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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

Tracking Information
First Submitted Date April 12, 2018
First Posted Date April 20, 2018
Last Update Posted Date April 24, 2018
Actual Study Start Date January 1, 2010
Estimated Primary Completion Date July 1, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 12, 2018)
Diagnostic accuracy [ Time Frame: 12 months post-EUS ]
Overall accuracy of ERCP and EUS
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03504293 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: April 12, 2018)
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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The Diagnostic Value of Combinatory EUS and ERCP in Unclear Lesions
Official Title Sahlgrenska EUS ERCP Study
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.

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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Patients with unclear lesions or strictures in the biliary tract
Condition
  • Neoplasms
  • Biliary Stricture
  • Biliary Tract Neoplasms
  • Biliary Tract Diseases
Intervention Procedure: Combinatory EUS and ERCP
EUS performed as a supplementary procedure in addition to ERCP
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: April 12, 2018)
80
Original Estimated Enrollment Same as current
Estimated Study Completion Date March 1, 2019
Estimated Primary Completion Date July 1, 2018   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Per Hedenstrom, PhD +46 703288291 per.hedenstrom@vgregion.se
Contact: Riadh Sadik, Ass Prof +46 733 641355 riadh.sadik@vgregion.se
Listed Location Countries Sweden
Removed Location Countries  
 
Administrative Information
NCT Number NCT03504293
Other Study ID Numbers EUS-ERCP Study
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Per Hedenström, Sahlgrenska University Hospital, Sweden
Study Sponsor Sahlgrenska University Hospital, Sweden
Collaborators Not Provided
Investigators
Principal Investigator: Riadh Sadik, Ass Prof Sahlgrenska University Hospital, Gothenburg
PRS Account Sahlgrenska University Hospital, Sweden
Verification Date April 2018