Biliary Tract NeoplasmsSOCABSNCT02615210
Mid-Atlantic Research Group Single-Operator Cholangioscopic Assessment of Biliary Strictures
A study testing SOC-directed biopsies using the SpyGlass System in people with Biliary Tract Neoplasms, run by Temple University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Biliary Tract Neoplasms
- What is being tested?
- SOC-directed biopsies using the SpyGlass System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- No sites listed yet
- Study dates
- Nov 2015to Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
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.
Read the 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.
- Conditions
- Biliary Tract Neoplasms
- Being tested
- SOC-directed biopsies using the SpyGlass System
- Medical subject headings
- Biliary Tract Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SOC-directed biopsies using the SpyGlass SystemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard | No intervention | Standard of care biopsies with optional SOC-directed biopsy afterwards |
| Study | Experimental | SOC-directed biopsies using the SpyGlass System plus standard of care biopsies Receives: Device: SOC-directed biopsies using the SpyGlass System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 72 Hours
Secondary outcomes (3)
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
Measured: 1 year
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
Measured: 2 hours
Time from procedure to the initiation of treatment (in cases of malignancy)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2015 (estimated)
- Study startNov 2015
- Primary completionNov 2017
- Study completionNov 2018
Why it stopped: Difficulty with contracting
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Biliary Tract NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Temple University
- Sponsor type
- University, hospital or other
- Collaborators
- Thomas Jefferson University, University of Pennsylvania, University of Pittsburgh Medical Center, Geisinger Clinic, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Responsible party
- Sponsor
- Investigators
- Jennifre L Maranki, M.D., Principal investigator, Temple University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02615210
- Sponsor's protocol ID
- 23154
- Acronym
- SOCABS
- Status last verified
- Nov 2023
- First submitted
- 22 Sep 2015
- Last updated
- 30 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 7733076Glasbrenner 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.
PubMed 10604612Kipp 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.
PubMed 15330900Cote 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.
PubMed 21554986Draganov 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.
PubMed 22248602de 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.
PubMed 12872082Fogel 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.
PubMed 16377319de 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.
PubMed 12397282De 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.
PubMed 12297773Weilert 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.
PubMed 24559784Chen 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.
PubMed 17466202Draganov 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.
PubMed 21419408Chen 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.
PubMed 21762903Ramchandani 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.
PubMed 21737076Siddiqui 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.
PubMed 22178463
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mid-Atlantic Research Group Single-Operator Cholangioscopic Assessment of Biliary Strictures
- ClinicalTrials.gov ID
- NCT02615210
- Acronym / sponsor ID
- SOCABS / 23154
- Conditions
- Biliary Tract Neoplasms
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty with contracting
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Temple UniversityUniversity, hospital or other
- Collaborators
- Thomas Jefferson University, University of Pennsylvania, University of Pittsburgh Medical Center, Geisinger Clinic, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Study start
- Nov 2015 (actual)
- Primary completion
- Nov 2017 (actual)
- Study completion
- Nov 2018 (actual)
- First posted
- 26 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard | No intervention | –Standard of care biopsies with optional SOC-directed biopsy afterwards |
| Study | Experimental | Device: SOC-directed biopsies using the SpyGlass SystemSOC-directed biopsies using the SpyGlass System plus standard of care biopsies |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SOC-directed biopsies using the SpyGlass SystemThe 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. | Device | Study |
Primary outcome
Number of malignant diagnoses across hree-sample techniques (Spy bite, forceps biopsy, brushings)
Time frame: 72 Hours
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
3 secondary outcomes
Number of patients who receive additional diagnostic studies without receiving a cancer diagnosis
Time frame: 1 year
Endoscopic Satisfaction with SOC-directed biopsy
Time frame: 2 hours
Time from procedure to the initiation of treatment (in cases of malignancy)
Time frame: 1 year
Results and safety
The study was stopped early (reason given: Difficulty with contracting). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2023.
- Background: PubMed 7733076Lee 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.
- Background: PubMed 10604612Glasbrenner 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.
- Background: PubMed 15330900Kipp 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.
- Background: PubMed 21554986Cote 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.
- Background: PubMed 22248602Draganov 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.
- Background: PubMed 12872082de 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.
- Background: PubMed 16377319Fogel 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.
- Background: PubMed 12397282de 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.
- Background: PubMed 12297773De 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.
- Background: PubMed 24559784Weilert 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.
- Background: PubMed 17466202Chen 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.
- Background: PubMed 21419408Draganov 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifre L Maranki, M.D. principal investigator
Temple University
Questions about this trial
What is this clinical trial studying?
A study testing SOC-directed biopsies using the SpyGlass System in people with Biliary Tract Neoplasms, run by Temple University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Difficulty with contracting). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of malignant diagnoses across hree-sample techniques (Spy bite, forceps biopsy, brushings) (time frame: 72 Hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02615210, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2023.