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Mid-Atlantic Research Group Single-Operator Cholangioscopic Assessment of Biliary Strictures (SOCABS)

Primary Purpose

Biliary Tract Neoplasms

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
SOC-directed biopsies using the SpyGlass System
Sponsored by
Temple University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Biliary Tract Neoplasms

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age greater than or equal to 18 years
  • Presence of indeterminate biliary strictures with clinical indications for ERCP. Strictures are considered indeterminate when evaluation including cross-sectional imaging is non-diagnostic. Patients who have previously undergone ERCP with sampling will be included, as well as those who have not previously undergone ERCP.
  • Strictures located above the intrapancreatic bile duct
  • The Subject's physician determines and ERCP is clinically indicated
  • Able to provide informed consent

Exclusion Criteria:

  • Prior enrollment in the study or another study evaluating biliary strictures
  • Presence of extrahepatic malignancy or previously-diagnosed hepatocellular carcinoma
  • Pregnancy
  • At-risk populations including prisoners and mentally challenged
  • Unwilling to provide informed consent
  • Medically unfit to undergo ERCP
  • History of liver transplant

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    Standard

    Study

    Arm Description

    Standard of care biopsies with optional SOC-directed biopsy afterwards

    SOC-directed biopsies using the SpyGlass System plus standard of care biopsies

    Outcomes

    Primary Outcome Measures

    Number of malignant diagnoses across hree-sample techniques (Spy bite, forceps biopsy, brushings)
    Accuracy, sensitivity, and specificity of the three-sample technique (Spy bite, forceps biopsy, brushings) compared to the two-sample technique (forceps biopsy and brushing) in differentiating malignant from benign biliary strictures

    Secondary Outcome Measures

    Number of patients who receive additional diagnostic studies without receiving a cancer diagnosis
    Patients who receive a repeat ERCP with sampling, cross-sectional imaging, EUS-FNA, IR-guided biopsies, laparoscopy
    Endoscopic Satisfaction with SOC-directed biopsy
    Endoscopist subjective outcomes using a Likert scale 1-5 Ease of obtaining the biopsies Confidence that the biopsy was taken from the target lesion Confidence that an adequate sample was obtained from the biopsy Clinical impression of malignant disease
    Time from procedure to the initiation of treatment (in cases of malignancy)

    Full Information

    First Posted
    September 22, 2015
    Last Updated
    July 26, 2017
    Sponsor
    Temple University
    Collaborators
    Thomas Jefferson University, University of Pennsylvania, University of Pittsburgh, Geisinger Clinic, McGill University Health Centre/Research Institute of the McGill University Health Centre
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02615210
    Brief Title
    Mid-Atlantic Research Group Single-Operator Cholangioscopic Assessment of Biliary Strictures
    Acronym
    SOCABS
    Official Title
    Mid-Atlantic Research Group Single-Operator Cholangioscopic Assessment of Biliary Strictures
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    November 2015 (undefined)
    Primary Completion Date
    November 2017 (Anticipated)
    Study Completion Date
    November 2018 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Temple University
    Collaborators
    Thomas Jefferson University, University of Pennsylvania, University of Pittsburgh, Geisinger Clinic, McGill University Health Centre/Research Institute of the McGill University Health Centre

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The purpose of this study is to determine if cholangioscopically-directed biopsies provide a higher diagnostic yield for malignancy in the setting of indeterminate biliary strictures when compared to standard means of sampling.
    Detailed Description
    Biliary strictures in the absence of a mass are a clinical challenge, as current accepted means of sampling provide suboptimal accuracy. Both biliary brushings for cytology and fluoroscopically-directed biopsies produce highly-variable results. Endoscopic ultrasound with fine-needle aspiration has also been employed with variable results. An additional modality, using a single-operator cholangioscope during endoscopic retrograde cholangiopancreatography (ERCP) to obtain cholangioscopically-directed biopsies offers promise in increasing the yield of sampling. Initial observational studies have shown an improved diagnostic yield, but the technique has not been tested in a randomized, medical effectiveness study to better characterize its actual clinical impact. We aim to compare the technique of biopsy-on-biopsy derived sampling via single-operator cholangioscopy with standard fluoroscopically-directed biopsies and brushings in a pilot study. We also aim to perform a medical effectiveness study on the early use of single-operator cholangioscopically (SOC) in the evaluation of undiagnosed biliary strictures.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Biliary Tract Neoplasms

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Standard
    Arm Type
    No Intervention
    Arm Description
    Standard of care biopsies with optional SOC-directed biopsy afterwards
    Arm Title
    Study
    Arm Type
    Experimental
    Arm Description
    SOC-directed biopsies using the SpyGlass System plus standard of care biopsies
    Intervention Type
    Device
    Intervention Name(s)
    SOC-directed biopsies using the SpyGlass System
    Intervention Description
    The cholangioscopy procedure with the SpyGlass System is performed by a single operator with the SpyScope Access and Delivery Catheter positioned just below the operating channel of the duodenoscope. SpyBite Biopsy Forceps guided by the SpyScope Catheter are introduced and endoscopic-guided biopsy is taken at the level of the stricture. Target lesions will be identified under direct visualization using the SOC system, and 6-8 bites will be performed with the SpyBite forceps. Once SOC-directed biopsies are obtained, the SOC system will be withdrawn into the working channel of the duodenoscope and removed Patient will be contacted monthly to determine if they have undergone any additional procedures and to record potential adverse events.
    Primary Outcome Measure Information:
    Title
    Number of malignant diagnoses across hree-sample techniques (Spy bite, forceps biopsy, brushings)
    Description
    Accuracy, sensitivity, and specificity of the three-sample technique (Spy bite, forceps biopsy, brushings) compared to the two-sample technique (forceps biopsy and brushing) in differentiating malignant from benign biliary strictures
    Time Frame
    72 Hours
    Secondary Outcome Measure Information:
    Title
    Number of patients who receive additional diagnostic studies without receiving a cancer diagnosis
    Description
    Patients who receive a repeat ERCP with sampling, cross-sectional imaging, EUS-FNA, IR-guided biopsies, laparoscopy
    Time Frame
    1 year
    Title
    Endoscopic Satisfaction with SOC-directed biopsy
    Description
    Endoscopist subjective outcomes using a Likert scale 1-5 Ease of obtaining the biopsies Confidence that the biopsy was taken from the target lesion Confidence that an adequate sample was obtained from the biopsy Clinical impression of malignant disease
    Time Frame
    2 hours
    Title
    Time from procedure to the initiation of treatment (in cases of malignancy)
    Time Frame
    1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    90 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age greater than or equal to 18 years Presence of indeterminate biliary strictures with clinical indications for ERCP. Strictures are considered indeterminate when evaluation including cross-sectional imaging is non-diagnostic. Patients who have previously undergone ERCP with sampling will be included, as well as those who have not previously undergone ERCP. Strictures located above the intrapancreatic bile duct The Subject's physician determines and ERCP is clinically indicated Able to provide informed consent Exclusion Criteria: Prior enrollment in the study or another study evaluating biliary strictures Presence of extrahepatic malignancy or previously-diagnosed hepatocellular carcinoma Pregnancy At-risk populations including prisoners and mentally challenged Unwilling to provide informed consent Medically unfit to undergo ERCP History of liver transplant
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jennifer Maranki, M.D.
    Phone
    215-707-9523
    Email
    jennifer.maranki@tuhs.temple.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jennifre L Maranki, M.D.
    Organizational Affiliation
    Temple University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    7733076
    Citation
    Lee JG, Leung JW, Baillie J, Layfield LJ, Cotton PB. Benign, dysplastic, or malignant--making sense of endoscopic bile duct brush cytology: results in 149 consecutive patients. Am J Gastroenterol. 1995 May;90(5):722-6.
    Results Reference
    background
    PubMed Identifier
    10604612
    Citation
    Glasbrenner B, Ardan M, Boeck W, Preclik G, Moller P, Adler G. Prospective evaluation of brush cytology of biliary strictures during endoscopic retrograde cholangiopancreatography. Endoscopy. 1999 Nov;31(9):712-7. doi: 10.1055/s-1999-73.
    Results Reference
    background
    PubMed Identifier
    15330900
    Citation
    Kipp BR, Stadheim LM, Halling SA, Pochron NL, Harmsen S, Nagorney DM, Sebo TJ, Therneau TM, Gores GJ, de Groen PC, Baron TH, Levy MJ, Halling KC, Roberts LR. A comparison of routine cytology and fluorescence in situ hybridization for the detection of malignant bile duct strictures. Am J Gastroenterol. 2004 Sep;99(9):1675-81. doi: 10.1111/j.1572-0241.2004.30281.x.
    Results Reference
    background
    PubMed Identifier
    21554986
    Citation
    Cote GA, Sherman S. Biliary stricture and negative cytology: what next? Clin Gastroenterol Hepatol. 2011 Sep;9(9):739-43. doi: 10.1016/j.cgh.2011.04.011. Epub 2011 Apr 22. No abstract available.
    Results Reference
    background
    PubMed Identifier
    22248602
    Citation
    Draganov PV, Chauhan S, Wagh MS, Gupte AR, Lin T, Hou W, Forsmark CE. Diagnostic accuracy of conventional and cholangioscopy-guided sampling of indeterminate biliary lesions at the time of ERCP: a prospective, long-term follow-up study. Gastrointest Endosc. 2012 Feb;75(2):347-53. doi: 10.1016/j.gie.2011.09.020.
    Results Reference
    background
    PubMed Identifier
    12872082
    Citation
    de Bellis M, Fogel EL, Sherman S, Watkins JL, Chappo J, Younger C, Cramer H, Lehman GA. Influence of stricture dilation and repeat brushing on the cancer detection rate of brush cytology in the evaluation of malignant biliary obstruction. Gastrointest Endosc. 2003 Aug;58(2):176-82. doi: 10.1067/mge.2003.345.
    Results Reference
    background
    PubMed Identifier
    16377319
    Citation
    Fogel EL, deBellis M, McHenry L, Watkins JL, Chappo J, Cramer H, Schmidt S, Lazzell-Pannell L, Sherman S, Lehman GA. Effectiveness of a new long cytology brush in the evaluation of malignant biliary obstruction: a prospective study. Gastrointest Endosc. 2006 Jan;63(1):71-7. doi: 10.1016/j.gie.2005.08.039.
    Results Reference
    background
    PubMed Identifier
    12397282
    Citation
    de Bellis M, Sherman S, Fogel EL, Cramer H, Chappo J, McHenry L Jr, Watkins JL, Lehman GA. Tissue sampling at ERCP in suspected malignant biliary strictures (Part 2). Gastrointest Endosc. 2002 Nov;56(5):720-30. doi: 10.1067/mge.2002.129219. No abstract available.
    Results Reference
    background
    PubMed Identifier
    12297773
    Citation
    De Bellis M, Sherman S, Fogel EL, Cramer H, Chappo J, McHenry L Jr, Watkins JL, Lehman GA. Tissue sampling at ERCP in suspected malignant biliary strictures (Part 1). Gastrointest Endosc. 2002 Oct;56(4):552-61. doi: 10.1067/mge.2002.128132. No abstract available.
    Results Reference
    background
    PubMed Identifier
    24559784
    Citation
    Weilert F, Bhat YM, Binmoeller KF, Kane S, Jaffee IM, Shaw RE, Cameron R, Hashimoto Y, Shah JN. EUS-FNA is superior to ERCP-based tissue sampling in suspected malignant biliary obstruction: results of a prospective, single-blind, comparative study. Gastrointest Endosc. 2014 Jul;80(1):97-104. doi: 10.1016/j.gie.2013.12.031. Epub 2014 Feb 19.
    Results Reference
    background
    PubMed Identifier
    17466202
    Citation
    Chen YK, Pleskow DK. SpyGlass single-operator peroral cholangiopancreatoscopy system for the diagnosis and therapy of bile-duct disorders: a clinical feasibility study (with video). Gastrointest Endosc. 2007 May;65(6):832-41. doi: 10.1016/j.gie.2007.01.025.
    Results Reference
    background
    PubMed Identifier
    21419408
    Citation
    Draganov PV, Lin T, Chauhan S, Wagh MS, Hou W, Forsmark CE. Prospective evaluation of the clinical utility of ERCP-guided cholangiopancreatoscopy with a new direct visualization system. Gastrointest Endosc. 2011 May;73(5):971-9. doi: 10.1016/j.gie.2011.01.003. Epub 2011 Mar 17.
    Results Reference
    background
    PubMed Identifier
    21762903
    Citation
    Chen YK, Parsi MA, Binmoeller KF, Hawes RH, Pleskow DK, Slivka A, Haluszka O, Petersen BT, Sherman S, Deviere J, Meisner S, Stevens PD, Costamagna G, Ponchon T, Peetermans JA, Neuhaus H. Single-operator cholangioscopy in patients requiring evaluation of bile duct disease or therapy of biliary stones (with videos). Gastrointest Endosc. 2011 Oct;74(4):805-14. doi: 10.1016/j.gie.2011.04.016. Epub 2011 Jul 18.
    Results Reference
    background
    PubMed Identifier
    21737076
    Citation
    Ramchandani M, Reddy DN, Gupta R, Lakhtakia S, Tandan M, Darisetty S, Sekaran A, Rao GV. Role of single-operator peroral cholangioscopy in the diagnosis of indeterminate biliary lesions: a single-center, prospective study. Gastrointest Endosc. 2011 Sep;74(3):511-9. doi: 10.1016/j.gie.2011.04.034. Epub 2011 Jul 7.
    Results Reference
    background
    PubMed Identifier
    22178463
    Citation
    Siddiqui AA, Mehendiratta V, Jackson W, Loren DE, Kowalski TE, Eloubeidi MA. Identification of cholangiocarcinoma by using the Spyglass Spyscope system for peroral cholangioscopy and biopsy collection. Clin Gastroenterol Hepatol. 2012 May;10(5):466-71; quiz e48. doi: 10.1016/j.cgh.2011.12.021. Epub 2011 Dec 16.
    Results Reference
    background

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    Mid-Atlantic Research Group Single-Operator Cholangioscopic Assessment of Biliary Strictures

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