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

February 16, 2017 updated by: Michel Kahaleh, Weill Medical College of Cornell University

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

12000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10021
        • Recruiting
        • Weill Cornell Medical College of Cornell University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Establishing a database that contains all Interventional Endoscopies
Time Frame: 5 years
Collection of procedure specific details of all Interventional Endoscopies
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Weill Medical College of Cornell University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (Anticipated)

December 30, 2017

Study Completion (Anticipated)

December 30, 2017

Study Registration Dates

First Submitted

September 20, 2011

First Submitted That Met QC Criteria

September 21, 2011

First Posted (Estimate)

September 22, 2011

Study Record Updates

Last Update Posted (Actual)

February 20, 2017

Last Update Submitted That Met QC Criteria

February 16, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1104011642

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No IPD Sharing

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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