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

Recruiting

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

• Registration Number: NCT03525353
• Lead Sponsor: The University of Texas Health Science Center, Houston

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-11
• Study First Submitted: 2016-01-04
• Study First Submitted QC: 2018-05-02
• Study First Posted: 2018-05-15
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-11
• Last Update Posted: 2021-01-12
• Primary Completion: 2021-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients undergoing ERCP by formally trained Endoscopists	Endoscopic retrograde cholangiopancreatography - No Intervention have been used other than standard of care	Patients who undergo ERCP (Endoscopic Retrograde Cholangio Pancreatography) performed by Endoscopists who are trained on minimum use of fluoroscopy.
Patients undergoing ERCP by Endoscopists not formally trained	Endoscopic retrograde cholangiopancreatography - No Intervention have been used other than standard of care	Patients who undergo ERCP (Endoscopic Retrograde Cholangio Pancreatography) performed by Endoscopists who have not received formal training on minimum use of fluoroscopy.

Primary Outcome Measures

Name	Time	Method
Radiation exposure as assessed by fluoroscopy time	at the time of ERCP	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.
Radiation exposure as assessed by total emittance	at the time of ERCP	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.

Trial Locations

Locations (1)

Memorial Hermann Hospital; 🇺🇸 Houston, Texas, United States