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Los Angeles Prospective GI Biliary and EUS Series

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02196935
Recruitment Status : Recruiting
First Posted : July 22, 2014
Last Update Posted : June 15, 2022
Sponsor:
Information provided by (Responsible Party):
James Buxbaum, University of Southern California

Brief Summary:

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

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Study Type : Observational
Estimated Enrollment : 2500 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
ERCP/EUS
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Bile Duct Stone [ Time Frame: 1 year ]
    Definite bile duct stone confirmed by cholangiogram

  2. Length of Hospitalization [ Time Frame: 1 year ]
    Duration of hospitalization from presentation to the emergency department to discharge or death.

  3. Definitive Diagnosis [ Time Frame: 1 year ]
    Pathologic diagnosis which enables definitive treatment plan, answer



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients undergoing ERCP or EUS for clinical indications
Criteria

Inclusion Criteria:

  • All patients undergoing EUS or ERCP at LAC, UH, and Norris Cancer Hospitals as standard of clinical care will be enrolled.

Exclusion Criteria:

  • None of the patients will be excluded.

Information from the National Library of Medicine

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


Contacts
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Contact: James Buxbaum, MD 3234096939 jbuxbaum@usc.edu
Contact: Maria Trujillo 3234096939 mit@usc.edu

Locations
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United States, California
Los Angeles County Hospital Recruiting
Los Angeles, California, United States, 91030
Contact: Maria Trujillo    323-409-6939    mit@usc.edu   
Principal Investigator: James Buxbaum, MD         
Sponsors and Collaborators
University of Southern California
Investigators
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Principal Investigator: James L Buxbaum, MD University of Southern California School of Medicine
Publications:

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Responsible Party: James Buxbaum, Director of Endoscopy, Los Angeles County Hospital, University of Southern California
ClinicalTrials.gov Identifier: NCT02196935    
Other Study ID Numbers: HS-10-00369
First Posted: July 22, 2014    Key Record Dates
Last Update Posted: June 15, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by James Buxbaum, University of Southern California:
Cholangitis
Choledocholithiasis
Gastrointestinal Neoplasms
Medically underserved area
Anesthesia
Additional relevant MeSH terms:
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Gastrointestinal Neoplasms
Digestive System Neoplasms
Pancreatitis
Gallbladder Diseases
Neoplasms
Pancreatic Diseases
Digestive System Diseases
Neoplasms by Site
Gastrointestinal Diseases
Biliary Tract Diseases