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

NCT ID: NCT03525353

Last Updated: 2021-01-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-11-30

Study Completion Date

2025-12-31

Brief Summary

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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

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Conditions

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Pancreatic Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

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

Intervention Type OTHER

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.

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

Intervention Type OTHER

No intervention has been used and this is an observational study

Interventions

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

No intervention has been used and this is an observational study

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The University of Texas Health Science Center, Houston

OTHER

Sponsor Role lead

Responsible Party

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Nirav C Thosani

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nirav Thosani, MD MHA

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

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Memorial Hermann Hospital

Houston, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Prithvi Patil, MS

Role: CONTACT

(713) 500-6654

Priyanka Priyanka, BAMS, MPH

Role: CONTACT

7135006457

Facility Contacts

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Prithvi Patil, MS

Role: primary

713-500-6654

Other Identifiers

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HSC-MS-15-0019

Identifier Type: -

Identifier Source: org_study_id

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