Pancreatic Cancer Clinical Trial
Official title:
Therapeutic Endoscopic Ultrasound (T-EUS) Guided Procedures in the Management of Gastrointestinal 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.
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
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.
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