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

NCT01438385 | Unknown

• 1 other identifier: 1104011642
• Study Type: observational
• Target: 12,000
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Pancreatico-biliary; Biliary; Bile Duct; Gastrointestinal disorder; Esophageal disorder

Outcome Measures

Primary Outcomes (1)

• Establishing a database that contains all Interventional Endoscopies

  Collection of procedure specific details of all Interventional Endoscopies

  5 years

Study Arms (1)

Interventional Endoscopy

Any group that went Interventional Endoscopy procedures.

Procedure: Interventional Endoscopy

Interventions

Interventional Endoscopy PROCEDURE

Advanced imaging endoscopic or therapeutic endoscopy

Also known as: Advanced Endoscopy

Interventional Endoscopy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Any subject that underwent Interventional Endoscopy for Pancreatico-biliary, Gastrointestinal or Esophageal disorders.
• Above the age of 18 years

You may not qualify if:

• Any group that did not undergo Interventional Endoscopy for Pancreatico-biliary, Gastrointestinal or Esophageal disorders.
• Below the age of 18 years

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Study Sites (1)

Weill Cornell Medical College of Cornell University

New York, New York, 10021, United States

RECRUITING

Related Publications (2)

• 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.

  PMID: 27237786 DERIVED

• 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.

  PMID: 27059973 DERIVED

MeSH Terms

Conditions

Duodenal Neoplasms; Bile Duct Neoplasms; Bile Duct Diseases; Gallstones; Jaundice, Obstructive; Pancreatic Diseases; Colorectal Neoplasms; Esophageal Neoplasms; Barrett Esophagus; Pancreatic Neoplasms; Cholangiocarcinoma; Pancreatic Pseudocyst; Pancreatitis, Chronic; Cholangitis; Pancreas Divisum; Choledocholithiasis; Gastrointestinal Diseases; Esophageal Diseases

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Duodenal Diseases; Intestinal Diseases; Biliary Tract Neoplasms; Biliary Tract Diseases; Cholelithiasis; Cholecystolithiasis; Gallbladder Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Jaundice; Hyperbilirubinemia; Pathologic Processes; Skin Manifestations; Signs and Symptoms; Colonic Diseases; Rectal Diseases; Head and Neck Neoplasms; Precancerous Conditions; Endocrine Gland Neoplasms; Endocrine System Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Pancreatic Cyst; Cysts; Pancreatitis; Chronic Disease; Disease Attributes; Digestive System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Common Bile Duct Diseases

Study Officials

• Michel Kahaleh, MD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michel Kahaleh, MD

CONTACT

646-962-4000; mik9071@med.cornell.edu

Monica R Gaidhane, MD, MPH

CONTACT

646-962-4796; mog2012@med.cornell.edu

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Advanced Endoscopy

Study Record Dates

• First Submitted: September 20, 2011
• First Posted: September 22, 2011
• Study Start: July 1, 2011
• Primary Completion: December 30, 2017
• Study Completion: December 30, 2017
• Last Updated: February 20, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)