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2015-11
2021-12
2025-12
1000
NCT03525353
The University of Texas Health Science Center, Houston
The University of Texas Health Science Center, Houston
OBSERVATIONAL
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
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.
N/A
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2016-01-04 | N/A | 2021-01-11 |
2018-05-02 | N/A | 2021-01-12 |
2018-05-15 | N/A | 2021-01 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
N/A
Allocation:
N/A
Interventional Model:
N/A
Masking:
N/A
Arms and Interventions
| Participant Group/Arm | 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
|
| : 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
|
| Primary Outcome Measures | 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 |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
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 |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
1
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
NPCF was founded on May 29, 2009 and is a 501(c)(3) organization. All donations are tax deductible.
The information and services provided by the National Pancreatic Cancer Foundation are for informational purposes only. The information and services are not intended to be substitutes for professional medical advice, diagnosis or treatment. The National Pancreatic Cancer Foundation does not recommend nor endorse any specific physicians, products or treatments even though they may be mentioned on this site.
