Recruiting

Observational Study

Sponsor:

University of Southern California

Code:

NCT02196935

Conditions

Biliary Disease

Pancreatitis

Gastrointestinal Neoplasms

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

clinical course

Study Details

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.

Conditions

Biliary Disease

Pancreatitis

Gastrointestinal Neoplasms

Study ID

NCT02196935

Start date

Sep, 2010

Status verified date

Jun, 2022

Completion date

Dec, 2025

Anticipated

Primary completion date

Dec, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

2500 participants

Anticipated

Interventions and Outcome Measures

Arms

ERCP/EUS

All patients who undergo ERCP and EUS for clinical indications will undergo a detailed prospective assessment of clinical course.

Interventions

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 measure

  • Successful ERCP or EUS [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

James Buxbaum, MD

3234096939jbuxbaum@usc.edu

Maria Trujillo

3234096939mit@usc.edu

Locations

Los Angeles County Hospital

Recruiting

Los Angeles, California, United States, 91030

Contacts

Maria Trujillo

323-409-6939mit@usc.edu

Principal Investigator:

James Buxbaum, MD

More Information

Sponsor

University of Southern California

Last update posted

Jun 15, 2022

Last verified

Jun, 2022

Keywords

  • Cholangitis
  • Choledocholithiasis
  • Gastrointestinal Neoplasms
  • Medically underserved area
  • Anesthesia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Southern California on 2022-06-15.