Recruiting

T-EUS

Sponsor:

Weill Medical College of Cornell University

Code:

NCT01522573

Conditions

Cholangiocarcinoma

Pancreatic Cancer

Bile Duct Cancer

Biliary Stricture

Biliary Obstruction

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

EUS guided ERCP

Study Details

Brief summary:

The purpose of this registry is to record information and evaluate the impact of Endoscopic Ultrasound (EUS) Guided Endoscopic retrograde cholangiopancreatography (ERCP) on the management of pancreatico-biliary disorders. The registry will evaluate efficacy, safety and technical success of the Endoscopic Ultrasound (EUS)Guided Endoscopic retrograde cholangiopancreatography (ERCP) procedures. The safety and efficacy of various EUS-Guided ERCP procedures have been assessed in a series of studies.

This multi-center registry has been initiated:

  • To document the impact of EUS-Guided ERCP procedures on the management of pancreatico-biliary disorders including malignancies.
  • To assess the clinical and technical success rates of EUS-Guided ERCPs for diagnostic or therapeutic procedures.

Design is retrospective and prospective registry study.

Procedures that will be captured include:

1. EUS-Coils placement
2. EUS Glue injection
3. EUS-Fiducial placement
4. EUS-Neurolysis
5. EUS-Stent placement
6. EUS-alcohol injection
7. EUS-fluid collection, abscess or cavity drainage
8. EUS guided ductal drainage
9. EUS-guided Ablation
10. EUS-guided anastomosis 11. EUS Guided ERCP for gallbladder, pancreatic duct or biliary duct drainage

Conditions

Cholangiocarcinoma

Pancreatic Cancer

Bile Duct Cancer

Biliary Stricture

Biliary Obstruction

Study ID

NCT01522573

Start date

Nov, 2011

Status verified date

Feb, 2017

Completion date

Dec 30, 2018

Anticipated

Primary completion date

Dec 30, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Any patient who has undergone EUS-guided ERCP (Endoscopic Retrograde Cholangiopancreatography)for diagnosis or treatment of a pancreatico-biliary disorder.
  • Above 18 years of age.

Exclusion Criteria:

  • Any subject who has not undergone Endoscopic Ultrasound (EUS) guided Endoscopic retrograde cholangiopancreatography (ERCP).
  • Below 18 years of age.

Study Design

Enrollment

1000 participants

Anticipated

Interventions and Outcome Measures

Arms

EUS guided ERCP procedure group

Subjects who will undergo Endoscopic Ultrasound (EUS) guided Endoscopic retrograde cholangiopancreatography (ERCP) procedures for their pancreatico-biliary conditions.

Interventions

EUS guided ERCP

Endoscopic ultrasound guided (EUS) endoscopic retrograde cholangiopancreatography (ERCP)

Primary outcome measure

  • Safety [ Time Frame: 3 years ]

Central Contacts and Locations

Locations

Weill Cornell Medical College

Recruiting

New York, New York, United States, 10021

Contacts

Michel Kahaleh, MD

646-962-4797mkahaleh@gmail.com

Monica Gaidhane, MPH

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

Principal Investigator:

Michel Kahaleh, MD

More Information

Sponsor

Weill Medical College of Cornell University

Last update posted

Feb 20, 2017

Last verified

Feb, 2017

Keywords

  • Cholangiocarcinoma
  • Pancreatic Cancer
  • Bile Duct Cancer
  • Biliary Stricture
  • Biliary obstruction
  • Stent obstruction
  • Proximal duct stricture
  • Distal duct stricture
  • Ampullary Cancer
  • Biliary sphincter stenosis
  • Impacted stones
  • Chronic pancreatitis
  • Peri-ampullary diverticula
  • Altered anatomy
  • Endoscopic ultrasound
  • Endoscopic Retrograde Cholangiopancreatography
  • Multicenter

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Weill Medical College of Cornell University on 2017-02-20.