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Status unknownNCT01438385Updated Feb 20, 2017

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

An observational study in Ampullary Cancer, Duodenal Cancer and Bile Duct Cancer, sponsored by Weill Medical College of Cornell University. Status unknown at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-02-20.

Sponsored by Weill Medical College of Cornell University · Observational

The sponsor has not verified this record recently (last verified Feb 2017), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
12,000
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • 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
03

In context

Duodenal Neoplasms

51 studies on the registry are indexed under Duodenal Neoplasms; 14 are open to participants now.

This study's planned enrollment of 12,000 is above the median of 200 across 17 observational studies indexed under Duodenal Neoplasms.

Browse Duodenal Neoplasms studies →

Lead sponsor

Weill Medical College of Cornell University is the lead sponsor of 892 studies on the registry; 165 are open to participants now.

Of its 123 completed or terminated interventional studies of FDA-regulated products, 94 (76%) have results posted.

Browse Weill Medical College of Cornell University studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Any group that did not undergo Interventional Endoscopy for Pancreatico-biliary, Gastrointestinal or Esophageal disorders.
  • Below the age of 18 years
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
12,000 participants (estimated)
Patient registry
No

Groups and cohorts

  • Interventional Endoscopy

    Any group that went Interventional Endoscopy procedures.

    Procedure: Interventional Endoscopy

Interventions

  • ProcedureInterventional Endoscopy

    Advanced imaging endoscopic or therapeutic endoscopy

    Also known as: Advanced Endoscopy

06

What researchers measure

Primary outcomes

  1. Establishing a database that contains all Interventional Endoscopies

    Collection of procedure specific details of all Interventional Endoscopies

    Time frame: 5 years

07

Study locations

1 of 1 sites recruiting
  • Weill Cornell Medical College of Cornell University
    New York, New York 10021, United States
    Recruiting
08

References and documents

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. PubMed 27059973 ↗
  • 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. PubMed 27237786 ↗

Individual participant data

Plan to share: No — No IPD Sharing

09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jul 2011, a primary completion of Dec 2017 and a completion of Dec 2017. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 20, 2011
First posted
Sep 22, 2011
Start
Jul 2011
Primary completionEst.
Dec 30, 2017
CompletionEst.
Dec 30, 2017
Last update
Feb 20, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 20, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01438385
Lead sponsor
Weill Medical College of Cornell University
Responsible party
Michel Kahaleh (Chief, Advanced Endoscopy, Weill Medical College of Cornell University) — Principal investigator
First posted
Sep 22, 2011
Start date
Jul 2011
Primary completion
Dec 30, 2017 (estimated)
Completion
Dec 30, 2017 (estimated)
Last update
Feb 20, 2017

Study contacts

Michel Kahaleh, MD
Contact
mik9071@med.cornell.edu
646-962-4000
Monica R Gaidhane, MD, MPH
Contact
mog2012@med.cornell.edu
646-962-4796
Michel Kahaleh, MD
principal investigator · Weill Medical College of Cornell University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.

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