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Endoscopic Ultrasound (EUS)-Guided Endoscopic Retrograde Cholangiopancreatography (ERCP) in the Management of Pancreatico-biliary Disorders: A Multicenter Registry.

18 Years
Open (Enrolling)
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

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Trial Information

Endoscopic Ultrasound (EUS)-Guided Endoscopic Retrograde Cholangiopancreatography (ERCP) in the Management of Pancreatico-biliary Disorders: A Multicenter Registry.

Endoscopic Ultrasound (EUS) Guided Endoscopic retrograde cholangiopancreatography (ERCP)
has become a therapeutic intervention for the management of biliary obstruction or
pancreatic strictures related to chronic pancreatitis or other diseases. Successful biliary
or pancreatic cannulation can be achieved in 90 to 97%. Failure to obtain biliary access can
be related to operator experience, peri-ampullary diverticula, prior surgery (e.g., Billroth
II anatomy), tumor involvement of the ampulla, biliary sphincter stenosis and impacted
stones. In experienced hands, pancreatic duct cannulation fails in less than 10% of cases.
This is primarily related to surgically altered anatomy or inflammation. Referral to a
tertiary care center , percutaneous intrahepatic cholangiography (PTC) for biliary
decompression , and surgical intervention are typically offered after a failed ERCP.
Percutaneous intrahepatic cholangiography with subsequent percutaneous or endoscopic
drainage has a morbidity of up to 32%. Surgery can also be associated with significant
morbidity and mortality.

Endoscopic ultrasound (EUS) allows detailed imaging of the regional anatomy by approximating
the frequency transducer to the region of interest. With the evolution of linear array and
the ability to direct a needle within the field of interest, the therapeutic potential of
EUS has reached new levels beyond fine needle aspiration (FNA), celiac plexus blocks and
drainage of cystic lesions. The biliary and pancreatic systems, being in close proximity to
the gastric or duodenal lumen, are a logical target for EUS in cases not accessible by ERCP.
EUS-assisted cholangiopancreatography was described a decade ago. In order to validate these
procedures and broaden its use beyond tertiary centers, it is crucial to understand its
efficacy and success rate. The objective of the study is to evaluate retrospectively and
prospectively the efficacy and safety of EUS-Guided ERCP procedures for the diagnosis and
treatment of pancreatico-biliary disorders.

The purpose of this registry is to record information and evaluate the impact of EUS-Guided
ERCP on the management of pancreatico-biliary disorders. The registry will evaluate
efficacy, safety and technical success of the EUS-Guided ERCP procedures.

The involvement of multi-international sites is crucial- as the advanced endoscopists
outside US are attempting similar complex EUS-Guided ERCPs for complicated
pancreatico-biliary cases as their counterparts in US. However, because of the non-existence
of a registry, these cases are often reported as isolated case series with remarkable
technical similarities to case series in other countries.

The registry hopes to combine all such comparable cases and collect enough relevant data for
statistical analyses.

Inclusion Criteria:

- Any patient who has undergone EUS-guided ERCP (Endoscopic Retrograde
Cholangiopancreatography)for diagnosis or treatment of a pancreatico-biliary

- 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.

Type of Study:


Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:


Outcome Description:

Documentation of Safety- Number of Participants with Adverse Events; Type, frequency and intensity of adverse events

Outcome Time Frame:

3 years

Safety Issue:


Principal Investigator

Michel Kahaleh, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Weill Medical College of Cornell University


United States: Institutional Review Board

Study ID:




Start Date:

November 2011

Completion Date:

October 2015

Related 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
  • 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
  • Constriction, Pathologic
  • Diverticulum
  • Pancreatic Neoplasms
  • Pancreatitis
  • Tooth, Impacted
  • Pancreatitis, Chronic
  • Cholangiocarcinoma
  • Cholestasis
  • Bile Duct Neoplasms



Weill Cornell Medical CollegeNew York, New York  10021