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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01438385
Other study ID # 1104011642
Secondary ID
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
Health authority
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

Study Design


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
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