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

Colorectal Cancer Clinical Trial

Official title:

Endoscopic Retrograde Cholangiopancreatography, Endoscopic Ultrasound and Interventional Endoscopy in Pancreatico-biliary, Gastrointestinal and Esophageal Disorders

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01438385
• Other study ID #: 1104011642
• Status: Recruiting
• Phase: N/A
• First received: September 20, 2011
• Last updated: February 16, 2017
• Start date: July 2011
• Est. completion date: December 30, 2017

Study information

• Verified date: February 2017
• Source: Weill Medical College of Cornell University
• Contact: Michel Kahaleh, MD
• Phone: 646-962-4000
• Email: mik9071[@]med.cornell.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12000
• Est. completion date: December 30, 2017
• Est. primary completion date: December 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute and Chronic Pancreatitis
• Ampullary Cancer
• Barrett Esophagus
• Barrett's Esophagus
• Bile Duct Cancer
• Bile Duct Diseases
• Bile Duct Disorders
• Bile Duct Neoplasms
• Bile Leak
• Biliary and Pancreatic Stones
• Biliary Strictures
• Cholangiocarcinoma
• Cholangitis
• Choledocholithiasis
• Colorectal Cancer
• Colorectal Neoplasms
• Disease
• Duodenal Cancer
• Duodenal Neoplasms
• Esophageal Cancer
• Esophageal Diseases
• Esophageal Neoplasms
• Gallstones
• Gastric Malignancies
• Jaundice
• Jaundice, Obstructive
• Obstructive Jaundice
• Pancreatic Cancer
• Pancreatic Diseases
• Pancreatic Disorders (Noncancerous)
• Pancreatic Divisum
• Pancreatic Neoplasms
• Pancreatic Pseudocyst
• Pancreatic Pseudocysts
• Pancreatitis
• Pancreatitis, Chronic
• Pediatric Gastroenterology
• Recurrent Pancreatitis
• Stomach Neoplasms

Intervention

Procedure:
• Interventional Endoscopy
Advanced imaging endoscopic or therapeutic endoscopy

Locations

Country	Name	City	State
United States	Weill Cornell Medical College of Cornell University	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Establishing a database that contains all Interventional Endoscopies	Collection of procedure specific details of all Interventional Endoscopies	5 years