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

Pancreatic Cancer Clinical Trial

Official title:

Comparison Of Radiation Exposure To Patients During ERCPs Performed By Endoscopists Trained In Judicious Use Of Fluoroscopy With Those Without Formal Training

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03525353
• Other study ID #: HSC-MS-15-0019
• Status: Recruiting
• Start date: November 2015
• Est. completion date: December 2025

Study information

• Verified date: January 2021
• Source: The University of Texas Health Science Center, Houston
• Contact: Prithvi Patil, MS
• Phone: (713) 500-6654
• Email: prithvi.b.patil[@]uth.tmc.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 2025
• Est. primary completion date: December 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Pancreatic Cancer

Intervention

Other:
• Endoscopic retrograde cholangiopancreatography - No Intervention have been used other than standard of care
No intervention has been used and this is an observational study

Locations

Country	Name	City	State
United States	Memorial Hermann Hospital	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Radiation exposure as assessed by fluoroscopy time	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.	at the time of ERCP
Primary	Radiation exposure as assessed by total emittance	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.	at the time of ERCP