ClinicalTrials.gov
ClinicalTrials.gov Menu

Utility of CholangioFlex and Fluorescent in Situ Hybridization in the Diagnosis of Malignant Biliary Strictures

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01501474
Recruitment Status : Terminated (No suitable case available and many techinical error)
First Posted : December 29, 2011
Last Update Posted : July 3, 2014
Sponsor:
Information provided by (Responsible Party):
Rapat Pittayanon, MD, King Chulalongkorn Memorial Hospital

Brief Summary:

Utility of CholangioFlex and Fluorescent in situ Hybridization in the Diagnosis of Malignant Biliary Strictures

Objectives

  1. To assess the sensitivity, specificity and accuracy of CholangioFlex in malignant biliary stricture diagnosis
  2. To assess the sensitivity, specificity and accuracy of Fluorescent in situ Hybridization(FISH) in malignant biliary stricture diagnosis

Study design One academic center, prospective, diagnostic study

Research Methodology Target population: Patients who are diagnosed malignant biliary stricture. Sample population: Patients who are diagnosed malignant biliary stricture in Chulalongkorn Hospital


Condition or disease
Malignant Biliary Strictures

  Show Detailed Description

Study Type : Observational
Actual Enrollment : 5 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Utility of CholangioFlex and Fluorescent in Situ Hybridization in the Diagnosis of Malignant Biliary Strictures
Study Start Date : January 2012
Estimated Primary Completion Date : July 2014
Estimated Study Completion Date : July 2014

Group/Cohort
CholangioFlex and Fluorescent in situ Hybridization(FISH)



Primary Outcome Measures :
  1. Increasing the detection rate of malignant biliary stricture diagnosis by using CholangioFlex (Cofocal) and/or FISH test [ Time Frame: up to 1 year ]
    If investigator can detect malignant biliary stricture more than present, the care giver can treat these patients properly. Consequently, the mortality rate of malignant biliary stricture will be decrease.


Biospecimen Retention:   Samples Without DNA
Brush cytology and FISH test


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Due to no study in Thai population before, investigator will perform pilot study in 50 malignant biliary stricture patients
Criteria

Inclusion Criteria:

  1. Age > 20 year-old
  2. All patients who are diagnosed malignant biliary stricture by 3 months and undergo ERCP in Chulalongkorn Hospital.
  3. All patients have to sign the consent form

Exclusion Criteria:

  1. Cannot follow up for 1 year
  2. Bleeding tendency including decompensated cirrhosis, chronic kidney disease and long-tem antiplatelets or anticoagulants
  3. Pregnancy
  4. History of fluorescein allergy

Information from the National Library of Medicine

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): NCT01501474


Locations
Thailand
Rapat Pittayanon
Bangkok, Thailand, 10330
Sponsors and Collaborators
King Chulalongkorn Memorial Hospital
Investigators
Principal Investigator: Rapat Pittayanon, MD Chulalongkorn Hospital
Study Director: Rungsun Rerknimitr, Professor Chulalongkorn Hospital

Additional Information:
Responsible Party: Rapat Pittayanon, MD, King Chulalongkorn Memorial Hospital
ClinicalTrials.gov Identifier: NCT01501474     History of Changes
Other Study ID Numbers: RP004
First Posted: December 29, 2011    Key Record Dates
Last Update Posted: July 3, 2014
Last Verified: July 2014

Keywords provided by Rapat Pittayanon, MD, King Chulalongkorn Memorial Hospital:
Confocal
malignant biliary stricture
Sensitivity, specificity and accuracy of CholangioFlex in malignant biliary stricture diagnosis
sensitivity, specificity and accuracy of Fluorescent in situ Hybridization(FISH) in malignant biliary stricture diagnosis

Additional relevant MeSH terms:
Constriction, Pathologic
Cholestasis
Pathological Conditions, Anatomical
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases