T-EUS for Gastrointestinal Disorders: A Multicenter Registry

Pancreatic Cancer Clinical Trial

— EUSERCPReg  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01522573
• Other study ID #: 1111012016
• Status: Recruiting
• Phase: N/A
• First received: January 26, 2012
• Last updated: February 16, 2017
• Start date: November 2011
• Est. completion date: December 30, 2018

Study information

• Verified date: February 2017
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 30, 2018
• Est. primary completion date: December 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Altered Anatomy
• Ampullary Cancer
• Bile Duct Cancer
• Bile Duct Neoplasms
• Biliary Obstruction
• Biliary Sphincter Stenosis
• Biliary Stricture
• Cholangiocarcinoma
• Cholestasis
• Chronic Pancreatitis
• Constriction, Pathologic
• Digestive System Diseases
• Distal Duct Stricture
• Diverticulum
• Gastrointestinal Diseases
• Impacted Stones
• Pancreatic Cancer
• Pancreatic Neoplasms
• Pancreatitis
• Pancreatitis, Chronic
• Peri-ampullary Diverticula
• Proximal Duct Stricture
• Stent Obstruction
• Tooth, Impacted

Intervention

Procedure:
• EUS guided ERCP
Endoscopic ultrasound guided (EUS) endoscopic retrograde cholangiopancreatography (ERCP)

Locations

Country	Name	City	State
Brazil	Prof. Dr. Everson L.A. Artifon	São Paulo
United States	Weill Cornell Medical College	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University

Countries where clinical trial is conducted

United States,  Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety	Documentation of Safety- Number of Participants with Adverse Events; Type, frequency and intensity of adverse events	3 years
Secondary	Efficacy	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.	3 years
Secondary	Survival duration	Documentation of response rates and overall survival duration.	3 years