Clinical trial NCT01522573: T-EUS for Gastrointestinal Disorders: A Multicenter Registry
Official title: Therapeutic Endoscopic Ultrasound (T-EUS) Guided Procedures in the Management of Gastrointestinal Disorders: A Multicenter Registry.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: 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
Keywords: 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
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
First posted: 2012-01-31
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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

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.

Eligibility 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.

Primary outcomes:
measure: Safety
timeFrame: 3 years
Secondary outcomes:
measure: Efficacy
timeFrame: 3 years
measure: Survival duration
timeFrame: 3 years
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
city: São Paulo
country: Brazil
facility: Prof. Dr. Everson L.A. Artifon
Study officials:
affiliation: Weill Medical College of Cornell University
name: Michel Kahaleh, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tyberg A, Kats D, Choi A, Gaidhane M, Nieto J, Kahaleh M. Endoscopic Ultrasound Guided Gastroenterostomy: What Is the Learning Curve? J Clin Gastroenterol. 2021 Sep 1;55(8):691-693. doi: 10.1097/MCG.0000000000001400.
citation: Kumta NA, Tyberg A, Bhagat VH, Siddiqui AA, Kowalski TE, Loren DE, Desai AP, Sarkisian AM, Brown EG, Karia K, Gaidhane M, Kedia P, Tarnasky PR, Patel U, Adler D, Taylor LJ, Petrone M, Arcidiacono P, Yachimski PS, Weine D, Sundararajan S, Deprez PH, Mouradides C, Ho S, Javed S, Easler JJ, Raijman I, Vazquez-Sequeiros E, Sawhney M, Berzin TM, Kahaleh M. EUS-guided drainage of pancreatic fluid collections using lumen apposing metal stents: An international, multicenter experience. Dig Liver Dis. 2019 Nov;51(11):1557-1561. doi: 10.1016/j.dld.2019.05.033. Epub 2019 Jul 2.
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citation: Tyberg A, Sharaiha RZ, Kedia P, Kumta N, Gaidhane M, Artifon E, Giovannini M, Kahaleh M. EUS-guided pancreatic drainage for pancreatic strictures after failed ERCP: a multicenter international collaborative study. Gastrointest Endosc. 2017 Jan;85(1):164-169. doi: 10.1016/j.gie.2016.07.030. Epub 2016 Jul 25.
citation: Kahaleh M, Perez-Miranda M, Artifon EL, Sharaiha RZ, Kedia P, Penas I, De la Serna C, Kumta NA, Marson F, Gaidhane M, Boumitri C, Parra V, Rondon Clavo CM, Giovannini M. International collaborative study on EUS-guided gallbladder drainage: Are we ready for prime time? Dig Liver Dis. 2016 Sep;48(9):1054-7. doi: 10.1016/j.dld.2016.05.021. Epub 2016 Jun 3.
citation: Tyberg A, Perez-Miranda M, Sanchez-Ocana R, Penas I, de la Serna C, Shah J, Binmoeller K, Gaidhane M, Grimm I, Baron T, Kahaleh M. Endoscopic ultrasound-guided gastrojejunostomy with a lumen-apposing metal stent: a multicenter, international experience. Endosc Int Open. 2016 Mar;4(3):E276-81. doi: 10.1055/s-0042-101789.
citation: Kedia P, Tyberg A, Kumta NA, Gaidhane M, Karia K, Sharaiha RZ, Kahaleh M. EUS-directed transgastric ERCP for Roux-en-Y gastric bypass anatomy: a minimally invasive approach. Gastrointest Endosc. 2015 Sep;82(3):560-5. doi: 10.1016/j.gie.2015.03.1913. Epub 2015 May 5.