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The Diagnostic Value of Combinatory EUS and ERCP in Unclear Lesions

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ClinicalTrials.gov Identifier: NCT03504293
Recruitment Status : Recruiting
First Posted : April 20, 2018
Last Update Posted : April 24, 2018
Sponsor:
Information provided by (Responsible Party):
Per Hedenström, Sahlgrenska University Hospital, Sweden

Brief Summary:

ERCP with brush cytology has a poor to moderate accuracy in unclear biliary lesions. Endoscopic ultrasound (EUS) with fine needle aspiration (FNA) for cytology may override some of these shortcomings.

The current prospective study, performed in a tertiary University center, aims to study the feasibility, the accuracy and the clinical value of combinatory ERCP and EUS in unclear biliary lesions.


Condition or disease Intervention/treatment
Neoplasms Biliary Stricture Biliary Tract Neoplasms Biliary Tract Diseases Procedure: Combinatory EUS and ERCP

Detailed Description:

The eligible study participants with unclear biliary lesions referred for an ERCP to the Sahlgrenska Univeristy Hospital endoscopy unit will be subjected to ERCP with/without brush cytology followed by EUS with/without FNA.

The results of ERCP and EUS will be compared to the pathology report of surgical specimens in resected patients or to clinical follow up at 12 months post-EUS in non-resected patients.


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Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Sahlgrenska EUS ERCP Study
Actual Study Start Date : January 1, 2010
Estimated Primary Completion Date : July 1, 2018
Estimated Study Completion Date : March 1, 2019

Intervention Details:
  • Procedure: Combinatory EUS and ERCP
    EUS performed as a supplementary procedure in addition to ERCP


Primary Outcome Measures :
  1. Diagnostic accuracy [ Time Frame: 12 months post-EUS ]
    Overall accuracy of ERCP and EUS


Secondary Outcome Measures :
  1. Adverse event rate [ Time Frame: 30 days post-EUS ]
    The number of patients ending up with some type of complication related to ERCP or EUS



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with unclear lesions or strictures in the biliary tract
Criteria

Inclusion Criteria:

  • Patients with unclear lesions or strictures in the biliary tract referred for endoscopy work up

Exclusion Criteria:

  • Patients unwilling to participate
  • Patients unfit for EUS and ERCP

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03504293


Contacts
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Contact: Per Hedenstrom, PhD +46 703288291 per.hedenstrom@vgregion.se
Contact: Riadh Sadik, Ass Prof +46 733 641355 riadh.sadik@vgregion.se

Locations
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Sweden
Sahlgrenska University Hospital Recruiting
Gothenburg, Sweden, 413 45
Contact: Per Hedenstrom, PhD    +46 703288291    per.hedenstrom@vgregion.se   
Sponsors and Collaborators
Sahlgrenska University Hospital, Sweden
Investigators
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Principal Investigator: Riadh Sadik, Ass Prof Sahlgrenska University Hospital, Gothenburg

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Responsible Party: Per Hedenström, MD PhD, Sahlgrenska University Hospital, Sweden
ClinicalTrials.gov Identifier: NCT03504293     History of Changes
Other Study ID Numbers: EUS-ERCP Study
First Posted: April 20, 2018    Key Record Dates
Last Update Posted: April 24, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Per Hedenström, Sahlgrenska University Hospital, Sweden:
Endosonography
Endoscopic retrograde choledochography

Additional relevant MeSH terms:
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Neoplasms
Biliary Tract Neoplasms
Biliary Tract Diseases
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases