Advanced Imaging Registry for Diagnosing Pancreatico-biliary Disorders

NCT02166086 | Unknown

• 1 other identifier: 1111012020
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this registry is to record information and evaluate the impact of advanced imaging techniques on the management of pancreatico-biliary disorders. The registry will evaluate diagnostic performance and overall clinical management impacted by advanced imaging techniques.

Conditions

Diagnosis of a Pancreaticobiliary Disorder

Outcome Measures

Primary Outcomes (1)

• Efficacy Profile

  Documentation of accuracy, sensitivity, specificity, positive predictive value, negative predictive value based on final diagnosis variable analyses.

  1 year

Secondary Outcomes (1)

• Survival duration

  1 year or more

Other Outcomes (2)

• Efficacy

  1 year

• Safety Profile

  30 days

Study Arms (1)

Endoscopic imaging

Any patient who has undergone advanced imaging procedures for diagnosis and/or treatment of a pancreatico-biliary disorder.

Procedure: Endoscopy

Interventions

Endoscopy PROCEDURE

Endoscopy involving advanced imaging techniques

Endoscopic imaging

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Any patient who has undergone advanced imaging procedures for diagnosis and/or treatment of a pancreatico-biliary disorder.

You may qualify if:

• Any patient who has undergone advanced imaging procedures for diagnosis and/or treatment of a pancreatico-biliary disorder.
• Above 18 years of age.

You may not qualify if:

• Any patient who has not undergone advanced imaging techniques for pancreatico-biliary disorders.
• Below 18 years of age.

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Study Sites (1)

Weill Cornell Medical College

New York, New York, 10021, United States

RECRUITING

Related Publications (3)

• Tyberg A, Xu MM, Gaidhane M, Kahaleh M. Second generation optical coherence tomography: Preliminary experience in pancreatic and biliary strictures. Dig Liver Dis. 2018 Nov;50(11):1214-1217. doi: 10.1016/j.dld.2018.05.019. Epub 2018 Jun 8.

  PMID: 29937365 DERIVED

• Karia K, Waxman I, Konda VJ, Gress FG, Sethi A, Siddiqui UD, Sharaiha RZ, Kedia P, Jamal-Kabani A, Gaidhane M, Kahaleh M. Needle-based confocal endomicroscopy for pancreatic cysts: the current agreement in interpretation. Gastrointest Endosc. 2016 May;83(5):924-7. doi: 10.1016/j.gie.2015.08.080. Epub 2015 Sep 14.

  PMID: 26382051 DERIVED

• Karia K, Jamal-Kabani A, Gaidhane M, Tyberg A, Sharaiha RZ, Kahaleh M. Probe-Based Confocal Endomicroscopy in Primary Sclerosing Cholangitis: Not All Inflammatory Strictures Are the Same. Dig Dis Sci. 2016 Jan;61(1):283-6. doi: 10.1007/s10620-015-3827-1. Epub 2015 Aug 2.

  PMID: 26233552 DERIVED

MeSH Terms

Interventions

Endoscopy

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Michel Kahaleh, MD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michel Kahaleh, MD

CONTACT

646-962-4797; mik9071@med.cornell.edu

Monica R Gaidhane, MPH

CONTACT

646-962-4796; mog2012@med.cornell.edu

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Endoscopy

Study Record Dates

• First Submitted: June 10, 2014
• First Posted: June 18, 2014
• Study Start: September 1, 2011
• Primary Completion: December 1, 2018
• Study Completion: December 30, 2018
• Last Updated: February 20, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)