Comparison of Diagnostic Accuracy Before or After Stricture Dilation in Biliary Stricture
|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: NCT02465229|
Recruitment Status : Unknown
Verified December 2015 by National Taiwan University Hospital.
Recruitment status was: Not yet recruiting
First Posted : June 8, 2015
Last Update Posted : December 18, 2015
Biliary strictures present a diagnostic and therapeutic challenge to clinicians due to unsatisfied accuracy of sampling modality. The major problem is very difficult to discern malignant from non-malignant strictures, such as patients with primary sclerosing cholangitis (PSC). With the poor prognosis and high mortality rate of advanced stage of hepatopancreaticobiliary malignancies, early and accurate diagnosis impacts patients' outcome and possible surgical candidacy. Therefore, a pre-operative determination of malignancy to help plan appropriate treatment is highly desirable.
Before 2000s, several diagnostic modalities, including laboratory tests, ultrasonography (US), computed tomography (CT) scan, cholangiography by percutaneous transhepatic cholangiography endoscopic (PTC) and endoscopic retrograde cholangiopancreatography (ERCP), and brushing cytology disclosed 13% to 24% false positive rate for suspicious malignant hilar strictures. Compared to recent studies, ERCP brushings still suffer from low sensitivity (41.6% ± 3.2% (99% CI)) and negative predictive value (58.0% ± 3.2% (99% CI)). In order to increase diagnostic accuracy, at least two sampling methods, including brushing cytology, biopsy, and fine-needle aspiration is therefore recommended. One article showed multimodal tissue-sampling (Brushing + Biopsy + Fine-needle aspiration) increased the sensitivity for diagnosis of malignant biliary stricture to 62%. However, no any literature demonstrate the best sequence of combined sampling modalities to yield the highest diagnostic accuracy. Besides, the role of stricture dilation before or after different tissue sampling modality is still uncertain.
In this study, the investigators want to compare stricture dilation before or after multimodal tissue-sampling, including brush cytology, intraductal suction and forceps biopsy for the diagnosis of malignant biliary stricture and also assess which kind of the sequence of combined tissue-sampling modalities could offer the highest diagnostic accuracy.
|Condition or disease||Intervention/treatment||Phase|
|Biliary Strictures||Procedure: Multimodal tissue-sampling methods before and after stricture dilation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Comparison of Stricture Dilation Before or After Multimodal Tissue-sampling for the Diagnosis of Malignant Biliary Stricture: a Prospective Study|
|Study Start Date :||December 2015|
|Estimated Primary Completion Date :||June 2016|
|Estimated Study Completion Date :||December 2016|
|Experimental: Diagnostic methods of indeterminate biliary stricture||
Procedure: Multimodal tissue-sampling methods before and after stricture dilation
Each participant will receive the following tissue-sampling methods in order : 1)intraductal suction, 2)intraductal forceps biopsy, 3)brushing cytology, 4)stricture dilation, 5)intraductal suction, 6)intraductal forceps biopsy and 7)brushing cytology during endoscopic retrograde cholangiopancreatography.
- Diagnostic accuracy of multimodal tissue-sampling before and after dilation [ Time Frame: Six months ]
- Diagnostic accuracy of individual tissue-sampling method [ Time Frame: Six months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02465229
|Contact: Hsiu-Po Wang, Dr.||+886-2-23123456 ext firstname.lastname@example.org|
|Contact: Wei-Chih Liao, Dr.||+886-2-23123456 ext email@example.com|
|Principal Investigator:||Hsiu-Po Wang, Dr.||National Taiwan University Hospital|