T-EUS for Gastrointestinal Disorders: A Multicenter Registry

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Brief Title

T-EUS for Gastrointestinal Disorders: A Multicenter Registry

Official Title

Therapeutic Endoscopic Ultrasound (T-EUS) Guided Procedures in the Management of Gastrointestinal Disorders: A Multicenter Registry.

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
    

Detailed Description

      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.
    


Study Type

Observational


Primary Outcome

Safety

Secondary Outcome

 Efficacy

Condition

Cholangiocarcinoma

Intervention

EUS guided ERCP

Study Arms / Comparison Groups

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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure

Estimated Enrollment

1000

Start Date

November 2011

Completion Date

December 30, 2018

Primary Completion Date

December 30, 2018

Eligibility Criteria

        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.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Michel Kahaleh, MD, , 

Location Countries

Brazil

Location Countries

Brazil

Administrative Informations


NCT ID

NCT01522573

Organization ID

1111012016


Responsible Party

Principal Investigator

Study Sponsor

Weill Medical College of Cornell University


Study Sponsor

Michel Kahaleh, MD, Principal Investigator, Weill Medical College of Cornell University


Verification Date

February 2017