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Completed

NCT Number: NCT01815619

Comparison of On-Site Versus Off-Site Evaluation of Cholangioscopy-Guided Biopsies of the Bile Duct

This study will test two different methods for processing biopsy specimens taken from the bile duct. Patient;s who are asked to participate int his study have a stricture in the bile duct that needs a single operator cholangioscopy-guided biopsies during endoscopic retrograde cholangiopancreatography (ERCP) so that a diagnosis can be made. Standard of care includes performing single operator cholangioscopy-guided biopsies in the bile duct and sending the tissue to the lab for testing to make a diagnosis. Using this method the investigators can establish a diagnosis only about 50% of the time. The investigators believe that if a cytopathologist is available in the endoscopy suite during the procedure to evaluate the biopsy specimens onsite, the investigators can improve the diagnostic accuracy. The purpose of this study is to compare two methods for processing biopsies obtained from the bile duct (Onsite vs. Offsite).

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Key information

Conditions

Bile Duct Stricture

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

AdventHealth Orlando

Orlando, Florida, 32803, United States

About this study

The diagnostic accuracy rate of single operator cholangioscopy-guided biopsy is only 50%. This translates to the need for performing repeat procedures to establish a diagnosis and therefore delays patient treatment. The biopsy specimen obtained at cholangioscopy are usually processed offsite in the pathology lab. We believe that if a pathologist can assess the tissue sample during the procedure itself (onsite) and provide feedback, the diagnostic accuracy rate will improve. This translates to better (faster) diagnosis and early treatment. Therefore, we will be comparing onsite versus offsite evaluation of bile duct biopsy specimens to determine which method yields a better diagnosis.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age > 18 years
  • Suspected biliary stricture

Exclusion criteria

  • Age < 18 years
  • Pregnancy
  • Altered surgical anatomy
  • Irreversible elevation in INR > 1.5 or low platelet count < 50,000

Treatment and study plan

on-site specimen evaluation

Other

The specimen will be evaluated on-site by a cytopathologist during the procedure to render a diagnosis

off-site specimen evaluation

Other

The specimen will be evaluated off-site by a cytopathologist

Primary outcomes

  1. Diagnostic accuracy of cholangioscopy-directed biopsies of bile duct strictures

    Time frame: up to18 months

    The primary endpoint of the study is to compare the diagnostic accuracy rates between two different methods used for processing specimens obtained from the bile duct.

Secondary outcomes

  1. Specimen evaluation

    Time frame: up to18 months

    The secondary endpoint of the study is for specimen evaluation results deemed as malignant; benign; suspicious; atypical, or non-diagnostic.

  2. Operating characteristics

    Time frame: up to18 months

    The secondary endpoint of the study is to assess the operating characteristics through review of the sensitivity, specificity, negative predictive value and positive predictive value between the on-site group and the off-site group.

  3. Costs difference between the onsite and offsite procedures

    Time frame: up to 18 months

    The secondary endpoint of the study is to review and compare total costs of the onsite group in comparison to the total costs of the off-site group.

  4. Number of biopsies to achieve diagnosis

    Time frame: up to 18 months

    The secondary endpoint of the study is to compare between on-site and off-site specimen for the number of biopsies to achieve diagnosis

Sponsors and collaborators

Lead sponsor

AdventHealth

Other

Collaborators

  • University of Alabama at Birmingham

Registry information

Official study title

Single-operator Cholangioscopy-guided Biopsy of Bile Duct Strictures: Randomized Trial of Evaluation of Specimens (SOCRATES)

Important dates

Study start
2013
Primary completion
2020
Study completion
2020
First posted
Mar 21, 2013
Registry last updated
Aug 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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