Diagnostic Accuracy of ERCP-guided Versus Cholangioscopy-guided Tissue Acquisition in Patients With Indeterminate Biliary Strictures Suspected to be Intrinsic .

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-15

Study Completion Date

2018-06-15

Brief Summary

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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.

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Detailed Description

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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:

1. Occurrence and severity of procedure related serious adverse events from index procedure through 30 days after procedure. Hospitalization and ICU admissions
2. 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.
3. Correlation between impression of malignancy and cytopathology in the ERCP arm compared to the Cholangioscopy arm.
4. 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.
5. Impact of ERCP or cholangioscopy on patient management.
6. Need for additional diagnostic procedures beyond the index procedure.
7. Procedural measures: Type and number of devices used,
8. Duration of procedure from duodenoscope in to duodenoscope out

Conditions

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Cholangiocarcinoma Biliary Stricture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

prospective, multi-center, randomized controlled, post market study

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

prospective, multi-center, randomized controlled, post market study

Study Groups

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Control arm - ERCP arm

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

Group Type OTHER

ERCP guided brushing and biopsy

Intervention Type DEVICE

• 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 arm - cholangioscopy arm

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.

Group Type ACTIVE_COMPARATOR

single operator cholangioscopy

Intervention Type DEVICE

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.

Interventions

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single operator cholangioscopy

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.

Intervention Type DEVICE

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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Age 18 or older.
2. Willing and able to comply with the study procedures and provide written informed consent to participate in the study
3. Biliary obstructive symptoms
4. Indeterminate biliary stricture suspected to be intrinsic based on prior imaging

Exclusion Criteria

1. Contraindications for endoscopic techniques
2. Prior ERCP for assessment of indeterminate biliary stricture
3. Pancreatic head mass identified on prior non-invasive imaging and thought to be the cause of the biliary obstructive symptoms

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes