Los Angeles Prospective GI Biliary and EUS Series

NCT02196935 | Unknown

• 1 other identifier: HS-10-00369
• Study Type: observational
• Target: 2,500
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Successful ERCP or EUS

  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.

  1 year

Secondary Outcomes (3)

• Bile Duct Stone

  1 year

• Length of Hospitalization

  1 year

• Definitive Diagnosis

  1 year

Study Arms (1)

ERCP/EUS

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

Other: clinical course

Interventions

clinical course OTHER

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.

ERCP/EUS

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients undergoing ERCP or EUS for clinical indications

You may qualify if:

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

You may not qualify if:

• None of the patients will be excluded.

Sponsors & Collaborators

• University of Southern California: lead

Study Sites (1)

Los Angeles County Hospital

Los Angeles, California, 91030, United States

RECRUITING

Related Publications (6)

• Singh S, Purohit T, Aoun E, Patel Y, Carleton N, Mitre M, Morrissey S, Dhawan M, Thakkar S. Comparison of the outcomes of endoscopic ultrasound based on community hospital versus tertiary academic center settings. Dig Dis Sci. 2014 Aug;59(8):1925-30. doi: 10.1007/s10620-014-3075-9. Epub 2014 Feb 27.

  PMID: 24573718 BACKGROUND

• Mehta PP, Vargo JJ, Dumot JA, Parsi MA, Lopez R, Zuccaro G. Does anesthesiologist-directed sedation for ERCP improve deep cannulation and complication rates? Dig Dis Sci. 2011 Jul;56(7):2185-90. doi: 10.1007/s10620-011-1568-3. Epub 2011 Jan 28.

  PMID: 21274625 BACKGROUND

• Vargo JJ, Zuccaro G Jr, Dumot JA, Shermock KM, Morrow JB, Conwell DL, Trolli PA, Maurer WG. Gastroenterologist-administered propofol versus meperidine and midazolam for advanced upper endoscopy: a prospective, randomized trial. Gastroenterology. 2002 Jul;123(1):8-16. doi: 10.1053/gast.2002.34232.

  PMID: 12105827 BACKGROUND

• Khashab MA, Tariq A, Tariq U, Kim K, Ponor L, Lennon AM, Canto MI, Gurakar A, Yu Q, Dunbar K, Hutfless S, Kalloo AN, Singh VK. Delayed and unsuccessful endoscopic retrograde cholangiopancreatography are associated with worse outcomes in patients with acute cholangitis. Clin Gastroenterol Hepatol. 2012 Oct;10(10):1157-61. doi: 10.1016/j.cgh.2012.03.029. Epub 2012 Apr 13.

  PMID: 22507875 BACKGROUND

• Navaneethan U, Gutierrez NG, Jegadeesan R, Venkatesh PG, Butt M, Sanaka MR, Vargo JJ, Parsi MA. Delay in performing ERCP and adverse events increase the 30-day readmission risk in patients with acute cholangitis. Gastrointest Endosc. 2013 Jul;78(1):81-90. doi: 10.1016/j.gie.2013.02.003. Epub 2013 Mar 23.

  PMID: 23528654 BACKGROUND

• Barkun AN, Barkun JS, Fried GM, Ghitulescu G, Steinmetz O, Pham C, Meakins JL, Goresky CA. Useful predictors of bile duct stones in patients undergoing laparoscopic cholecystectomy. McGill Gallstone Treatment Group. Ann Surg. 1994 Jul;220(1):32-9. doi: 10.1097/00000658-199407000-00006.

  PMID: 7517657 BACKGROUND

MeSH Terms

Conditions

Gallbladder Diseases; Pancreatitis; Gastrointestinal Neoplasms; Cholangitis; Choledocholithiasis

Condition Hierarchy (Ancestors)

Biliary Tract Diseases; Digestive System Diseases; Pancreatic Diseases; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Gastrointestinal Diseases; Bile Duct Diseases; Common Bile Duct Diseases; Cholelithiasis

Study Officials

• James L Buxbaum, MD

  University of Southern California School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

James Buxbaum, MD

CONTACT

3234096939; jbuxbaum@usc.edu

Maria Trujillo

CONTACT

3234096939; mit@usc.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Endoscopy, Los Angeles County Hospital

Study Record Dates

• First Submitted: July 19, 2014
• First Posted: July 22, 2014
• Study Start: September 1, 2010
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: June 15, 2022

Record last verified: 2022-06

Locations

US (1)