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

NCT ID: NCT01438385

Last Updated: 2017-02-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

12000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-07-31

Study Completion Date

2017-12-30

Brief Summary

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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

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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

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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

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Interventional Endoscopy

Any group that went Interventional Endoscopy procedures.

Interventional Endoscopy

Intervention Type PROCEDURE

Advanced imaging endoscopic or therapeutic endoscopy

Interventions

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Interventional Endoscopy

Advanced imaging endoscopic or therapeutic endoscopy

Intervention Type PROCEDURE

Other Intervention Names

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Advanced Endoscopy

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Weill Medical College of Cornell University

OTHER

Sponsor Role lead

Responsible Party

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Michel Kahaleh

Chief, Advanced Endoscopy

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michel Kahaleh, MD

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Locations

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Weill Cornell Medical College of Cornell University

New York, New York, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Michel Kahaleh, MD

Role: CONTACT

646-962-4000

Monica R Gaidhane, MD, MPH

Role: CONTACT

646-962-4796

Facility Contacts

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Michel Kahaleh, MD

Role: primary

646-962-4000

Monica R Gaidhane, MD, MPH

Role: backup

646 962 4797

References

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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.

Reference Type DERIVED
PMID: 27237786 (View on PubMed)

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.

Reference Type DERIVED
PMID: 27059973 (View on PubMed)

Other Identifiers

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1104011642

Identifier Type: -

Identifier Source: org_study_id

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