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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. 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
Information provided by (Responsible Party):
National Taiwan University Hospital

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. Diagnostic accuracy of multimodal tissue-sampling before and after dilation [ Time Frame: Six months ]

Secondary Outcome Measures :
  1. Diagnostic accuracy of individual tissue-sampling method [ Time Frame: Six months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Clinically suspicious biliary stricture that required tissue sampling as medically indicated were considered for the study

Exclusion Criteria:

  • Biliary stricture caused by extra-luminal compression, such as pancreatic cancer and lymphadenopathy
  • Contraindication for ERCP study
  • Age younger than 20 years
  • Prior tissue sampling had yielded a diagnosis of malignancy
  • A guidewire could not be passed through the stricture
  • Less than 6-month follow-up was available for patients with negative tissue sampling

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02465229

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Contact: Hsiu-Po Wang, Dr. +886-2-23123456 ext 65695
Contact: Wei-Chih Liao, Dr. +886-2-23123456 ext 63356

Sponsors and Collaborators
National Taiwan University Hospital
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Principal Investigator: Hsiu-Po Wang, Dr. National Taiwan University Hospital
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Responsible Party: National Taiwan University Hospital Identifier: NCT02465229    
Other Study ID Numbers: 201406071RINA
First Posted: June 8, 2015    Key Record Dates
Last Update Posted: December 18, 2015
Last Verified: December 2015
Additional relevant MeSH terms:
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Constriction, Pathologic
Pathological Conditions, Anatomical
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases