Bile Duct StrictureNCT01815619
Comparison of On-Site Versus Off-Site Evaluation of Cholangioscopy-Guided Biopsies of the Bile Duct
A study testing on-site specimen evaluation and off-site specimen evaluation in people with Bile Duct Stricture, run by AdventHealth at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Bile Duct Stricture
- What is being tested?
- on-site specimen evaluation and off-site specimen evaluation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2013to 25 Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years
- Suspected biliary stricture
Who cannot join
- Age < 18 years
- Pregnancy
- Altered surgical anatomy
- Irreversible elevation in INR > 1.5 or low platelet count < 50,000
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single-operator Cholangioscopy-guided Biopsy of Bile Duct Strictures: Randomized Trial of Evaluation of Specimens (SOCRATES)
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).
Read the detailed description
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.
- Conditions
- Bile Duct Stricture
- Being tested
- on-site specimen evaluation, off-site specimen evaluation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
on-site specimen evaluationOther
The specimen will be evaluated on-site by a cytopathologist during the procedure to render a diagnosis
off-site specimen evaluationOther
The specimen will be evaluated off-site by a cytopathologist
| Study group | Role | What they receive |
|---|---|---|
| on-site evaluation of specimens by cytopathologist | Experimental | The specimen will be evaluated onsite by a cytopathologist during the procedure to render a diagnosis Receives: Other: on-site specimen evaluation |
| off-site specimen evaluation | Active comparator | The specimen will be evaluated offsite by a cytopathologist during the procedure and render a diagnosis Receives: Other: off-site specimen evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy of cholangioscopy-directed biopsies of bile duct strictures
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.
Measured: up to18 months
Secondary outcomes (4)
Specimen evaluation
The secondary endpoint of the study is for specimen evaluation results deemed as malignant; benign; suspicious; atypical, or non-diagnostic.
Measured: up to18 months
Operating characteristics
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.
Measured: up to18 months
Costs difference between the onsite and offsite procedures
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.
Measured: up to 18 months
Number of biopsies to achieve diagnosis
The secondary endpoint of the study is to compare between on-site and off-site specimen for the number of biopsies to achieve diagnosis
Measured: up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2013 (estimated)
- Study startFeb 2013
- Primary completionApr 2020
- Study completion25 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Bile Duct StrictureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- AdventHealth
- Sponsor type
- University, hospital or other
- Collaborators
- University of Alabama at Birmingham
- Responsible party
- Sponsor
- Investigators
- Shyam Varadarajulu, MD, Principal investigator, AdventHealth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01815619
- Sponsor's protocol ID
- 409832
- Status last verified
- Aug 2023
- First submitted
- 26 Feb 2013
- Last updated
- 3 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Bang JY, Navaneethan U, Hasan M, Sutton B, Hawes R, Varadarajulu S. Optimizing Outcomes of Single-Operator Cholangioscopy-Guided Biopsies Based on a Randomized Trial. Clin Gastroenterol Hepatol. 2020 Feb;18(2):441-448.e1. doi: 10.1016/j.cgh.2019.07.035. Epub 2019 Jul 24.
PubMed 31351135Navaneethan U, Hasan MK, Kommaraju K, Zhu X, Hebert-Magee S, Hawes RH, Vargo JJ, Varadarajulu S, Parsi MA. Digital, single-operator cholangiopancreatoscopy in the diagnosis and management of pancreatobiliary disorders: a multicenter clinical experience (with video). Gastrointest Endosc. 2016 Oct;84(4):649-55. doi: 10.1016/j.gie.2016.03.789. Epub 2016 Mar 16.
PubMed 26995690
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-operator Cholangioscopy-guided Biopsy of Bile Duct Strictures: Randomized Trial of Evaluation of Specimens (SOCRATES)
- ClinicalTrials.gov ID
- NCT01815619
- Acronym / sponsor ID
- 409832
- Conditions
- Bile Duct Stricture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- AdventHealthUniversity, hospital or other
- Collaborators
- University of Alabama at Birmingham
- Study start
- Feb 2013
- Primary completion
- Apr 2020 (actual)
- Study completion
- 25 Aug 2020 (actual)
- First posted
- 21 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| on-site evaluation of specimens by cytopathologist | Experimental | Other: on-site specimen evaluationThe specimen will be evaluated onsite by a cytopathologist during the procedure to render a diagnosis |
| off-site specimen evaluation | Active comparator | Other: off-site specimen evaluationThe specimen will be evaluated offsite by a cytopathologist during the procedure and render a diagnosis |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age > 18 years
- Suspected biliary stricture
Key exclusion criteria (4 listed)
- Age < 18 years
- Pregnancy
- Altered surgical anatomy
- Irreversible elevation in INR > 1.5 or low platelet count < 50,000
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| on-site specimen evaluationThe specimen will be evaluated on-site by a cytopathologist during the procedure to render a diagnosis | Other | on-site evaluation of specimens by cytopathologist |
| off-site specimen evaluationThe specimen will be evaluated off-site by a cytopathologist | Other | off-site specimen evaluation |
Primary outcome
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.
4 secondary outcomes
Specimen evaluation
Time frame: up to18 months
Operating characteristics
Time frame: up to18 months
Costs difference between the onsite and offsite procedures
Time frame: up to 18 months
Number of biopsies to achieve diagnosis
Time frame: up to 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2023.
- Derived from this study: PubMed 31351135Bang JY, Navaneethan U, Hasan M, Sutton B, Hawes R, Varadarajulu S. Optimizing Outcomes of Single-Operator Cholangioscopy-Guided Biopsies Based on a Randomized Trial. Clin Gastroenterol Hepatol. 2020 Feb;18(2):441-448.e1. doi: 10.1016/j.cgh.2019.07.035. Epub 2019 Jul 24.
- Derived from this study: PubMed 26995690Navaneethan U, Hasan MK, Kommaraju K, Zhu X, Hebert-Magee S, Hawes RH, Vargo JJ, Varadarajulu S, Parsi MA. Digital, single-operator cholangiopancreatoscopy in the diagnosis and management of pancreatobiliary disorders: a multicenter clinical experience (with video). Gastrointest Endosc. 2016 Oct;84(4):649-55. doi: 10.1016/j.gie.2016.03.789. Epub 2016 Mar 16.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shyam Varadarajulu, MD principal investigator
AdventHealth
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing on-site specimen evaluation and off-site specimen evaluation in people with Bile Duct Stricture, run by AdventHealth at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy of cholangioscopy-directed biopsies of bile duct strictures (time frame: up to18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01815619, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2023.