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
About this trial
This is an interventional diagnostic trial for Biliary Tract Neoplasms
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
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
NCT ID
NCT02615210
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
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
Learn more about this trial
Mid-Atlantic Research Group Single-Operator Cholangioscopic Assessment of Biliary Strictures
We'll reach out to this number within 24 hrs