- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03504293
The Diagnostic Value of Combinatory EUS and ERCP in Unclear Lesions
Sahlgrenska EUS ERCP Study
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.
Study Overview
Status
Intervention / Treatment
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
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Gothenburg, Sweden, 413 45
- Sahlgrenska University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Diagnostic accuracy
Time Frame: 12 months post-EUS
|
Overall accuracy of ERCP and EUS
|
12 months post-EUS
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
30 days post-EUS
|
Collaborators and Investigators
Investigators
- Principal Investigator: Riadh Sadik, Ass prof, Sahlgrenska University Hospital, Gothenburg
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EUS-ERCP Study
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Neoplasms
-
GlaxoSmithKlineCompleted
-
Amphia HospitalRecruitingColonic Neoplasms MalignantNetherlands
-
Marquette General Health SystemUpper Michigan Brain Tumor CenterWithdrawnGlioma | MeningiomaUnited States
-
Ann & Robert H Lurie Children's Hospital of ChicagoCompletedBrain Stem Neoplasms, Primary | Neoplasms, Brain StemUnited States
-
GlaxoSmithKlineRecruitingNeoplasms, RectalUnited States, France, Italy, Japan, Spain, United Kingdom, Germany, Korea, Republic of, Canada, Netherlands
-
Russian Society of Colorectal SurgeonsRecruitingNeoplasms,ColorectalRussian Federation
-
Third Affiliated Hospital, Sun Yat-Sen UniversityRecruiting
-
Novartis PharmaceuticalsBayerCompletedColorectal Neoplasms | Rectal Neoplasms | Colonic NeoplasmsUnited States, Germany, Belgium, Canada, Spain, United Kingdom, Taiwan, France, Switzerland, Sweden, Portugal, New Zealand, Italy, Slovakia, Australia, Austria, Brazil, Hong Kong
-
University of Michigan Rogel Cancer CenterNational Cancer Institute (NCI); Department of Health and Human Services; Early... and other collaboratorsRecruitingColonic NeoplasmsUnited States, Canada, Australia
Clinical Trials on Combinatory EUS and ERCP
-
Weill Medical College of Cornell UniversityUnknownPancreatic Cancer | Cholangiocarcinoma | Bile Duct Cancer | Chronic Pancreatitis | Biliary Stricture | Biliary Obstruction | Ampullary Cancer | Stent Obstruction | Proximal Duct Stricture | Distal Duct Stricture | Biliary Sphincter Stenosis | Impacted Stones | Peri-ampullary Diverticula | Altered AnatomyUnited States, Brazil
-
Woo Hyun PaikCompleted
-
Istituto Clinico HumanitasRecruitingDISTAL MALIGNANT BILIARY OBSTRUCTIONItaly
-
Peking Union Medical College HospitalNot yet recruitingJaundice, Obstructive | Cholangiopancreatography, Endoscopic Retrograde | Endoscopic Ultrasound-Guided Drainage
-
McGill University Health Centre/Research Institute...Completed
-
Samsung Medical CenterCompletedTumor Appearance of Biliary System ObstructionKorea, Republic of
-
Loma Linda UniversityWithdrawnLiver Graft Dysfunction
-
Prince of Songkla UniversityCompletedCommon Bile Duct CalculiThailand
-
California Pacific Medical Center Research InstituteCompletedJaundice | Bile Duct Obstruction | Pancreaticobiliary CancersUnited States
-
California Pacific Medical Center Research InstituteUniversity of California, Los Angeles; Northwestern University; University of...CompletedDisorders of Gallbladder | Disorders of Biliary TractUnited States