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

September 20, 2011
June 11, 2014
July 2011
January 2016   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01438385 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Interventional Endoscopy Database for Pancreatico-biliary, Gastrointestinal and Esophageal Disorders
Endoscopic Retrograde Cholangiopancreatography, Endoscopic Ultrasound and Interventional Endoscopy in Pancreatico-biliary, Gastrointestinal and Esophageal Disorders

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.

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.

Observational
Time Perspective: Prospective
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Not Provided
Non-Probability Sample

Any subject that underwent Interventional Endoscopy for Pancreatico-biliary, Gastrointestinal or Esophageal disorders.

  • 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
Not Provided
Interventional Endoscopy
Any group that went Interventional Endoscopy procedures.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
15000
July 2016
January 2016   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Michel Kahaleh, MD 646-962-4000 mik9071@med.cornell.edu
Contact: Monica R Gaidhane, MD, MPH 646-962-4796 mog2012@med.cornell.edu
United States
 
NCT01438385
1104011642
No
Michel Kahaleh, Weill Medical College of Cornell University
Weill Medical College of Cornell University
Not Provided
Principal Investigator: Michel Kahaleh, MD Weill Medical College of Cornell University
Weill Medical College of Cornell University
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP