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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Weill Medical College of Cornell University
Sponsor:
Information provided by (Responsible Party):
Michel Kahaleh, Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT01438385
First received: September 20, 2011
Last updated: June 11, 2014
Last verified: June 2014
  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
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

Study Type: Observational
Study Design: 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 Weill Medical College of Cornell University:

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


Estimated Enrollment: 15000
Study Start Date: July 2011
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
Interventional Endoscopy
Any group that went Interventional Endoscopy procedures.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: September 20, 2011
Last Updated: June 11, 2014
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Barrett Esophagus
Bile Duct Diseases
Neoplasms
Cholangitis
Gallstones
Cholelithiasis
Cholecystolithiasis
Colorectal Neoplasms
Duodenal Neoplasms
Esophageal Diseases
Esophageal Neoplasms
Jaundice
Jaundice, Obstructive
Stomach Neoplasms
Pancreatic Diseases
Pancreatic Neoplasms
Pancreatic Pseudocyst
Pancreatitis
Pancreatitis, Chronic
Cholangiocarcinoma
Cholestasis
Choledocholithiasis
Bile Duct Neoplasms
Constriction, Pathologic
Digestive System Abnormalities
Digestive System Diseases
Gastrointestinal Diseases
Biliary Tract Diseases
Gallbladder Diseases
Calculi

ClinicalTrials.gov processed this record on July 24, 2014