Efficacy of EUS guided Confocal laser endomicroscopy for diagnosis of solid pancreatic mass
Study ID: TCTR20140402001
Current status: Completed
Last Updated: April 02, 2014
Tracking Information
Date of Registration in Primary Registry: April 02, 2014
Date of First Enrollment: July 07, 2013 (Actual)
Target Sample Size: 22
Last Updated Date: April 02, 2014
Primary Outcome(s):
  • Outcome name: Sensitivity of confocal endomicroscopy in diagnosis pancreatic mass
       Metric/method of measurement: sensitivity rate
       Time point: after the study was completed
       Safety Issue?: No


  • Key Secondary Outcomes:
  • Outcome name: Specifity of confocal endomicroscopy in diagnosis pancreatic mass
       Metric/method of measurement: specificity rate
       Time point: at tyhe end of the study
       Safety Issue?: No


  • Descriptive Information
    Public Title: Efficacy of EUS guided Confocal laser endomicroscopy for diagnosis of solid pancreatic mass
    Scientific Title: Efficacy of EUS guided Confocal laser endomicroscopy for diagnosis of solid pancreatic mass
    Brief Summary: To differentiated pancreatic mass, we have to integrate informations from physical examination, blood chemistry and radiography. The gold standard of diagnosis is pathology. Endoscopic ultrasound (EUS) is one of utility to get the specimen and efficacy in previous study is 70-90%. The main factor to improve efficacy is pathologist. However, limited pathologist and service made EUS lowered efficacy. In recent years, there is high resolution technology, Confocal endomicroscopy. This microscopy allows the physicians to identify changes and cancer cells early. To our knowledge, there is no study of confocal endomicroscopy in pancreatic mass to differentiate between benign or malignant.
    Detailed Description: The patients with unresectable pancreatic mass in King Chulalongkorn Memorial Hospital will be included. The informations of physical examinations, laboratory investigations and result of abdominal computed tomography will be recorded. The patients will be proceed to endocscope examine and collect pancreatic tissue. The abnormal finding from confocal endomicroscopy will be recorded. The tissues will be sent to Pathological department, King Chulalongkorn Memorial Hospital.
    Study Design: Allocation: Non-randomized
    Control:
    Study Endpoint Classification: N/A
    Intervention Model: No Intervention
    Number of Groups: 1
    Masking: (Masked Roles: )
    Primary Purpose: Diagnostic
    Study Phase: N/A
    Health Condition(s) or Problem(s) Studied: Solid pancreatic mass(es) that is(are) indicated for transgastric EUS-FNA.
    Study Groups:
  • Group: 1
  • Group Name: Patients with solid pancreatic mass
    Descriptions: Any patients with solid pancreatic mass(es) who undergo EUS-FNA and allow physicians to use confocal laser endomicroscopy for an evaluation of the mass.
    Recruitment Information
    Recruitment Status: Completed
    Estimated Enrollment: 22
    Study Start Date (First enrollment): July 07, 2013
    Primary Completion Date: February 19, 2014
    Inclusion Criteria:
    Inclusion Criteria
    Gender: Both
    Age Limit: Minimum 18 Years : Maximum N/A (No limit)
    1 Patient who has solid pancreatic mass es that can be approached by transgastric EUS FNA and EUS guided Confocal endomicroscopy In addition if the mass was likely cancer it should be considered as unresectable ones
    2 Age more than 18 years
    3 Patient who has to get the tissue for diagnosis
    4 The patient permission







    Exclusion Criteria
    1 Age less than 18 years
    2 The pancreatic mass that cannot be accessed by Confocal endcomicroscpy and or considered as potentially resectable pancreatic cancer
    3 Pregnancy
    4 Not permitted



    Accept Healthy Volunteers: No
    Countries of Recruitment Thailand
    Contact for Public Queries:
    Contact for Public Query's Name: Pradermchai Kongkam
    Degree: MD
    Phone: 6622564265
    Email: eusdata@gmail.com
    Postal Address: 1873 Rama IV Road Patumwan
    State/Province: Bangkok        Postal Code: 10330
    Country: Thailand
    Administrative Information
    Primary Registry Site: Thai Clinical Trials Registry
    Trial Identification Number: TCTR20140402001
    Secondary Identifying Numbers: Nil known
    Source(s) of Monetary or Material Supports: Faculty of medicine Chulalongkorn University
    Study Primary Sponsor: Faculty of medicine Chulalongkorn University
    Study Secondary Sponsor: 1.) Faculty of medicine Chulalongkorn University
    Contact for Scientific Queries:
    Contact for Scientific Query's Name: Pradermchai Kongkam
    Degree: MD
    Phone: 6622564265
    Email: kongkam@hotmail.com
    Postal Address: 1873 Rama IV road Patumwan
    State/Province: Bangkok        Postal Code: 10330
    Country: Thailand
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