopancreatography - No Intervention have been used other than standard of care

Study type: Observational

Funder types: Other

Identifiers

NCT03525353

HSC-MS-15-0019

Details and patient eligibility

About

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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

1,000 participants in 2 patient groups

Patients undergoing ERCP by formally trained Endoscopists

Description:

Patients who undergo ERCP (Endoscopic Retrograde Cholangio Pancreatography) performed by Endoscopists who are trained on minimum use of fluoroscopy.

Treatment:

Other: Endoscopic retrograde cholangiopancreatography - No Intervention have been used other than standard of care

Patients undergoing ERCP by Endoscopists not formally trained

Description:

Patients who undergo ERCP (Endoscopic Retrograde Cholangio Pancreatography) performed by Endoscopists who have not received formal training on minimum use of fluoroscopy.

Treatment:

Other: Endoscopic retrograde cholangiopancreatography - No Intervention have been used other than standard of care