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

NCT02465229 | Unknown

• 1 other identifier: 201406071RINA
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Biliary Strictures

Outcome Measures

Primary Outcomes (1)

• Diagnostic accuracy of multimodal tissue-sampling before and after dilation

  Six months

Secondary Outcomes (1)

• Diagnostic accuracy of individual tissue-sampling method

  Six months

Study Arms (1)

Diagnostic methods of indeterminate biliary stricture

EXPERIMENTAL

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

Interventions

Multimodal tissue-sampling methods before and after stricture dilation PROCEDURE

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.

Diagnostic methods of indeterminate biliary stricture

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Officials

• Hsiu-Po Wang, Dr.

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hsiu-Po Wang, Dr.

CONTACT

+886-2-23123456; wanghp@ntu.edu.tw

Wei-Chih Liao, Dr.

CONTACT

+886-2-23123456; david.ntuh@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2015
• First Posted: June 8, 2015
• Study Start: December 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: December 1, 2016
• Last Updated: December 18, 2015

Record last verified: 2015-12