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

Weill Cornell Medicine (WCM)

Status: Unknown

Conditions: Biliary Sphincter Stenosis; Chronic Pancreatitis; Biliary Stricture; Cholangiocarcinoma; Proximal Duct Stricture; Ampullary Cancer; Peri-ampullary Diverticula; Bile Duct Cancer; Distal Duct Stricture; Impacted Stones; Biliary Obstruction; Stent Obstruction; Altered Anatomy; Pancreatic Cancer

Treatments: Procedure: EUS guided ERCP

Study type: Observational

Funder types: Other

Identifiers

NCT01522573

1111012016

Details and patient eligibility

About

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

Full 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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Exclusion criteria

• Any subject who has not undergone Endoscopic Ultrasound (EUS) guided Endoscopic retrograde cholangiopancreatography (ERCP).
• Below 18 years of age.

Trial design

1,000 participants in 1 patient group

EUS guided ERCP procedure group

Description:

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

Treatment:

Procedure: EUS guided ERCP