Utility of CholangioFlex and Fluorescent in Situ Hybridization in the Diagnosis of Malignant Biliary Strictures
This study is currently recruiting participants.
Verified September 2012 by King Chulalongkorn Memorial Hospital
Sponsor:
King Chulalongkorn Memorial Hospital
Information provided by (Responsible Party):
Rapat Pittayanon, MD, King Chulalongkorn Memorial Hospital
ClinicalTrials.gov Identifier:
NCT01501474
First received: December 27, 2011
Last updated: September 26, 2012
Last verified: September 2012
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Purpose
Utility of CholangioFlex and Fluorescent in situ Hybridization in the Diagnosis of Malignant Biliary Strictures
Objectives
- To assess the sensitivity, specificity and accuracy of CholangioFlex in malignant biliary stricture diagnosis
- 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 |
|---|
|
Malignant Biliary Strictures |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Utility of CholangioFlex and Fluorescent in Situ Hybridization in the Diagnosis of Malignant Biliary Strictures |
Further study details as provided by King Chulalongkorn Memorial Hospital:
Primary Outcome Measures:
- Increasing the detection rate of malignant biliary stricture diagnosis by using CholangioFlex (Cofocal) and/or FISH test [ Time Frame: up to 1 year ] [ Designated as safety issue: Yes ]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
| Estimated Enrollment: | 50 |
| Study Start Date: | January 2012 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
| CholangioFlex and Fluorescent in situ Hybridization(FISH) |
Show Detailed Description Eligibility| Ages Eligible for Study: | 20 Years and older |
| Genders Eligible for Study: | Both |
| 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:
- Age > 20 year-old
- All patients who are diagnosed malignant biliary stricture by 3 months and undergo ERCP in Chulalongkorn Hospital.
- All patients have to sign the consent form
Exclusion Criteria:
- Cannot follow up for 1 year
- Bleeding tendency including decompensated cirrhosis, chronic kidney disease and long-tem antiplatelets or anticoagulants
- Pregnancy
- History of fluorescein allergy
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01501474
Contacts
| Contact: Rapat Pittayanon, MD | 66813132112 | |
| Contact: Nuttapaht Namjud, Mcs. | 66894971957 |
Locations
| Thailand | |
| Rapat Pittayanon | Recruiting |
| Bangkok, Thailand, 10330 | |
| Contact: Rapat Pittayanon, MD 66813132112 rapat125@gmail.com | |
| Contact: Nuttapaht Namjud, M.Sc 66894971957 ampere_nut@hotmail.com | |
Sponsors and Collaborators
King Chulalongkorn Memorial Hospital
Investigators
| Principal Investigator: | Rapat Pittayanon, MD | Chulalongkorn Hospital |
| Study Director: | Rungsun Rerknimitr, Professor | Chulalongkorn Hospital |
More Information
Additional Information:
No publications provided
| Responsible Party: | Rapat Pittayanon, MD, King Chulalongkorn Memorial Hospital |
| ClinicalTrials.gov Identifier: | NCT01501474 History of Changes |
| Other Study ID Numbers: | RP004 |
| Study First Received: | December 27, 2011 |
| Last Updated: | September 26, 2012 |
| Health Authority: | Thailand: Ethical Committee |
Keywords provided by 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:
|
Cholestasis Constriction, Pathologic Bile Duct Diseases |
Biliary Tract Diseases Digestive System Diseases Pathological Conditions, Anatomical |
ClinicalTrials.gov processed this record on June 18, 2013