Biliary DiseaseNCT02196935
Los Angeles Prospective GI Biliary and EUS Series
An observational study of Biliary Disease and Pancreatitis, run by University of Southern California at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Biliary Disease, Pancreatitis, Gastrointestinal Neoplasms
- What is being tested?
- clinical course
- How many people
- 2,500 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2010to Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients undergoing ERCP or EUS for clinical indications
Who may be able to join
- All patients undergoing EUS or ERCP at LAC, UH, and Norris Cancer Hospitals as standard of clinical care will be enrolled.
Who cannot join
- None of the patients will be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Los Angeles County Hospital
Los Angeles, California, 91030
Maria Trujillo, 323-409-6939, mit@usc.edu
James Buxbaum, MD
About this study
Official title: Prospective Evaluation of Pancreatic, Biliary, and Gastrointestinal Neoplasia by Endoscopic Retrograde Cholangiopancreatography (ERCP) and Endoscopic Ultrasound (EUS)
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.
Read the detailed description
AIMS A) Characterize unusual disease and pathologic presentations which require endoscopic treatment in a large safety net hospital B) To study the impact of EUS and ERCP on the management of these patients. C) Analyze how EUS and ERCP results correlate with other radiographic methods including conventional ultrasound and computed tomography (CT) D) Compare role of EUS and ERCP in a safety net versus tertiary care center
II) BACKGROUND Endscopic Ultrasound (EUS) which consists of an endoscope containing a high frequency transducer, has become standard of care to evaluate gastrointestinal cancer as well as diseases included chronic pancreatitis. EUS with fine needle aspiration (FNA) has been demonstrated to be the least invasive and most effective means to acquire tissue in a number of situations included pancreas cancer and maligant lymph nodes. Endoscopic Retrograde Cholangiopancreatography (ERCP) is a therapeutic procedure used to manage choledocholithiasis, bile duct obstruction and occasional pancreatic ductal problems. Its diagostic uses are now more limited with the advent of EUS and cross sectional radiographic studies including CT and magnetic resonance cholangiopancreatography (MRCP).
A number of leading ERCP/EUS groups including those at the University of Alabama (Birmingham, Alabama), the Cleveland Clinic (Cleveland Ohio) and the Mayo Clinic (Rochester, Minnesota) have developed ERCP/EUS databases which have led to important insight about the role of these procedure and the diseases they are used to manage. However, these groups and indeed almost the entire world literature regarding EUS and ERCP focuses on America, Western European, and Japanese populations.
The goal of this database will be to study the impact of EUS and ERCP on an underserved population at LAC. The prevalence of certain diseases including cholangitis, large bile duct stones, and gastric cancer are markedly higher at our institution than in other western facilities presenting a unique opportunity to report how they are treated as part of standard management.
IIIA) DESIGN AND METHODOLOGY
- ALL PROCEDURES ARE DONE STRICTLY AS STANDARD OF CARE.
- Detailed collection sheets containing no PHI but with detailed information about laboratories, symptoms, radiographic tests, time of presentation and procedure detals are prospectively completed for patients undergoing EUS or ERCP by the Gastroenterology service at the USC Hospitals. The resulting pathology and clinical course are collected on these anonymized forms.
- The information in the extraction sheets is entered into a database stripped of all personal health identifiers.
IIIB) PLANNED DATA COLLECTION
- The aim of this project will be to develop a prospective database of EUS/ERCP cases at USC.
- For both ERCP and EUS cases detailed information regarding the presentation of the patients will be noted. Specifically, which radiographic and biochemical markers and clinical symptoms are of interest.
- For EUS the outcomes include the confirmation by biopsies and imaging of the underlying pathology.
- For ERCP the outcomes are procedural success and more specifically bile duct stone confirmation and removal, treatment of cholangitis, treatment of leaks biliary, and decompression of obstruction. Success of anesthesia strategy is an aim of the collection.
- For potential quality of care assessment procedure complications and success of anesthesia strategy are a priori areas of study
IV) STATISTICAL CONSIDERATIONS As this study involves creation of a database of standard of care management of patients by EUS and ERCP primarily descriptive statistics will be used in future studies. If individual groups are compared (ie those with positive versus atypical fine needle aspiration) chi squared versus t statistic will be used for analysis depending on distribution..
- Conditions
- Biliary Disease, Pancreatitis, Gastrointestinal Neoplasms
- Being tested
- clinical course
- Keywords
- Cholangitis, Choledocholithiasis, Gastrointestinal Neoplasms, Medically underserved area, Anesthesia
- Medical subject headings
- Gallbladder Diseases, Pancreatitis, Gastrointestinal Neoplasms, Cholangitis, Choledocholithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clinical courseOther
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.
| Study group | Role | What they receive |
|---|---|---|
| ERCP/EUS | All patients who undergo ERCP and EUS for clinical indications will undergo a detailed prospective assessment of clinical course. Receives: Other: clinical course |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (3)
Bile Duct Stone
Definite bile duct stone confirmed by cholangiogram
Measured: 1 year
Length of Hospitalization
Duration of hospitalization from presentation to the emergency department to discharge or death.
Measured: 1 year
Definitive Diagnosis
Pathologic diagnosis which enables definitive treatment plan, answer
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2014 (estimated)
- Study startSep 2010
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Biliary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James Buxbaum, University of Southern California
- Investigators
- James L Buxbaum, MD, Principal investigator, University of Southern California School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02196935
- Sponsor's protocol ID
- HS-10-00369
- Status last verified
- Jun 2022
- First submitted
- 19 Jul 2014
- Last updated
- 15 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 24573718Mehta 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.
PubMed 21274625Vargo 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.
PubMed 12105827Khashab 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.
PubMed 22507875Navaneethan 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.
PubMed 23528654Barkun 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.
PubMed 7517657
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of Pancreatic, Biliary, and Gastrointestinal Neoplasia by Endoscopic Retrograde Cholangiopancreatography (ERCP) and Endoscopic Ultrasound (EUS)
- ClinicalTrials.gov ID
- NCT02196935
- Acronym / sponsor ID
- HS-10-00369
- Conditions
- Biliary Disease, Pancreatitis, Gastrointestinal Neoplasms
- Keywords
- Cholangitis, Choledocholithiasis, Gastrointestinal Neoplasms, Medically underserved area, Anesthesia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 22 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
AIMS A) Characterize unusual disease and pathologic presentations which require endoscopic treatment in a large safety net hospital B) To study the impact of EUS and ERCP on the management of these patients. C) Analyze how EUS and ERCP results correlate with other radiographic methods including conventional ultrasound and computed tomography (CT) D) Compare role of EUS and ERCP in a safety net versus tertiary care center
II) BACKGROUND Endscopic Ultrasound (EUS) which consists of an endoscope containing a high frequency transducer, has become standard of care to evaluate gastrointestinal cancer as well as diseases included chronic pancreatitis. EUS with fine needle aspiration (FNA) has been demonstrated to be the least invasive and most effective means to acquire tissue in a number of situations included pancreas cancer and maligant lymph nodes. Endoscopic Retrograde Cholangiopancreatography (ERCP) is a therapeutic procedure used to manage choledocholithiasis, bile duct obstruction and occasional pancreatic ductal problems. Its diagostic uses are now more limited with the advent of EUS and cross sectional radiographic studies including CT and magnetic resonance cholangiopancreatography (MRCP).
A number of leading ERCP/EUS groups including those at the University of Alabama (Birmingham, Alabama), the Cleveland Clinic (Cleveland Ohio) and the Mayo Clinic (Rochester, Minnesota) have developed ERCP/EUS databases which have led to important insight about the role of these procedure and the diseases they are used to manage. However, these groups and indeed almost the entire world literature regarding EUS and ERCP focuses on America, Western European, and Japanese populations.
The goal of this database will be to study the impact of EUS and ERCP on an underserved population at LAC. The prevalence of certain diseases including cholangitis, large bile duct stones, and gastric cancer are markedly higher at our institution than in other western facilities presenting a unique opportunity to report how they are treated as part of standard management.
IIIA) DESIGN AND METHODOLOGY
- ALL PROCEDURES ARE DONE STRICTLY AS STANDARD OF CARE.
- Detailed collection sheets containing no PHI but with detailed information about laboratories, symptoms, radiographic tests, time of presentation and procedure detals are prospectively completed for patients undergoing EUS or ERCP by the Gastroenterology service at the USC Hospitals. The resulting pathology and clinical course are collected on these anonymized forms.
- The information in the extraction sheets is entered into a database stripped of all personal health identifiers.
IIIB) PLANNED DATA COLLECTION
- The aim of this project will be to develop a prospective database of EUS/ERCP cases at USC.
- For both ERCP and EUS cases detailed information regarding the presentation of the patients will be noted. Specifically, which radiographic and biochemical markers and clinical symptoms are of interest.
- For EUS the outcomes include the confirmation by biopsies and imaging of the underlying pathology.
- For ERCP the outcomes are procedural success and more specifically bile duct stone confirmation and removal, treatment of cholangitis, treatment of leaks biliary, and decompression of obstruction. Success of anesthesia strategy is an aim of the collection.
- For potential quality of care assessment procedure complications and success of anesthesia strategy are a priori areas of study
IV) STATISTICAL CONSIDERATIONS As this study involves creation of a database of standard of care management of patients by EUS and ERCP primarily descriptive statistics will be used in future studies. If individual groups are compared (ie those with positive versus atypical fine needle aspiration) chi squared versus t statistic will be used for analysis depending on distribution..
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ERCP/EUS | – | Other: clinical courseAll patients who undergo ERCP and EUS for clinical indications will undergo a detailed prospective assessment of clinical course. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients undergoing ERCP or EUS for clinical indications
Key inclusion criteria (1 listed)
- All patients undergoing EUS or ERCP at LAC, UH, and Norris Cancer Hospitals as standard of clinical care will be enrolled.
Key exclusion criteria (1 listed)
- None of the patients will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| clinical courseDetailed 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. | Other | ERCP/EUS |
Primary outcome
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.
3 secondary outcomes
Bile Duct Stone
Time frame: 1 year
Length of Hospitalization
Time frame: 1 year
Definitive Diagnosis
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2022.
- Background: PubMed 24573718Singh 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.
- Background: PubMed 21274625Mehta 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.
- Background: PubMed 12105827Vargo 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.
- Background: PubMed 22507875Khashab 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.
- Background: PubMed 23528654Navaneethan 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.
- Background: PubMed 7517657Barkun 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James L Buxbaum, MD principal investigator
University of Southern California School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Biliary Disease and Pancreatitis, run by University of Southern California at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact James Buxbaum, MD (3234096939, jbuxbaum@usc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful ERCP or EUS (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02196935, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2022.