Los Angeles Prospective GI Biliary and EUS Series
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|ClinicalTrials.gov Identifier: NCT02196935|
Recruitment Status : Recruiting
First Posted : July 22, 2014
Last Update Posted : June 15, 2022
Endoscopic retrograde cholangiopancreatography and endoscopic ultrasound are increasingly being used to manage complex disease of the bile duct, pancreas and cancer. Gastroenterology patients at the Los Angeles County Hospital presents a unique and diverse patient population.
Our aim is to study the biochemical, radiographic, and clinical predictors of bile duct stones. Exploratory aims include the study of the management of cholangitis, bile leaks, GI cancer diagnosis and management, and the management of pancreaticobiliary problems in the underserved.
All patients managed by EUS or ERCP at the LA County & USC University Hospitals will be enrolled in the databaseThe timing, clinical presentation, and objective details of patient presentation are recorded prospectively. Additionally the results of the subsequent ERCP and EUS procedures. Subsequent, clinical course and pathology will also be recorded.
|Condition or disease||Intervention/treatment|
|Biliary Disease Pancreatitis Gastrointestinal Neoplasms||Other: clinical course|
|Study Type :||Observational|
|Estimated Enrollment :||2500 participants|
|Official Title:||Prospective Evaluation of Pancreatic, Biliary, and Gastrointestinal Neoplasia by Endoscopic Retrograde Cholangiopancreatography (ERCP) and Endoscopic Ultrasound (EUS)|
|Study Start Date :||September 2010|
|Estimated Primary Completion Date :||December 2025|
|Estimated Study Completion Date :||December 2025|
All patients who undergo ERCP and EUS for clinical indications will undergo a detailed prospective assessment of clinical course.
Other: clinical course
Detailed presentation including labs, demographics, imaging of those who undergo ERCP/EUS with be prospectively recorded. Details of procedure including sedation strategy and success will be collected. Results of procedure including final pathology results with be recorded.
- Successful ERCP or EUS [ Time Frame: 1 year ]Completed ERCP or EUS in which objectives of procedure were met.Unsuccessful ERCP will be classified as secondary to technical (such as failed cannulation or stent placement) versus sedation failure in which patient could not be sedated.
- Bile Duct Stone [ Time Frame: 1 year ]Definite bile duct stone confirmed by cholangiogram
- Length of Hospitalization [ Time Frame: 1 year ]Duration of hospitalization from presentation to the emergency department to discharge or death.
- Definitive Diagnosis [ Time Frame: 1 year ]Pathologic diagnosis which enables definitive treatment plan, answer
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02196935
|Contact: James Buxbaum, MDfirstname.lastname@example.org|
|Contact: Maria Trujilloemail@example.com|
|United States, California|
|Los Angeles County Hospital||Recruiting|
|Los Angeles, California, United States, 91030|
|Contact: Maria Trujillo 323-409-6939 firstname.lastname@example.org|
|Principal Investigator: James Buxbaum, MD|
|Principal Investigator:||James L Buxbaum, MD||University of Southern California School of Medicine|