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

• Sponsor: Weill Medical College of Cornell University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01438385
• Collaborator: (none)
• Enrollment: 12,000
• Location: 1
• Duration (Months): 78
• Patients Per Site Per Month: 153.9

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
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

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.

Study Design

• Study Type: Observational
• Anticipated Enrollment: 12000 participants
• Observational Model: Other
• Time Perspective: Prospective
• Official Title: Endoscopic Retrograde Cholangiopancreatography, Endoscopic Ultrasound and Interventional Endoscopy in Pancreatico-biliary, Gastrointestinal and Esophageal Disorders
• Study Start Date: Jul 1, 2011
• Anticipated Primary Completion Date: Dec 30, 2017
• Anticipated Study Completion Date: Dec 30, 2017

Arms and Interventions

Arm	Intervention/Treatment
Interventional Endoscopy Any group that went Interventional Endoscopy procedures.	Procedure: Interventional Endoscopy; Advanced imaging endoscopic or therapeutic endoscopy; Other Names: Advanced Endoscopy

Outcome Measures

Primary Outcome Measures

1. Establishing a database that contains all Interventional Endoscopies [5 years]

   Collection of procedure specific details of all Interventional Endoscopies

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Weill Cornell Medical College of Cornell University	New York	New York	United States	10021

Sponsors and Collaborators

• Weill Medical College of Cornell University

Investigators

• Principal Investigator: Michel Kahaleh, MD, Weill Medical College of Cornell University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Michel Kahaleh, Chief, Advanced Endoscopy, Weill Medical College of Cornell University
• ClinicalTrials.gov Identifier: NCT01438385
• Other Study ID Numbers: 1104011642
• First Posted: Sep 22, 2011
• Last Update Posted: Feb 20, 2017
• Last Verified: Feb 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Michel Kahaleh, Chief, Advanced Endoscopy, Weill Medical College of Cornell University: Pancreatico-biliary; Biliary; Bile Duct; Gastrointestinal disorder; Esophageal disorder
• Additional relevant MeSH terms: Cholangiocarcinoma; Barrett Esophagus; Bile Duct Neoplasms; Pancreatic Pseudocyst; Duodenal Neoplasms; Pancreatitis; Cholangitis; Pancreatitis, Chronic; Gallstones; Choledocholithiasis; Esophageal Diseases; Bile Duct Diseases; Pancreatic Diseases; Disease; Jaundice; Jaundice, Obstructive

Study Results

No Results Posted as of Feb 20, 2017