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

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

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 Overview

• Status: Recruiting
• Conditions: Pancreatic Cancer
• Intervention / Treatment: Other: Endoscopic retrograde cholangiopancreatography - No Intervention have been used other than standard of care

• Study Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

• Study Contact: Name: Prithvi Patil, MS; Phone Number: (713) 500-6654; Email: prithvi.b.patil@uth.tmc.edu
• Study Contact Backup: Name: Priyanka Priyanka, BAMS, MPH; Phone Number: 7135006457; Email: priyanka.priyanka@uth.tmc.edu

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77054
      • Recruiting
      • Memorial Hermann Hospital
      • Contact: Prithvi Patil, MS; Phone Number: 713-500-6654; Email: prithvi.b.patil@uth.tmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients undergoing ERCP by formally trained Endoscopists; Patients who undergo ERCP (Endoscopic Retrograde Cholangio Pancreatography) performed by Endoscopists who are trained on minimum use of fluoroscopy.	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
Patients undergoing ERCP by Endoscopists not formally trained; Patients who undergo ERCP (Endoscopic Retrograde Cholangio Pancreatography) performed by Endoscopists who have not received formal training on minimum use of fluoroscopy.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Investigators: Principal Investigator: Nirav Thosani, MD MHA, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start: November 1, 2015
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): December 1, 2025

Study Registration Dates

• First Submitted: January 4, 2016
• First Submitted That Met QC Criteria: May 2, 2018
• First Posted (Actual): May 15, 2018

Study Record Updates

• Last Update Posted (Actual): January 12, 2021
• Last Update Submitted That Met QC Criteria: January 11, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: HSC-MS-15-0019