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

Study Overview
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Brief Summary
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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

Detailed Description
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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 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 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 Timeline: From January 2012 to December 2013 Sample size Due to no study in Thai population before, investigator will perform pilot study in 50 malignant biliary stricture patients Method All patients had informed the consent. Take the history, physical examination and then fill in the record form 3.5 ml of blood sampling for CA19-9 and 20 ml for further test by keeping in -20c temperature for 5 years 4.Set confocal endomicroscopy at the same session of ERCP 5.After successfully cannulation; 10% Fluorescein sodium 2.5 ml was injected intravenously. Confocal endomicroscopy (CholangioFlex) was performed at the suspected area. The video will record the images with Cellvizio program recorder. 6.Brush cytology was performed 7.Record the duration and complication of the procedure 8.Send the tissues to one clinically-blinded GI pathologist for pathological diagnosis and FISH test 9.Compare the pathology and FISH report and endoscopic finding 10.Report the result According to Miami-criteria 2009, the Criteria for malignant biliary stricture from CholangioFlex are one of the followings; Thick branching bands (>20 microns) Dark clumps or glands (usually measuring > 60 microns) Bright and tortuous vessels Follow up The patients who are diagnosed malignant biliary obstruction will be treated as standard management The patients who are not diagnosed malignant biliary obstruction will be followed up every 3 months for 1 year The gold standard is pathology or clinical of malignancy including evidence of metastasis. Statistical analysis Sensitivity, specificity, negative predictive value(NPV), positive predictive value(PPV) and accuracy by McNemar's test Ethical considerations There is not a clearly evidence about the significant serious side effect of fluorescein injection. If the patients have side effects during the research, the procedure will be terminated and the patients will be in the responsibility of all investigators. Expected benefit and application Increase rate of malignant biliary stricture diagnosis by using CholangioFlex and/or FISH test Decrease the mortality rate of malignant biliary stricture

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

Conditions
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Malignant Biliary Strictures

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CholangioFlex and Fluorescent in situ Hybridization(FISH)<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Increasing the detection rate of malignant biliary stricture diagnosis by using CholangioFlex (Cofocal) and/or FISH test | 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. | up to 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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