TerminatedNot Applicable

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

Stopped: No suitable case available and many techinical error

Thailand5 participantsStarted 2012-01

Plain-language 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

Who can participate

Age range20 Years

SexALL

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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

What they're measuring

Increasing the detection rate of malignant biliary stricture diagnosis by using CholangioFlex (Cofocal) and/or FISH test

Timeframe: up to 1 year

Trial details

NCT IDNCT01501474

SponsorKing Chulalongkorn Memorial Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2014-07

View on ClinicalTrials.gov More Malignant Biliary Strictures trials