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
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|
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.
|Study Type :||Observational|
|Estimated Enrollment :||80 participants|
|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|
- Procedure: Combinatory EUS and ERCP
EUS performed as a supplementary procedure in addition to ERCP
- Diagnostic accuracy [ Time Frame: 12 months post-EUS ]Overall accuracy of ERCP and EUS
- 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
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
|Contact: Per Hedenstrom, PhD||+46 email@example.com|
|Contact: Riadh Sadik, Ass Prof||+46 733 firstname.lastname@example.org|
|Sahlgrenska University Hospital||Recruiting|
|Gothenburg, Sweden, 413 45|
|Contact: Per Hedenstrom, PhD +46 703288291 email@example.com|
|Principal Investigator:||Riadh Sadik, Ass Prof||Sahlgrenska University Hospital, Gothenburg|