Diagnostic Accuracy of ERCP-guided Versus Cholangioscopy-guided Tissue

Diagnostic Accuracy of ERCP-guided Versus Cholangioscopy-guided Tissue Acquisition in Patients With Indeterminate Biliary Strictures Suspected to be Intrinsic – a Randomized Controlled Study (Cholangioscopy)

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https://clinicaltrials.gov/ct2/show/NCT03140007

Purpose
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.

Condition Intervention
Cholangiocarcinoma
Biliary Stricture
Device: single operator cholangioscopy
Device: ERCP guided brushing and biopsy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:
prospective, multi-center, randomized controlled, post market study
Masking: Participant
Masking Description:
prospective, multi-center, randomized controlled, post market study
Primary Purpose: Other
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

Resource links provided by NLM:

Genetics Home Reference related topics: cholangiocarcinoma
MedlinePlus related topics: Biopsy
U.S. FDA Resources

Further study details as provided by Asian Institute of Gastroenterology, India:

Primary Outcome Measures:
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

Secondary Outcome Measures:
Occurrence and severity of procedure related serious adverse events [ Time Frame: 30 days ]
Occurrence and severity of procedure related serious adverse events from index procedure through 30 days after procedure.

Technical success of procedure [ Time Frame: 30 days ]
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

Additional diagnostic accuracy metrics: Sensitivity, specificity, positive predictive value, negative predictive value. [ Time Frame: 6 months ]
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. [ Time Frame: 6 months ]
Number of patients in whom management plan is altered based on ERCP or cholangioscopy will be determined

Number of patients needed additional diagnostic procedures beyond the index procedure for final diagnosis [ Time Frame: 6 months ]
Need for additional diagnostic procedures beyond the index procedure will be noted

Number of accessories used [ Time Frame: At index procedure. ]
The total number of accessories used during the procedure in both arms will be determined.

Duration of procedure from duodenoscope in to duodenoscope out [ Time Frame: At index procedure ]
Duration of procedure is defined as time from duodenoscope in to duodenoscope out

Correlation between impression of malignancy and cytopathology in the ERCP arm compared to the cholangioscopy arm [ Time Frame: 6 months ]
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.

Estimated Enrollment: 60
Anticipated Study Start Date: June 15, 2017
Estimated Study Completion Date: June 15, 2018
Estimated Primary Completion Date: February 15, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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.
Active Comparator: 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.
Device: 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.

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
Eligibility

Ages Eligible for Study: 18 Years to 75 Years (Adult, Senior)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: Yes
Criteria
Inclusion Criteria:

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
Exclusion Criteria:

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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03140007

Contacts
Contact: Mohan Ramchandani, MD DM 9701335444 ramchandanimohan@gmail.com

Sponsors and Collaborators
Asian Institute of Gastroenterology, India
Prince of Wales Hospital, Shatin, Hong Kong
Evangelisches Krankenhaus Düsseldorf
Investigators
Principal Investigator: Mohan Ramchandani, MD DM Asian institute of gastroenterology
More Information

Responsible Party: Mohan Ramchandani, Consultant Gastroenterologist, Asian Institute of Gastroenterology, India
ClinicalTrials.gov Identifier: NCT03140007 History of Changes
Other Study ID Numbers: AIG-002
Study First Received: April 25, 2017
Last Updated: May 2, 2017
Individual Participant Data
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Asian Institute of Gastroenterology, India:
ERCP
cholangioscopy

Additional relevant MeSH terms:
Cholangiocarcinoma
Constriction, Pathologic
Cholestasis
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Pathological Conditions, Anatomical
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on May 05, 2017