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

Primary Purpose

Biliary Strictures

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Multimodal tissue-sampling methods before and after stricture dilation
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Biliary Strictures

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Diagnostic methods of indeterminate biliary stricture

    Arm Description

    Outcomes

    Primary Outcome Measures

    Diagnostic accuracy of multimodal tissue-sampling before and after dilation

    Secondary Outcome Measures

    Diagnostic accuracy of individual tissue-sampling method

    Full Information

    First Posted
    May 31, 2015
    Last Updated
    December 17, 2015
    Sponsor
    National Taiwan University Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02465229
    Brief Title
    Comparison of Diagnostic Accuracy Before or After Stricture Dilation in Biliary Stricture
    Official Title
    Comparison of Stricture Dilation Before or After Multimodal Tissue-sampling for the Diagnosis of Malignant Biliary Stricture: a Prospective Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2015
    Overall Recruitment Status
    Unknown status
    Study Start Date
    December 2015 (undefined)
    Primary Completion Date
    June 2016 (Anticipated)
    Study Completion Date
    December 2016 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    National Taiwan University Hospital

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Biliary Strictures

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Diagnostic methods of indeterminate biliary stricture
    Arm Type
    Experimental
    Intervention Type
    Procedure
    Intervention Name(s)
    Multimodal tissue-sampling methods before and after stricture dilation
    Intervention Description
    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 Measure Information:
    Title
    Diagnostic accuracy of multimodal tissue-sampling before and after dilation
    Time Frame
    Six months
    Secondary Outcome Measure Information:
    Title
    Diagnostic accuracy of individual tissue-sampling method
    Time Frame
    Six months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Hsiu-Po Wang, Dr.
    Phone
    +886-2-23123456
    Ext
    65695
    Email
    wanghp@ntu.edu.tw
    First Name & Middle Initial & Last Name or Official Title & Degree
    Wei-Chih Liao, Dr.
    Phone
    +886-2-23123456
    Ext
    63356
    Email
    david.ntuh@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Hsiu-Po Wang, Dr.
    Organizational Affiliation
    National Taiwan University Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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

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