NCT01522573

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:
  • 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

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2011

Longer than P75 for all trials

Geographic Reach
2 countries

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 26, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 31, 2012

Completed
6.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2018

Completed
Last Updated

February 20, 2017

Status Verified

February 1, 2017

Enrollment Period

7.2 years

First QC Date

January 26, 2012

Last Update Submit

February 16, 2017

Conditions

CholangiocarcinomaPancreatic CancerBile Duct CancerBiliary StrictureBiliary ObstructionStent ObstructionProximal Duct StrictureDistal Duct StrictureAmpullary CancerBiliary Sphincter StenosisImpacted StonesChronic PancreatitisPeri-ampullary DiverticulaAltered Anatomy

Keywords

CholangiocarcinomaPancreatic CancerBile Duct CancerBiliary StrictureBiliary obstructionStent obstructionProximal duct strictureDistal duct strictureAmpullary CancerBiliary sphincter stenosisImpacted stonesChronic pancreatitisPeri-ampullary diverticulaAltered anatomyEndoscopic ultrasoundEndoscopic Retrograde CholangiopancreatographyMulticenter

Outcome Measures

Primary Outcomes (1)

  • Safety

    Documentation of Safety- Number of Participants with Adverse Events; Type, frequency and intensity of adverse events

    3 years

Secondary Outcomes (2)

  • Efficacy

    3 years

  • Survival duration

    3 years

Study Arms (1)

EUS guided ERCP procedure group

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

Procedure: EUS guided ERCP

Interventions

EUS guided ERCPPROCEDURE

Endoscopic ultrasound guided (EUS) endoscopic retrograde cholangiopancreatography (ERCP)

Also known as: EUS ERCP
EUS guided ERCP procedure group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Weill Cornell Medical College

New York, New York, 10021, United States

RECRUITING

Prof. Dr. Everson L.A. Artifon

São Paulo, 01246-903, Brazil

RECRUITING

Related Publications (7)

  • 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.

    PMID: 32740096DERIVED

  • 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.

    PMID: 31272934DERIVED

  • 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.

    PMID: 30209610DERIVED

  • 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.

    PMID: 27460387DERIVED

  • 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.

    PMID: 27328985DERIVED

  • 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.

    PMID: 27004243DERIVED

  • 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.

    PMID: 25952086DERIVED

MeSH Terms

Conditions

CholangiocarcinomaPancreatic NeoplasmsBile Duct NeoplasmsPancreatitis, Chronic

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsDigestive System NeoplasmsNeoplasms by SiteEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System DiseasesBiliary Tract NeoplasmsBile Duct DiseasesBiliary Tract DiseasesPancreatitisChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Michel Kahaleh, MD

    Weill Medical College of Cornell University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief, Advanced Endoscopy

Study Record Dates

First Submitted

January 26, 2012

First Posted

January 31, 2012

Study Start

November 1, 2011

Primary Completion

December 30, 2018

Study Completion

December 30, 2018

Last Updated

February 20, 2017

Record last verified: 2017-02

Locations

BR(1)US(1)