Clinical trial NCT03140007: Diagnostic Accuracy of ERCP-guided Versus Cholangioscopy-guided Tissue Acquisition in Patients With Indeterminate Biliary Strictures Suspected to be Intrinsic .
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cholangiocarcinoma
Biliary Stricture
Keywords: ERCP
cholangioscopy
Lead sponsor: Asian Institute of Gastroenterology, India
Sponsor class: OTHER
Collaborators: name: Prince of Wales Hospital, Shatin, Hong Kong
name: Evangelisches Krankenhaus Düsseldorf
First posted: 2017-05-04
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: prospective, multi-center, randomized controlled, post market study
Primary purpose: OTHER

Brief 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.

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:

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

Eligibility criteria: 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

Primary outcomes:
measure: Diagnostic accuracy of cholangioscopy or cholangiography
timeFrame: 6 Months
Secondary outcomes:
measure: Occurrence and severity of procedure related serious adverse events
timeFrame: 30 days
measure: Technical success of procedure
timeFrame: 30 days
measure: Additional diagnostic accuracy metrics: Sensitivity, specificity, positive predictive value, negative predictive value.
timeFrame: 6 months
measure: Impact of ERCP or cholangioscopy on patient management.
timeFrame: 6 months
measure: Number of patients needed additional diagnostic procedures beyond the index procedure for final diagnosis
timeFrame: 6 months
measure: Number of accessories used
timeFrame: At index procedure.
measure: Duration of procedure from duodenoscope in to duodenoscope out
timeFrame: At index procedure
measure: Correlation between impression of malignancy and cytopathology in the ERCP arm compared to the cholangioscopy arm
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Asian Institute of Gastroenterology
name: Mohan Ramchandani, MD DM
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.