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T-EUS for Gastrointestinal Disorders: A Multicenter Registry (EUSERCPReg)

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ClinicalTrials.gov Identifier: NCT01522573
Recruitment Status : Recruiting
First Posted : January 31, 2012
Last Update Posted : February 20, 2017
Sponsor:
Information provided by (Responsible Party):
Michel Kahaleh, Weill Medical College of Cornell University

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

Condition or disease Intervention/treatment
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

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
Estimated Enrollment : 1000 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Therapeutic Endoscopic Ultrasound (T-EUS) Guided Procedures in the Management of Gastrointestinal Disorders: A Multicenter Registry.
Study Start Date : November 2011
Estimated Primary Completion Date : December 30, 2018
Estimated Study Completion Date : December 30, 2018


Group/Cohort Intervention/treatment
EUS guided ERCP procedure group
Subjects who will undergo Endoscopic Ultrasound (EUS) guided Endoscopic retrograde cholangiopancreatography (ERCP) procedures for their pancreatico-biliary conditions.
Procedure: EUS guided ERCP
Endoscopic ultrasound guided (EUS) endoscopic retrograde cholangiopancreatography (ERCP)
Other Name: EUS ERCP



Primary Outcome Measures :
  1. Safety [ Time Frame: 3 years ]
    Documentation of Safety- Number of Participants with Adverse Events; Type, frequency and intensity of adverse events


Secondary Outcome Measures :
  1. Efficacy [ Time Frame: 3 years ]

    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.

  2. Survival duration [ Time Frame: 3 years ]
    Documentation of response rates and overall survival duration.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01522573


Locations
United States, New York
Weill Cornell Medical College Recruiting
New York, New York, United States, 10021
Contact: Michel Kahaleh, MD    646-962-4797    mkahaleh@gmail.com   
Contact: Monica Gaidhane, MPH    646-962-4796    mog2012@med.cornell.edu   
Principal Investigator: Michel Kahaleh, MD         
Brazil
Prof. Dr. Everson L.A. Artifon Recruiting
São Paulo, Brazil, 01246-903
Contact: Everson LA Artifon, MD    3061-7345    eartifon@hotmail.com   
Principal Investigator: Everson LA Artifon, MD         
Sponsors and Collaborators
Weill Medical College of Cornell University
Investigators
Principal Investigator: Michel Kahaleh, MD Weill Medical College of Cornell University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Michel Kahaleh, Chief, Advanced Endoscopy, Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT01522573     History of Changes
Other Study ID Numbers: 1111012016
First Posted: January 31, 2012    Key Record Dates
Last Update Posted: February 20, 2017
Last Verified: February 2017

Keywords provided by Michel Kahaleh, Weill Medical College of Cornell University:
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

Additional relevant MeSH terms:
Pancreatic Diseases
Pancreatic Neoplasms
Pancreatitis
Cholangiocarcinoma
Constriction, Pathologic
Pancreatitis, Chronic
Bile Duct Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Cholestasis
Tooth, Impacted
Diverticulum
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Pathological Conditions, Anatomical
Biliary Tract Neoplasms
Bile Duct Diseases
Biliary Tract Diseases
Tooth Diseases
Stomatognathic Diseases