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Interventional Endoscopy Database for Pancreatico-biliary, Gastrointestinal and Esophageal Disorders

This study is currently recruiting participants.
Verified February 2017 by Michel Kahaleh, Weill Medical College of Cornell University
Sponsor:
ClinicalTrials.gov Identifier:
NCT01438385
First Posted: September 22, 2011
Last Update Posted: February 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Michel Kahaleh, Weill Medical College of Cornell University
  Purpose
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.

Condition Intervention
Ampullary Cancer Duodenal Cancer Bile Duct Cancer Bile Duct Disorders Gallstones Obstructive Jaundice Pancreatic Disorders (Noncancerous) Colorectal Cancer Esophageal Cancer Barrett's Esophagus Gastric Malignancies Pancreatic Cancer Pediatric Gastroenterology Cholangiocarcinoma Pancreatic Pseudocysts Acute and Chronic Pancreatitis Recurrent Pancreatitis Cholangitis Bile Leak Biliary Strictures Pancreatic Divisum Biliary and Pancreatic Stones Choledocholithiasis Procedure: Interventional Endoscopy

Study Type: Observational
Study Design: Observational Model: Other
Time Perspective: Prospective
Official Title: Endoscopic Retrograde Cholangiopancreatography, Endoscopic Ultrasound and Interventional Endoscopy in Pancreatico-biliary, Gastrointestinal and Esophageal Disorders

Resource links provided by NLM:


Further study details as provided by Michel Kahaleh, Weill Medical College of Cornell University:

Primary Outcome Measures:
  • Establishing a database that contains all Interventional Endoscopies [ Time Frame: 5 years ]
    Collection of procedure specific details of all Interventional Endoscopies


Estimated Enrollment: 12000
Study Start Date: July 2011
Estimated Study Completion Date: December 30, 2017
Estimated Primary Completion Date: December 30, 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Interventional Endoscopy
Any group that went Interventional Endoscopy procedures.
Procedure: Interventional Endoscopy
Advanced imaging endoscopic or therapeutic endoscopy
Other Name: Advanced Endoscopy

Detailed Description:
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Any subject that underwent Interventional Endoscopy for Pancreatico-biliary, Gastrointestinal or Esophageal disorders.
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01438385


Contacts
Contact: Michel Kahaleh, MD 646-962-4000 mik9071@med.cornell.edu
Contact: Monica R Gaidhane, MD, MPH 646-962-4796 mog2012@med.cornell.edu

Locations
United States, New York
Weill Cornell Medical College of Cornell University Recruiting
New York, New York, United States, 10021
Contact: Michel Kahaleh, MD    646-962-4000    mik9071@med.cornell.edu   
Contact: Monica R Gaidhane, MD, MPH    646 962 4797    mog2012@med.cornell.edu   
Principal Investigator: Michel Kahaleh, MD         
Sponsors and Collaborators
Weill Medical College of Cornell University
Investigators
Principal Investigator: Michel Kahaleh, MD Weill Medical College of Cornell University
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Michel Kahaleh, Chief, Advanced Endoscopy, Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT01438385     History of Changes
Other Study ID Numbers: 1104011642
First Submitted: September 20, 2011
First Posted: September 22, 2011
Last Update Posted: February 20, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No IPD Sharing

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Michel Kahaleh, Weill Medical College of Cornell University:
Pancreatico-biliary
Biliary
Bile Duct
Gastrointestinal disorder
Esophageal disorder

Additional relevant MeSH terms:
Disease
Colorectal Neoplasms
Pancreatic Neoplasms
Esophageal Neoplasms
Pancreatitis
Cholangiocarcinoma
Barrett Esophagus
Cholangitis
Bile Duct Neoplasms
Pancreatitis, Chronic
Jaundice
Gallstones
Choledocholithiasis
Jaundice, Obstructive
Pancreatic Pseudocyst
Esophageal Diseases
Duodenal Neoplasms
Pancreatic Diseases
Stomach Neoplasms
Bile Duct Diseases
Pathologic Processes
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases