Recruiting

Observational Study

Sponsor:

Weill Medical College of Cornell University

Code:

NCT01438385

Conditions

Ampullary Cancer

Duodenal Cancer

Bile Duct Cancer

Bile Duct Disorders

Gallstones

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Interventional Endoscopy

Study Details

Brief summary:

Our institution performs therapeutic ERCP (Endoscopic retrograde cholangiopancreatography ), Endoscopic Ultrasound (EUS) and Interventional Endoscopy in around 1000 patients a year. Procedures such as biliary and/or pancreatic sphincterotomy, stents placement (metallic or plastic) and removal for revision, cysts and pseudocysts drainage are conducted in patients suffering from pancreatico-biliary disorders, gastrointestinal disorders and esophageal disorders. The investigators would like to assess prospectively the efficacy and safety of these routine procedures to permit identification of technical details about the procedures or other factors which might be associated with outcome or results. Assessment of these details would help us with problem identification and recommendations to improve health outcomes and quality of life in these patients.

Conditions

Ampullary Cancer

Duodenal Cancer

Bile Duct Cancer

Bile Duct Disorders

Gallstones

Study ID

NCT01438385

Start date

Jul, 2011

Status verified date

Feb, 2017

Completion date

Dec 30, 2017

Anticipated

Primary completion date

Dec 30, 2017

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Any subject that underwent Interventional Endoscopy for Pancreatico-biliary, Gastrointestinal or Esophageal disorders.
  • Above the age of 18 years

Exclusion Criteria:

  • Any group that did not undergo Interventional Endoscopy for Pancreatico-biliary, Gastrointestinal or Esophageal disorders.
  • Below the age of 18 years

Study Design

Enrollment

12000 participants

Anticipated

Interventions and Outcome Measures

Arms

Interventional Endoscopy

Any group that went Interventional Endoscopy procedures.

Interventions

Interventional Endoscopy

Advanced imaging endoscopic or therapeutic endoscopy

Primary outcome measure

  • Establishing a database that contains all Interventional Endoscopies [ Time Frame: 5 years ]

Central Contacts and Locations

Central contacts

Michel Kahaleh, MD

646-962-4000mik9071@med.cornell.edu

Monica R Gaidhane, MD, MPH

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

Locations

Weill Cornell Medical College of Cornell University

Recruiting

New York, New York, United States, 10021

Contacts

Michel Kahaleh, MD

646-962-4000mik9071@med.cornell.edu

Monica R Gaidhane, MD, MPH

646 962 4797mog2012@med.cornell.edu

Principal Investigator:

Michel Kahaleh, MD

More Information

Sponsor

Weill Medical College of Cornell University

Last update posted

Feb 20, 2017

Last verified

Feb, 2017

Keywords

  • Pancreatico-biliary
  • Biliary
  • Bile Duct
  • Gastrointestinal disorder
  • Esophageal disorder

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Weill Medical College of Cornell University on 2017-02-20.