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Trial record 38 of 82 for:    Recruiting, Not yet recruiting, Available Studies | "Cholestasis"

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

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ClinicalTrials.gov Identifier: NCT03140007
Recruitment Status : Not yet recruiting
First Posted : May 4, 2017
Last Update Posted : May 8, 2017
Sponsor:
Collaborators:
Prince of Wales Hospital, Shatin, Hong Kong
Evangelisches Krankenhaus Düsseldorf
Information provided by (Responsible Party):
Mohan Ramchandani, Asian Institute of Gastroenterology, India

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.

Condition or disease Intervention/treatment Phase
Cholangiocarcinoma Biliary Stricture Device: single operator cholangioscopy Device: ERCP guided brushing and biopsy Not Applicable

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: prospective, multi-center, randomized controlled, post market study
Masking: Single (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
Estimated Study Start Date : June 15, 2017
Estimated Primary Completion Date : February 15, 2018
Estimated Study Completion Date : June 15, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy
U.S. FDA Resources

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. 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 :
  1. 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.

  2. 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

  3. 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

  4. 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

  5. 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

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

  7. 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

  8. 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.



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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Mohan Ramchandani, Consultant Gastroenterologist, Asian Institute of Gastroenterology, India
ClinicalTrials.gov Identifier: NCT03140007     History of Changes
Other Study ID Numbers: AIG-002
First Posted: May 4, 2017    Key Record Dates
Last Update Posted: May 8, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
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 Mohan Ramchandani, Asian Institute of Gastroenterology, India:
ERCP
cholangioscopy

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