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Comparison of Diagnostic Accuracy Before or After Stricture Dilation in Biliary Stricture

This study is not yet open for participant recruitment.
Verified December 2015 by National Taiwan University Hospital
Sponsor:
ClinicalTrials.gov Identifier:
NCT02465229
First Posted: June 8, 2015
Last Update Posted: December 18, 2015
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
National Taiwan University Hospital
  Purpose

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 Intervention
Biliary Strictures Procedure: Multimodal tissue-sampling methods before and after stricture dilation

Study Type: Interventional
Study Design: 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

Further study details as provided by National Taiwan University Hospital:

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

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

Estimated Enrollment: 60
Study Start Date: December 2015
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Information from the National Library of Medicine

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

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT02465229


Contacts
Contact: Hsiu-Po Wang, Dr. +886-2-23123456 ext 65695 wanghp@ntu.edu.tw
Contact: Wei-Chih Liao, Dr. +886-2-23123456 ext 63356 david.ntuh@gmail.com

Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Hsiu-Po Wang, Dr. National Taiwan University Hospital
  More Information

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT02465229     History of Changes
Other Study ID Numbers: 201406071RINA
First Submitted: May 31, 2015
First Posted: June 8, 2015
Last Update Posted: December 18, 2015
Last Verified: December 2015

Additional relevant MeSH terms:
Constriction, Pathologic
Cholestasis
Pathological Conditions, Anatomical
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases