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

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.

Study Overview

• Status: Unknown
• Conditions: Biliary Strictures
• Intervention / Treatment: Procedure: Multimodal tissue-sampling methods before and after stricture dilation

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Diagnostic accuracy of multimodal tissue-sampling before and after dilation	Six months

Secondary Outcome Measures

Outcome Measure	Time Frame
Diagnostic accuracy of individual tissue-sampling method	Six months

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Principal Investigator: Hsiu-Po Wang, Dr., National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start: December 1, 2015
• Primary Completion (Anticipated): June 1, 2016
• Study Completion (Anticipated): December 1, 2016

Study Registration Dates

• First Submitted: May 31, 2015
• First Submitted That Met QC Criteria: June 3, 2015
• First Posted (Estimate): June 8, 2015

Study Record Updates

• Last Update Posted (Estimate): December 18, 2015
• Last Update Submitted That Met QC Criteria: December 17, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathological Conditions, Anatomical; Biliary Tract Diseases; Bile Duct Diseases; Constriction, Pathologic; Cholestasis
• Other Study ID Numbers: 201406071RINA