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
About this trial
This is an interventional diagnostic trial for Biliary Strictures
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
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
NCT ID
NCT02465229
First Posted
May 31, 2015
Last Updated
December 17, 2015
Sponsor
National Taiwan University Hospital
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
Learn more about this trial
Comparison of Diagnostic Accuracy Before or After Stricture Dilation in Biliary Stricture
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