- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01522573
T-EUS for Gastrointestinal Disorders: A Multicenter Registry (EUSERCPReg)
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:
- 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
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
-
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São Paulo, Brazil, 01246-903
- Recruiting
- Prof. Dr. Everson L.A. Artifon
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Contact:
- Everson LA Artifon, MD
- Phone Number: 3061-7345
- Email: eartifon@hotmail.com
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Principal Investigator:
- Everson LA Artifon, MD
-
-
-
-
New York
-
New York, New York, United States, 10021
- Recruiting
- Weill Cornell Medical College
-
Contact:
- Monica Gaidhane, MPH
- Phone Number: 646-962-4796
- Email: mog2012@med.cornell.edu
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
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.
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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.
|
Endoscopic ultrasound guided (EUS) endoscopic retrograde cholangiopancreatography (ERCP)
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety
Time Frame: 3 years
|
Documentation of Safety- Number of Participants with Adverse Events; Type, frequency and intensity of adverse events
|
3 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Efficacy
Time Frame: 3 years
|
Documentation of efficacy: Technical and clinical success rates.
|
3 years
|
Survival duration
Time Frame: 3 years
|
Documentation of response rates and overall survival duration.
|
3 years
|
Collaborators and Investigators
Publications and helpful links
General Publications
- 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.
- 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.
- Siddiqui A, Kunda R, Tyberg A, Arain MA, Noor A, Mumtaz T, Iqbal U, Loren DE, Kowalski TE, Adler DG, Saumoy M, Gaidhane M, Mallery S, Christiansen EM, Nieto J, Kahaleh M. Three-way comparative study of endoscopic ultrasound-guided transmural gallbladder drainage using lumen-apposing metal stents versus endoscopic transpapillary drainage versus percutaneous cholecystostomy for gallbladder drainage in high-risk surgical patients with acute cholecystitis: clinical outcomes and success in an International, Multicenter Study. Surg Endosc. 2019 Apr;33(4):1260-1270. doi: 10.1007/s00464-018-6406-7. Epub 2018 Sep 12.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- Pancreatic Cancer
- Biliary obstruction
- Cholangiocarcinoma
- Chronic pancreatitis
- Endoscopic ultrasound
- Multicenter
- Ampullary Cancer
- Endoscopic Retrograde Cholangiopancreatography
- Biliary Stricture
- Bile Duct Cancer
- Stent obstruction
- Proximal duct stricture
- Distal duct stricture
- Biliary sphincter stenosis
- Impacted stones
- Peri-ampullary diverticula
- Altered anatomy
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Adenocarcinoma
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Endocrine System Diseases
- Digestive System Neoplasms
- Endocrine Gland Neoplasms
- Gastroenteritis
- Stomatognathic Diseases
- Pathological Conditions, Anatomical
- Tooth Diseases
- Biliary Tract Diseases
- Pancreatic Diseases
- Bile Duct Diseases
- Biliary Tract Neoplasms
- Pancreatic Neoplasms
- Gastrointestinal Diseases
- Digestive System Diseases
- Constriction, Pathologic
- Cholangiocarcinoma
- Pancreatitis
- Pancreatitis, Chronic
- Diverticulum
- Diverticular Diseases
- Tooth, Impacted
- Bile Duct Neoplasms
Other Study ID Numbers
- 1111012016
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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