- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02936960
Endoscopic Ultrasound-guided Needle-based Confocal Laser Endomicroscopy in Solid Pancreatic Masses
February 21, 2017 updated by: Yanqing Li, Shandong University
The differential diagnosis of solid pancreatic masses by endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) is currently suboptimal.
Needle-based confocal laser endomicroscopy (nCLE) is a novel endoscopic technique, which is compatible with the 19-gauge FNA needle.
Under endoscopic ultrasonography (EUS) guidance, nCLE enables real-time in vivo imaging of lesion tissues at cellular and subcellular levels.
This study aimed to describe nCLE interpretation criteria for the characterization of pancreatic masses, with histopathological correlation, and to perform the validation of these criteria.
Study Overview
Status
Unknown
Conditions
Study Type
Observational
Enrollment (Anticipated)
30
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Shandong
-
Jinan, Shandong, China, 250012
- Recruiting
- Department of Gastroenterology, Qilu Hospital, Shandong University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
The patients undergoing EUS for the diagnosis and staging of a pancreatic mass will be recruited in this study at Qilu Hospital, Shandong University.
Description
Inclusion Criteria:
- patients with any pancreatic mass
Exclusion Criteria:
- Patients aged <18 years or >80 years
- Known allergy to fluorescein dye
- Previous EUS-FNA performed within the past 3 months, and usualcontraindications to EUS-FNA
- Pregnancy or breastfeeding
- Inability to provide informed consent
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The nCLE interpretation criteria for the characterization of pancreatic masses with histopathological correlation
Time Frame: 20 months
|
20 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2016
Primary Completion (Anticipated)
December 1, 2017
Study Registration Dates
First Submitted
October 14, 2016
First Submitted That Met QC Criteria
October 14, 2016
First Posted (Estimate)
October 18, 2016
Study Record Updates
Last Update Posted (Actual)
February 23, 2017
Last Update Submitted That Met QC Criteria
February 21, 2017
Last Verified
February 1, 2017
More Information
Terms related to this study
Other Study ID Numbers
- 2016SDU-QILU-20
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 Solid Pancreatic Masses
-
The Third Xiangya Hospital of Central South UniversityUnknownSolid Pancreatic MassesChina
-
Yonsei UniversityCompletedSolid Pancreatic MassesKorea, Republic of
-
Asan Medical CenterCompletedPancreatic MassesKorea, Republic of
-
Istituto Clinico HumanitasAzienda Ospedaliera Universitaria Integrata Verona; Catholic University of... and other collaboratorsCompleted
-
Foundation for Liver ResearchCook Ireland, Ltd.CompletedPancreatic Masses | Lymph NodesFrance, Sweden, Israel, Belgium, Australia, United States, Italy, Japan, Netherlands, Spain
-
American Society for Gastrointestinal EndoscopyMidwest Biomedical Research FoundationUnknownMediastinal or Intra-abdominal Lymphadenopathy, | Pancreatic Masses, | Left Adrenal Masses, | Gastrointestinal Submucosal Lesions, and | Liver MassesUnited States
-
University Hospital, Gentofte, CopenhagenUniversity Hospital Schleswig-Holstein; University of Medicine and Pharmacy... and other collaboratorsCompletedControlled Trial Comparing the Performance of 22 Gauge Versus 25 Gauge EUS-FNA Needles (FNA-22G-25G)Pancreatic Masses | Liver Masses | Mediastinal Tumours and Lymph Nodes | Celiac, Perigastric and Peri-pancreatic Lymph Nodes | Adrenal MassesDenmark, Germany, Romania
-
University Health Network, TorontoWithdrawn
-
Brugmann University HospitalCompletedAdnexal MassesBelgium
-
Texas Tech University Health Sciences Center, El...CompletedPancreatic or Peripancreatic Lesions | Lesions in the Esophagus, Stomach, Duodenum or Rectum | Mediastinal ( Chest) Masses | Enlarged Lymph NodesUnited States