EUS-Guided ERCP Multicenter Registry (EUSERCPReg)

This study is currently recruiting participants.
Verified December 2012 by Weill Medical College of Cornell University
Sponsor:
Information provided by (Responsible Party):
Michel Kahaleh, Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT01522573
First received: January 26, 2012
Last updated: December 18, 2012
Last verified: December 2012

January 26, 2012
December 18, 2012
November 2011
October 2015   (final data collection date for primary outcome measure)
Safety [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
Documentation of Safety- Number of Participants with Adverse Events; Type, frequency and intensity of adverse events
Same as current
Complete list of historical versions of study NCT01522573 on ClinicalTrials.gov Archive Site
  • Efficacy [ Time Frame: 3 years ] [ Designated as safety issue: No ]

    Documentation of efficacy: Technical and clinical success rates.

    • Technical Success rate will be derived from reported success or failure of technical feasibility and conduction of a specific EUS Guided ERCP procedure for a pancreatico-biliary condition.
    • Clinical success rate will be derived from reported of clinical success hallmarks such as biliary or pancreatic drainage, reduction in total bilirubin, formation of a fistula, immediate and eventual alleviation of symptoms or complaints within a specific period of time, etc. for that particular pancreatico-biliary disorder.
  • Survival duration [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    Documentation of response rates and overall survival duration.
  • Efficacy [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Documentation of efficacy: Technical and clinical success rates
  • Survival duration [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    Documentation of response rates and overall survival duration.
Not Provided
Not Provided
 
EUS-Guided ERCP Multicenter Registry
Endoscopic Ultrasound (EUS)-Guided Endoscopic Retrograde Cholangiopancreatography (ERCP) in the Management of Pancreatico-biliary Disorders: A Multicenter Registry.

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.

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Subjects who has undergone Endoscopic Ultrasound (EUS) guided Endoscopic retrograde cholangiopancreatography (ERCP) procedure for diagnosis or treatment of a pancreatico-biliary disorder.

Above 18 years of age.

  • 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
Procedure: EUS guided ERCP
Endoscopic ultrasound guided (EUS) endoscopic retrograde cholangiopancreatography (ERCP)
Other Name: EUS ERCP
EUS guided ERCP procedure group
Subjects who will undergo Endoscopic Ultrasound (EUS) guided Endoscopic retrograde cholangiopancreatography (ERCP) procedures for their pancreatico-biliary conditions.
Intervention: Procedure: EUS guided ERCP
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1000
October 2015
October 2015   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Not Provided
United States
 
NCT01522573
1111012016
No
Michel Kahaleh, Weill Medical College of Cornell University
Weill Medical College of Cornell University
Not Provided
Principal Investigator: Michel Kahaleh, MD Weill Medical College of Cornell University
Weill Medical College of Cornell University
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP