CholangiocarcinomaCholangioscopyNCT03140007
Diagnostic Accuracy of ERCP-guided Versus Cholangioscopy-guided Tissue Acquisition in Patients With Indeterminate Biliary Strictures Suspected to be Intrinsic .
A study testing single operator cholangioscopy and ERCP guided brushing and biopsy in people with Cholangiocarcinoma and Biliary Stricture, run by Asian Institute of Gastroenterology, India.
Trial summary
Primary Objective: To assess the diagnostic accuracy of cholangioscopy-based assessment using SpyDS technology compared to cholangiography-based assessment using ERCP-guided biopsy and brushing in patients with indeterminate biliary strictures in the setting of cholangiocarcinoma. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Cholangiocarcinoma, Biliary Stricture
- What is being tested?
- single operator cholangioscopy and ERCP guided brushing and biopsy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 15 Jun 2017to 15 Jun 2018
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 or older.
- Willing and able to comply with the study procedures and provide written informed consent to participate in the study
- Biliary obstructive symptoms
- Indeterminate biliary stricture suspected to be intrinsic based on prior imaging
Who cannot join
- Contraindications for endoscopic techniques
- Prior ERCP for assessment of indeterminate biliary stricture
- Pancreatic head mass identified on prior non-invasive imaging and thought to be the cause of the biliary obstructive symptoms
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Diagnostic Accuracy of ERCP-guided Versus Cholangioscopy-guided Tissue Acquisition in Patients With Indeterminate Biliary Strictures Suspected to be Intrinsic - a Randomized Controlled Study
Primary Objective: To assess the diagnostic accuracy of cholangioscopy-based assessment using SpyDS technology compared to cholangiography-based assessment using ERCP-guided biopsy and brushing in patients with indeterminate biliary strictures in the setting of cholangiocarcinoma.
Read the detailed description
Study Design : Prospective,multi-center, randomized controlled, Post market Study (PMS)
Two groups:
- Control arm - ERCP arm: ERCP impression and ERCP-guided brushing and biopsy
- Study arm - Cholangioscopy arm: SpyDS impression and SpyDS-guided SpyBite biopsy Randomization 1:1 ratio. Primary Endpoint: Diagnostic accuracy of cholangioscopy or cholangiography assessed at 6 months after initial ERCP procedure
- Malignancy will be determined by cytology or histology on tissue sampling during the index procedure, or from other tissue acquisition or surgical specimen histopathology up to 6 months after the index procedure.
- Overall diagnostic accuracy.
- The assessed strictures will be considered benign if there was no confirmation of malignancy by 6 months after the index procedure.
- Overall diagnostic accuracy will be assessed for
- ERCP impression of malignancy
- ERCP-guided brushing and biopsies separately and combined*
- SpyDS impression of malignancy
- SpyBite biopsies
- In case of discordant results, the following will be followed for the combined pathology/cytology measure:
- If at least one is malignancy, then combine metric is malignant
- If both are benign or one is benign and one is non-diagnostic, then combined metric is benign
- If both are non-diagnostic, then combined metric is non-diagnostic
Secondary Endpoints:
- Occurrence and severity of procedure related serious adverse events from index procedure through 30 days after procedure. Hospitalization and ICU admissions
- Technical success of procedure defined as ability to collect tissue deemed adequate for cytology or histology. Indeterminate or equivocal or atypical or non-conclusive cytology or histology will be considered failures to this endpoint.
- Correlation between impression of malignancy and cytopathology in the ERCP arm compared to the Cholangioscopy arm.
- Additional diagnostic accuracy metrics: Sensitivity, specificity, positive predictive value, negative predictive value. The assessed strictures will be considered benign if there was no confirmation of malignancy by 6 months after the index procedure.
- Impact of ERCP or cholangioscopy on patient management.
- Need for additional diagnostic procedures beyond the index procedure.
- Procedural measures: Type and number of devices used,
- Duration of procedure from duodenoscope in to duodenoscope out
- Conditions
- Cholangiocarcinoma, Biliary Stricture
- Being tested
- single operator cholangioscopy, ERCP guided brushing and biopsy
- Keywords
- ERCP, cholangioscopy
- Medical subject headings
- Cholangiocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
single operator cholangioscopyDevice
If patient is randomized to the Study arm, then the procedure will consist of the following in order: Cannulation and sphincterotomy per standard of practice. POCS with recording of POCS-based impression of malignancy (yes/no/indeterminate). POCS will be performed using the Spy DS system. POCS-guided biopsies will be collected, consisting of 6 macroscopically visible biopsies. The POCS-guided biopsy forceps will be the SpyBite forceps.
ERCP guided brushing and biopsyDevice
- If patients are randomized to the Control arm, then they will undergo an ERCP. ERCP-based impression of malignancy (yes/no/indeterminate) will be recorded. ERCP-guided brushing and ERCP-guided biopsy will be performed.
| Study group | Role | What they receive |
|---|---|---|
| Control arm - ERCP arm | Other | Control arm- If a patient is randomized to the Control arm, then the procedure will consist of the following: ERC with recording of ERC-based impression of malignancy .ERC-guided biopsies will be collected, consisting of 6 macroscopically visible biopsies. The biopsy forceps / brush will be selected per investigator preference. ERC-guided brushing will be performed, consisting of 10 through-and-fro passes through the target lesion. After this a biliary stent will be placed under ERC-guidance if needed. A biliary sphincterotomy will be performed as needed Receives: Device: ERCP guided brushing and biopsy |
| Study arm - cholangioscopy arm | Active comparator | If patient is randomized to the Study arm, then the procedure will consist of the following in order: Cannulation and sphincterotomy per standard of practice. POCS with recording of POCS-based impression of malignancy (yes/no/indeterminate). POCS will be performed using the Spy DS system. POCS-guided biopsies will be collected, consisting of 6 macroscopically visible biopsies. The POCS-guided biopsy forceps will be the SpyBite forceps. Receives: Device: single operator cholangioscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy of cholangioscopy or cholangiography
Malignancy will be determined by cytology or histology on tissue sampling during the index procedure, or from other tissue acquisition or surgical specimen histopathology up to 6 months after the index procedure.The assessed strictures will be considered benign if there was no confirmation of malignancy by 6 months after the index procedure. • Overall diagnostic accuracy will be assessed for ERCP impression of malignancy, ERCP-guided brushing and biopsies separately and combined, SpyDS impression of malignancy and SpyBite biopsies
Measured: 6 Months
Secondary outcomes (8)
Occurrence and severity of procedure related serious adverse events
Occurrence and severity of procedure related serious adverse events from index procedure through 30 days after procedure.
Measured: 30 days
Technical success of procedure
Technical success of procedure defined as ability to collect tissue deemed adequate for cytology or histology. Indeterminate or equivocal or atypical or non-conclusive cytology or histology will be considered failures to this endpoint
Measured: 30 days
Additional diagnostic accuracy metrics: Sensitivity, specificity, positive predictive value, negative predictive value.
Additional diagnostic accuracy metrics: Sensitivity, specificity, positive predictive value, negative predictive value. The assessed strictures will be considered benign if there was no confirmation of malignancy by 6 months after the index procedure
Measured: 6 months
Impact of ERCP or cholangioscopy on patient management.
Number of patients in whom management plan is altered based on ERCP or cholangioscopy will be determined
Measured: 6 months
Number of patients needed additional diagnostic procedures beyond the index procedure for final diagnosis
Need for additional diagnostic procedures beyond the index procedure will be noted
Measured: 6 months
Number of accessories used
The total number of accessories used during the procedure in both arms will be determined.
Measured: At index procedure.
Duration of procedure from duodenoscope in to duodenoscope out
Duration of procedure is defined as time from duodenoscope in to duodenoscope out
Measured: At index procedure
Correlation between impression of malignancy and cytopathology in the ERCP arm compared to the cholangioscopy arm
Number of participants will be compared for outcome of visual impression ( benign/ malignant disease) on ERCP or cholangioscopy with final out come of cytopathology in both arms.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2017
- Study start15 Jun 2017 (estimated)
- Primary completion15 Feb 2018 (estimated)
- Study completion15 Jun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CholangiocarcinomaStudies of the same condition, open and under way.
- More trials run by Asian Institute of Gastroenterology, IndiaThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- prospective, multi-center, randomized controlled, post market study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asian Institute of Gastroenterology, India
- Sponsor type
- University, hospital or other
- Collaborators
- Prince of Wales Hospital, Shatin, Hong Kong, Evangelisches Krankenhaus Düsseldorf
- Responsible party
- Principal investigator, Mohan Ramchandani, Asian Institute of Gastroenterology, India
- Investigators
- Mohan Ramchandani, MD DM, Principal investigator, Asian Institute of Gastroenterology, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03140007
- Sponsor's protocol ID
- AIG-002
- Acronym
- Cholangioscopy
- Status last verified
- May 2017
- First submitted
- 25 Apr 2017
- Last updated
- 8 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gerges C, Beyna T, Tang RSY, Bahin F, Lau JYW, van Geenen E, Neuhaus H, Nageshwar Reddy D, Ramchandani M. Digital single-operator peroral cholangioscopy-guided biopsy sampling versus ERCP-guided brushing for indeterminate biliary strictures: a prospective, randomized, multicenter trial (with video). Gastrointest Endosc. 2020 May;91(5):1105-1113. doi: 10.1016/j.gie.2019.11.025. Epub 2019 Nov 25.
PubMed 31778656
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Accuracy of ERCP-guided Versus Cholangioscopy-guided Tissue Acquisition in Patients With Indeterminate Biliary Strictures Suspected to be Intrinsic - a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT03140007
- Acronym / sponsor ID
- Cholangioscopy / AIG-002
- Conditions
- Cholangiocarcinoma, Biliary Stricture
- Keywords
- ERCP, cholangioscopy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Asian Institute of Gastroenterology, IndiaUniversity, hospital or other
- Collaborators
- Prince of Wales Hospital, Shatin, Hong Kong, Evangelisches Krankenhaus Düsseldorf
- Study start
- 15 Jun 2017 (estimated)
- Primary completion
- 15 Feb 2018 (estimated)
- Study completion
- 15 Jun 2018 (estimated)
- First posted
- 4 May 2017 (actual)
- 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.
Primary Objective: To assess the diagnostic accuracy of cholangioscopy-based assessment using SpyDS technology compared to cholangiography-based assessment using ERCP-guided biopsy and brushing in patients with indeterminate biliary strictures in the setting of cholangiocarcinoma.
Detailed description
Study Design : Prospective,multi-center, randomized controlled, Post market Study (PMS)
Two groups:
- Control arm - ERCP arm: ERCP impression and ERCP-guided brushing and biopsy
- Study arm - Cholangioscopy arm: SpyDS impression and SpyDS-guided SpyBite biopsy Randomization 1:1 ratio. Primary Endpoint: Diagnostic accuracy of cholangioscopy or cholangiography assessed at 6 months after initial ERCP procedure
- Malignancy will be determined by cytology or histology on tissue sampling during the index procedure, or from other tissue acquisition or surgical specimen histopathology up to 6 months after the index procedure.
- Overall diagnostic accuracy.
- The assessed strictures will be considered benign if there was no confirmation of malignancy by 6 months after the index procedure.
- Overall diagnostic accuracy will be assessed for
- ERCP impression of malignancy
- ERCP-guided brushing and biopsies separately and combined*
- SpyDS impression of malignancy
- SpyBite biopsies
- In case of discordant results, the following will be followed for the combined pathology/cytology measure:
- If at least one is malignancy, then combine metric is malignant
- If both are benign or one is benign and one is non-diagnostic, then combined metric is benign
- If both are non-diagnostic, then combined metric is non-diagnostic
Secondary Endpoints:
- Occurrence and severity of procedure related serious adverse events from index procedure through 30 days after procedure. Hospitalization and ICU admissions
- Technical success of procedure defined as ability to collect tissue deemed adequate for cytology or histology. Indeterminate or equivocal or atypical or non-conclusive cytology or histology will be considered failures to this endpoint.
- Correlation between impression of malignancy and cytopathology in the ERCP arm compared to the Cholangioscopy arm.
- Additional diagnostic accuracy metrics: Sensitivity, specificity, positive predictive value, negative predictive value. The assessed strictures will be considered benign if there was no confirmation of malignancy by 6 months after the index procedure.
- Impact of ERCP or cholangioscopy on patient management.
- Need for additional diagnostic procedures beyond the index procedure.
- Procedural measures: Type and number of devices used,
- Duration of procedure from duodenoscope in to duodenoscope out
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- prospective, multi-center, randomized controlled, post market study
| Arm | Type | Receives |
|---|---|---|
| Control arm - ERCP arm | Other | Device: ERCP guided brushing and biopsyControl arm- If a patient is randomized to the Control arm, then the procedure will consist of the following: ERC with recording of ERC-based impression of malignancy .ERC-guided biopsies will be collected, consisting of 6 macroscopically visible biopsies. The biopsy forceps / brush will be selected per investigator preference. ERC-guided brushing will be performed, consisting of 10 through-and-fro passes through the target lesion. After this a biliary stent will be placed under ERC-guidance if needed. A biliary sphincterotomy will be performed as needed |
| Study arm - cholangioscopy arm | Active comparator | Device: single operator cholangioscopyIf patient is randomized to the Study arm, then the procedure will consist of the following in order: Cannulation and sphincterotomy per standard of practice. POCS with recording of POCS-based impression of malignancy (yes/no/indeterminate). POCS will be performed using the Spy DS system. POCS-guided biopsies will be collected, consisting of 6 macroscopically visible biopsies. The POCS-guided biopsy forceps will be the SpyBite forceps. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 or older.
- Willing and able to comply with the study procedures and provide written informed consent to participate in the study
- Biliary obstructive symptoms
- Indeterminate biliary stricture suspected to be intrinsic based on prior imaging
Key exclusion criteria (3 listed)
- Contraindications for endoscopic techniques
- Prior ERCP for assessment of indeterminate biliary stricture
- Pancreatic head mass identified on prior non-invasive imaging and thought to be the cause of the biliary obstructive symptoms
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 |
|---|---|---|
| single operator cholangioscopyIf patient is randomized to the Study arm, then the procedure will consist of the following in order: Cannulation and sphincterotomy per standard of practice. POCS with recording of POCS-based impression of malignancy (yes/no/indeterminate). POCS will be performed using the Spy DS system. POCS-guided biopsies will be collected, consisting of 6 macroscopically visible biopsies. The POCS-guided biopsy forceps will be the SpyBite forceps. | Device | Study arm - cholangioscopy arm |
| ERCP guided brushing and biopsy• If patients are randomized to the Control arm, then they will undergo an ERCP. ERCP-based impression of malignancy (yes/no/indeterminate) will be recorded. ERCP-guided brushing and ERCP-guided biopsy will be performed. | Device | Control arm - ERCP arm |
Primary outcome
Diagnostic accuracy of cholangioscopy or cholangiography
Time frame: 6 Months
Malignancy will be determined by cytology or histology on tissue sampling during the index procedure, or from other tissue acquisition or surgical specimen histopathology up to 6 months after the index procedure.The assessed strictures will be considered benign if there was no confirmation of malignancy by 6 months after the index procedure. • Overall diagnostic accuracy will be assessed for ERCP impression of malignancy, ERCP-guided brushing and biopsies separately and combined, SpyDS impression of malignancy and SpyBite biopsies
8 secondary outcomes
Occurrence and severity of procedure related serious adverse events
Time frame: 30 days
Technical success of procedure
Time frame: 30 days
Additional diagnostic accuracy metrics: Sensitivity, specificity, positive predictive value, negative predictive value.
Time frame: 6 months
Impact of ERCP or cholangioscopy on patient management.
Time frame: 6 months
Number of patients needed additional diagnostic procedures beyond the index procedure for final diagnosis
Time frame: 6 months
Number of accessories used
Time frame: At index procedure.
Duration of procedure from duodenoscope in to duodenoscope out
Time frame: At index procedure
Correlation between impression of malignancy and cytopathology in the ERCP arm compared to the cholangioscopy arm
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2017.
- Derived from this study: PubMed 31778656Gerges C, Beyna T, Tang RSY, Bahin F, Lau JYW, van Geenen E, Neuhaus H, Nageshwar Reddy D, Ramchandani M. Digital single-operator peroral cholangioscopy-guided biopsy sampling versus ERCP-guided brushing for indeterminate biliary strictures: a prospective, randomized, multicenter trial (with video). Gastrointest Endosc. 2020 May;91(5):1105-1113. doi: 10.1016/j.gie.2019.11.025. Epub 2019 Nov 25.
- 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.
Mohan Ramchandani, MD DM principal investigator
Asian Institute of Gastroenterology, India
Questions about this trial
What is this clinical trial studying?
A study testing single operator cholangioscopy and ERCP guided brushing and biopsy in people with Cholangiocarcinoma and Biliary Stricture, run by Asian Institute of Gastroenterology, India.
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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 8 May 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohan Ramchandani, MD DM (9701335444, ramchandanimohan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy of cholangioscopy or cholangiography (time frame: 6 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 NCT03140007, which also lists 1 linked publication.
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 8 May 2017.