Clinical trial · Interventional
Mid-Atlantic Research Group Single-Operator Cholangioscopic Assessment of Biliary Strictures
NCT02615210CI-TRIAL-00071837SOCABSterminatedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Difficulty with contracting
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Biliary Tract Neoplasms | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SOC-directed biopsies using the SpyGlass System | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Standard
- description
- Standard of care biopsies with optional SOC-directed biopsy afterwards
- type
- EXPERIMENTAL
- label
- Study
- description
- SOC-directed biopsies using the SpyGlass System plus standard of care biopsies
- interventionNames
- Device: SOC-directed biopsies using the SpyGlass System
Primary outcomes (1)
- measure
- Number of malignant diagnoses across hree-sample techniques (Spy bite, forceps biopsy, brushings)
- timeFrame
- 72 Hours
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
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
References
Publications (15)
- BACKGROUNDLee 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. PMID 7733076
- BACKGROUNDGlasbrenner 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. PMID 10604612
- BACKGROUNDKipp 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. PMID 15330900
- BACKGROUNDCote 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. PMID 21554986
- BACKGROUNDDraganov 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. PMID 22248602
- BACKGROUNDde 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. PMID 12872082
- BACKGROUNDFogel 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.