Biliary Strictures Clinical Trial
Official title:
Comparison of Stricture Dilation Before or After Multimodal Tissue-sampling for the Diagnosis of Malignant Biliary Stricture: a Prospective Study
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.
n/a
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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