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

Sponsor

Weill Medical College of Cornell University (Other)

Overall Status

Unknown status

CT.gov ID

NCT01522573

Collaborator

(none)

1,000

Enrollment

Locations

85.9

Duration (Months)

500

Patients Per Site

5.8

Patients Per Site Per Month

Study Details

Study Description

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:

EUS-Coils placement
EUS Glue injection
EUS-Fiducial placement
EUS-Neurolysis
EUS-Stent placement
EUS-alcohol injection
EUS-fluid collection, abscess or cavity drainage
EUS guided ductal drainage
EUS-guided Ablation
EUS-guided anastomosis 11. EUS Guided ERCP for gallbladder, pancreatic duct or biliary duct drainage

Condition or Disease	Intervention/Treatment	Phase
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 Design

Study Type:

Observational

Anticipated 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 :

Nov 1, 2011

Anticipated Primary Completion Date :

Dec 30, 2018

Anticipated Study Completion Date :

Dec 30, 2018

Arms and Interventions

Arm	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 Names: EUS ERCP

Arm

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 Names:

EUS ERCP

Outcome Measures

Primary Outcome Measures

Safety [3 years]
Documentation of Safety- Number of Participants with Adverse Events; Type, frequency and intensity of adverse events

Secondary Outcome Measures

Efficacy [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.
Survival duration [3 years]
Documentation of response rates and overall survival duration.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.