Trial record 49 of 70 for:    gastroenterology | Recruiting | Exclude Unknown | United States

Los Angeles Prospective GI Biliary and EUS Series

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by University of Southern California
Sponsor:
Information provided by (Responsible Party):
James Buxbaum, University of Southern California
ClinicalTrials.gov Identifier:
NCT02196935
First received: July 19, 2014
Last updated: NA
Last verified: July 2014
History: No changes posted
  Purpose

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 Intervention
Biliary Disease
Pancreatitis
Gastrointestinal Neoplasms
Other: clinical course

Study Type: Observational
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by University of Southern California:

Primary Outcome Measures:
  • Successful ERCP or EUS [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    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:
  • Bile Duct Stone [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Definite bile duct stone confirmed by cholangiogram

  • Length of Hospitalization [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Duration of hospitalization from presentation to the emergency department to discharge or death.

  • Definitive Diagnosis [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Pathologic diagnosis which enables definitive treatment plan, answer


Estimated Enrollment: 2500
Study Start Date: September 2010
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02196935

Contacts
Contact: James Buxbaum, MD 3234095371 jbuxbaum@usc.edu
Contact: Maria Trujillo 3234096939 mit@usc.edu

Locations
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
Principal Investigator: James L Buxbaum, MD University of Southern California School of Medicine
  More Information

Publications:

Responsible Party: James Buxbaum, Director of Endoscopy, Los Angeles County Hospital, University of Southern California
ClinicalTrials.gov Identifier: NCT02196935     History of Changes
Other Study ID Numbers: HS-10-00369
Study First Received: July 19, 2014
Last Updated: July 19, 2014
Health Authority: United States: Data and Safety Monitoring Board

Keywords provided by University of Southern California:
Cholangitis
Choledocholithiasis
Gastrointestinal Neoplasms
Medically underserved area
Anesthesia

Additional relevant MeSH terms:
Digestive System Neoplasms
Gallbladder Diseases
Gastrointestinal Neoplasms
Neoplasms
Pancreatitis
Biliary Tract Diseases
Digestive System Diseases
Gastrointestinal Diseases
Neoplasms by Site
Pancreatic Diseases

ClinicalTrials.gov processed this record on October 29, 2014