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.

Study Overview

• Status: Unknown
• Conditions: Colorectal Cancer; Pancreatic Cancer; Esophageal Cancer; Cholangiocarcinoma; Bile Duct Cancer; Cholangitis; Barrett's Esophagus; Gallstones; Choledocholithiasis; Bile Leak; Obstructive Jaundice; Duodenal Cancer; Pancreatic Pseudocysts; Ampullary Cancer; Biliary Strictures; Recurrent Pancreatitis; Bile Duct Disorders; Pancreatic Disorders (Noncancerous); Gastric Malignancies; Pediatric Gastroenterology; Acute and Chronic Pancreatitis; Pancreatic Divisum; Biliary and Pancreatic Stones
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 12000

Contacts and Locations

Study Locations

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

Participation Criteria

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

How is the study designed?

Number of groups / cohorts

1

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	Collection of procedure specific details of all Interventional Endoscopies	5 years

Collaborators and Investigators

• Sponsor: Weill Medical College of Cornell University

Publications and helpful links

General Publications

• Desai AP, Tyberg A, Kedia P, Smith MS, Martinez G, Zamarripa F, Schneider Y, Bertani H, Frazzoni M, Casas F, Khanna LG, Lambroza A, Kumta NA, Khan A, Sharaiha RZ, Salgado S, Gaidhane M, Sethi A, Kahaleh M. Optical coherence tomography (OCT) prior to peroral endoscopic myotomy (POEM) reduces procedural time and bleeding: a multicenter international collaborative study. Surg Endosc. 2016 Nov;30(11):5126-5133. doi: 10.1007/s00464-016-4859-0. Epub 2016 Apr 8.
• Tyberg A, Desai AP, Kumta NA, Brown E, Gaidhane M, Sharaiha RZ, Kahaleh M. EUS-guided biliary drainage after failed ERCP: a novel algorithm individualized based on patient anatomy. Gastrointest Endosc. 2016 Dec;84(6):941-946. doi: 10.1016/j.gie.2016.05.035. Epub 2016 May 26.

Study record dates

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: Biliary; Gastrointestinal disorder; Bile Duct; Pancreatico-biliary; Esophageal disorder
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Cysts; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Pathological Conditions, Anatomical; Intestinal Neoplasms; Duodenal Diseases; Skin Manifestations; Precancerous Conditions; Gallbladder Diseases; Biliary Tract Diseases; Common Bile Duct Diseases; Calculi; Cholelithiasis; Cholecystolithiasis; Biliary Tract Neoplasms; Hyperbilirubinemia; Pancreatic Cyst; Disease; Cholangiocarcinoma; Pancreatitis; Cholangitis; Barrett Esophagus; Pancreatitis, Chronic; Gallstones; Pancreatic Diseases; Choledocholithiasis; Jaundice; Bile Duct Diseases; Bile Duct Neoplasms; Esophageal Diseases; Jaundice, Obstructive; Pancreatic Pseudocyst; Duodenal Neoplasms
• 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