Clinical trial NCT01438385: Interventional Endoscopy Database for Pancreatico-biliary, Gastrointestinal and Esophageal Disorders
Official title: Endoscopic Retrograde Cholangiopancreatography, Endoscopic Ultrasound and Interventional Endoscopy in Pancreatico-biliary, Gastrointestinal and Esophageal Disorders
Study type: OBSERVATIONAL
Overall status: UNKNOWN
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
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
First posted: 2011-09-22
Enrollment: 12000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any subject that underwent Interventional Endoscopy for Pancreatico-biliary, Gastrointestinal or Esophageal disorders.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Establishing a database that contains all Interventional Endoscopies
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Cornell Medical College of Cornell University
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Michel Kahaleh, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.