Clinical Parameters | Barakat et al, 2018 | Brewster Gutierrez et al, 2018 | Imanishi et al, 2017 | Mizrahi et al, 2018 | Navaneethan et al, 2016 | Ogura et al, 2017 | Ridtitid et al, 2017 | Shah et al, 2017 | Tanaka et al, 2016 | Wong et al, 2017 | Summary Outcomes |
---|---|---|---|---|---|---|---|---|---|---|---|
Therapeutic sample size | 39; 40 underwent procedure, but only 39 had stones or sludge found requiring treatment | 407 | 8 | 63 | 36 | 22 | 50 | 28 | 8 | 17 | 679 (678 underwent treatment; in 1 case, no stones were found) |
Therapeutic success rate | 39 of 39 (100%) | 396 of 407 (97.3%) | 7 of 8 (87.5%) | 52 of 63 (83%) after first EHL | 35 of 36 (97.2%) | 20 of 22 (90.9%) | 45 of 50 (90%) | 28 of 28 (100%) | 7 of 8 (87.5%)b | 16 of 17 (94.1%) | 645 of 678 (95.1%) |
Success rate of stone/sludge clearance | 39 of 39 (100%) | 396 of 407 (97.3%) | 4 of 4 (100%) | 52 of 63 (83%) after first EHL | 35 of 36 (97.2%) | 13 of 13 (100%) | 45 of 50 (90%) | 28 of 28 (100%) | 3 of 3 (100%) | 16 of 17 (94.1%) | 631 of 660 (95.6%) |
Success of guidewire insertion/passage | NA | NA | 2 of 3 (66.7%) | NA | NA | 5 of 7 (71.4%) | NA | NA | 1 of 2 (50%) | NA | 8 of 12 (66.7%) |
Success rate of migrating stent removal | NA | NA | 1 of 1 (100%) | NA | NA | 2 of 2 (100%) | NA | NA | 3 of 3 (100%) | NA | 6 of 6 (100%) |
Adverse events | 3 of 40 (7.5%) Pancreatitis (2) Bleeding (1) |
Cholangitis (6) Abdominal pain (5) Pancreatitis (1) Bleeding (1) Transient Bacteremia (1) Bile duct perforation (1) | 0 of 8 (0%) | 2 of 126 (1.2%)a Acute pancreatitis and abdominal pain (numbers not specified) | 3 of 105 (2.9%)a Cholangitis (2) Pancreatitis (1) | 1 of 22 (4.5%) Cholangitis (1) | 5 of 50 (10%) Pancreatitis (2) Bleeding (2) Cholangitis (1) | 3 of 108 (2.8%)a Cholangitis (1) Pancreatitis (1) Abdominal Pain (1) | 2 of 26 (7.7%)a Cholangitis (1) Bleeding (1) | 2 of 17 (11.8%) Cholangitis (2) | 36 of 909 (4.0%)a |
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SpyGlass™ DS System Direct Visualisation Systems
The SpyGlass™ DS System enables direct visualisation of the pancreatic and bile ducts, is used to evaluate suspected benign and malignant conditions, and is used for the treatment of difficult stones and strictures.
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SpyGlass™ DS System Direct Visualisation Systems
Figure 1. The SpyGlass DS Direct Visualization System.
Figure 2. Visualization and accurate targeting of complicated biliary stones can be achieved using the SpyGlass DS System.
(a) benign
(b) malignant bile duct strictures.
* Includes diagnostic and therapeutic patients because adverse events were not separated by type of procedure in this study.
** Includes one additional patient not considered therapeutic in the publication because the initial goal was diagnostic. The patient then underwent a therapeutic intervention and therefore was considered in the therapeutic group for this analysis.
N=679
Based on references 13, 15, and 17-24.
References:
- Xu MMK. Recent developments in choledochoscopy: technical and clinical advances. Clin Exp Gastroenterol. 2016;9:119-124.
- Pereira P, Peixoto A, Andrade P, et al. Peroral cholangiopancreatoscopy with the SpyGlass system: what do we know 10 years later. J Gastrointest Liver Dis. 2017;26(2):165-170.
- Moon JH, Choi HJ. The role of direct peroral cholangioscopy using an ultraslim endoscope for biliary lesions: indications, limitations, and complications. Clin Endosc. 2013;46(5):537-539.
- SpyGlass DS System brochure. Marlborough, MA: Boston Scientific Corporation. 2015.
- Kalaitzakis E, Webster GJ. Endoscopic diagnosis of biliary tract disease. Curr Opin Gastroenterol. 2012;28(3):273-279.
- Ponchon T, Genin G, Mitchell R, et al. Methods, indications, and results of percutaneous choledochoscopy: a series of 161 procedures. Ann Surg. 1996;223(1):26-36.
- Navaneethan U, Hasan MK, Lourdusamy V, et al. Single-operator cholangioscopy and targeted biopsies in the diagnosis of indeterminate biliary strictures: a systematic review. Gastrointest Endosc. 2015;82(4):608-614.e2.
- Voaklander R, Kim E, Brown WH, et al. An overview of the evolution of direct cholangioscopy techniques for diagnosis and therapy. Gastroenterol Hepatol. 2016;12(7):433-437.
- SpyGlass DS System Value Analysis. Marlborough, MA: Boston Scientific Corporation. 2017.
- Shah RJ, Neuhaus H, Parsi M, et al. Randomized study of digital single-operator cholangioscope compared to fiberoptic single-operator cholangioscope in a novel cholangioscopy bench model. Endosc Int Open. 2018;6(7):E851-E856.
- Parsi MA. Peroral cholangioscopy in the new millennium. World J Gastroenterol. 2011;17(1):1-6.
- Trikudanathan G, Navaneethan U, Parsi MA. Endoscopic management of difficult common bile duct stones. World J Gastroenterol. 2013;19(2):165-173.
- Wong JC, Tang RS, Teoh AY, et al. Efficacy and safety of novel digital single-operator peroral cholangioscopy-guided laser lithotripsy for complicated biliary stones. Endosc Int Open. 2017;5(1):E54-E58.
- Lee TY, Cheon YK, Choe WH, et al. Direct cholangioscopy-based holmium laser lithotripsy of difficult bile duct stones by using an ultrathin upper endoscope without a separate biliary irrigating catheter. Photomed Laser Surg. 2012;30(1):31-36.
- Brewer Gutierrez O, Bekkali NLH, Raijman I, et al. Efficacy and safety of digital single-operator cholangioscopy for difficult biliary stones. Clin Gastroenterol Hepatol. 2018;16(6):918-926.e1.
- Turowski F, Hügle U, Dormann A, et al. Diagnostic and therapeutic single-operator cholangiopancreatoscopy with SpyGlass DS: results of a multicenter retrospective cohort study. Surg Endosc. 2018;32(9):3981-3988.
- Barakat MT, Girotra M, Choudhary A, et al. A prospective evaluation of radiation-free direct solitary cholangioscopy for the management of choledocholithiasis. Gastrointest Endosc. 2018;87(2):584-589.e1.
- Imanishi M, Ogura T, Kurisu Y, et al. A feasibility study of digital single-operator cholangioscopy for diagnostic and therapeutic procedure (with videos). Medicine (Baltimore). 2017;96(15):e6619.
- Mizrahi M, Khoury T, Wang Y, et al. “Apple Far from the Tree”: comparative effectiveness of fiberoptic single-operator cholangiopancreatoscopy (FSOCP) and digital SOCP (DSOCP). HPB (Oxford). 2018;20(3):285-288.
- Navaneethan U, Hasan MK, Kommaraju K, et al. Digital, single-operator cholangiopancreatoscopy in the diagnosis and management of pancreatobiliary disorders: a multicenter clinical experience (with video). Gastrointest Endosc. 2016;84(4):649-655.
- Ogura T, Imanishi M, Kurisu Y, et al. Prospective evaluation of digital single-operator cholangioscope for diagnostic and therapeutic procedures (with videos). Dig Endosc. 2017;29(7):782-789.
- Ridtitid W, Luangsukrerk T, Angsuwatcharakon P, et al. Uncomplicated common bile duct stone removal guided by cholangioscopy versus conventional endoscopic retrograde cholangiopancreatography. Surg Endosc. 2018;32(6):2704-2712.
- Shah RJ, Raijman I, Brauer B, et al. Performance of a fully disposable, digital, single-operator cholangiopancreatoscope. Endoscopy. 2017;49(07):651-658.
- Tanaka R, Itoi T, Honjo M, et al. New digital cholangiopancreatoscopy for diagnosis and therapy of pancreaticobiliary diseases (with videos). J Hepatobiliary Pancreat Sci. 2016;23(4):220-226.
- Brewer Gutierrez OI, Raijman I, Shah RJ, et al. International multicenter study on digital single operator pancreatoscopy for the management of pancreatic stones. Gastrointest Endosc. 2018;87(6):AB68-AB69.
- Mizrahi M, Bartley A, Cohen J, et al. If at first you do not succeed, spy again! Gastrointest Endosc. 2017;85(5):AB648-AB649.
- Hustak R, Král J, Neumann F, et al. Digital, single-operator cholangiopancreatoscopy in the diagnosis and management of pancreatobiliary disorders: results from the multicenter Czech and Slovak national database. Gastrointest Endosc. 2017;85(5):AB641.
- Luangsukrerk T, Ridtitid W, Angsuwatcharakon P, et al. Outcomes of digital spyglass cholangioscopy (without fluoroscopy) versus conventional endoscopic retrograde cholangiopancreatography for common bile duct stone removal. Gastrointest Endosc. 2017;85(5):AB622-AB623.
- Bekkali NS, Dwyer LK, Direkze S, et al. SpyGlass DS cholangioscopy for difficult stones: early experience of two UK centres. Gastrointestinal Endosc. 2016(1):AB295-AB296.
- Tabibian JH, Visrodia KH, Levy MJ, et al. Advanced endoscopic imaging of indeterminate biliary strictures. World J Gastrointest Endosc. 2015;7(18):1268-1278.
- Ramchandani MK, Goenka MK, Itoi T, et al. Single operator cholangioscopy for the evaluation and diagnosis of indeterminate biliary strictures – results from a large multinational registry. Gastrointest Endosc. 2017;85(5):AB615.
- Tyberg A, Raijman I, Siddiqui A, et al. Digital pancreaticocholangioscopy for mapping of pancreatico-biliary neoplasia: can we alter the surgical resection margin? Gastrointest Endosc. 2017;85(5):AB95-AB96.
- Ogawa T, Ito K, Koshita S, et al. Usefulness of cholangioscopic-guided mapping biopsy using SpyGlass DS for preoperative evaluation of extrahepatic cholangiocarcinoma: a pilot study. Endosc Int Open. 2018;6(2):E199-E204.
- Raijman I, Shah R, Tarnasky PR, et al. Digital single operator cholangiopancreatoscope (DSOP) in the assessment of pancreatic intrapapillary mucinous neoplasia (IPMN). Gastrointest Endosc. 2016;83(5):AB277-AB278.
- Raijman I, Shah R, Tarnasky PR, et al. Digital single operator pancreatoscope (DSOP) in the management of pancreatic disease. Gastrointest Endosc. 2016;83(5):AB277.
- Trindade AJ, Benias PC, Kurupathi P, et al. Digital pancreatoscopy in the evaluation of main duct intraductal papillary mucinous neoplasm: a multicenter study. Endoscopy. 2018;50(11):1095-1098.
- Shah R, Qayed E. Bedside endoscopic retrograde cholangiopancreatography using portable x-ray in acute severe cholangitis. Case Rep Gastrointest Med. 2018;2018:8763671.
- Shaw P, Duncan A, Vouyouka A, et al. Radiation exposure and pregnancy. J Vasc Surg. 2011;53(1 suppl):28S-34S.
- Saumoy M, Schneider Y, Novikov AA, et al. A cost-utility analysis of various endoscopic methods for evaluation of indeterminate biliary strictures. Gastrointest Endosc. 2017;85(5):AB626.
- Deprez PH, Garces Duran R, Moreels T, et al. The economic impact of using single-operator cholangioscopy for the treatment of difficult bile duct stones and diagnosis of indeterminate bile duct strictures. Endoscopy. 2018;50(2):109-118.
- Castle M, Lonon M, Faucher S, et al. Real world use and economic impact of single operator SpyGlass cholangioscopy: a single center analysis of the first 18 months implementation. Gastrointest Endosc. 2018;87(6):AB596.
- Varadarajulu S, Bang JY, Hasan MK, et al. Improving the diagnostic yield of single- operator cholangioscopy-guided biopsy of indeterminate biliary strictures: ROSE to the rescue? (with video). Gastrointest Endosc. 2016;84:681-687.
- Hoffman A, Kiesslich R, Bittinger F, et al. Methylene blue-aided cholangioscopy in patients with biliary strictures: feasibility and outcome analysis. Endoscopy. 2008;40(7):563-571.
- Lee YN, Moon JH, Choi HJ, et al. Direct peroral cholangioscopy for diagnosis of bile duct lesions using an I-SCAN ultraslim endoscope: a pilot study. Endoscopy. 2017;49(7):675-681.
Images provided courtesy of Dr. Raijman.
ENDO- 1141201 -AA
SpyGlass™ DS System Direct Visualisation Systems
An Expanding Suite of Compatible Accessories and Applications
The SpyScopeTM DS II Catheter is compatible with a full suite of diagnostic and therapeutic accessories to enable the management of complex stones and strictures. It may also be a useful tool to help define pre-surgical mapping and to inspect tissue before and after ablation procedures.
Stone Management
The SpyGlass™ DS System combined with a lithotripsy device, such as the Autolith™ Touch System for Electrohydraulic Lithotripsy (EHL), provides the capability to fragment biliary stones under direct visualization and enable a high stone clearance success rate in single session treatments.1
Approximately 10-15% of biliary stone cases are considered difficult and cannot be treated effectively using standard ERCP techniques.2
Direct visualization stone clearance using EHL has been shown to be clinically effective with demonstrated procedural success, with single-session stone clearance rates of 74.5%1.
The SpyGlass Retrieval Basket can be used to capture and remove residual biliary and pancreatic stones and stone fragments visualized with the SpyGlass DS System.
Achieving single session stone clearance and reducing the need for a repeat procedure(s) may deliver greater patient satisfaction and decrease unnecessary procedural costs.
Stricture Management
When used during an ERCP procedure, the SpyGlass DS System enables direct visualization of the bile and pancreatic ducts and can help perform biopsies, diagnose indeterminate strictures, and remove foreign bodies such as migrated biliary and pancreatic plastic stents.
Performing biopsies under direct visualization using the SpyGlass DS System and SpyBite™ Biopsy Forceps (86% sensitivity)3 may enable faster, more accurate diagnosis of malignancies compared to brush cytology (45% sensitivity)4.
NEW SpyBite Max Biopsy Forceps - a design enhancement to the legacy SpyBite Biopsy Forceps - have been shown to acquire more than 2X tissue in an average bite.5
In a prospective study of 289 patients, diagnostic ERCP with cholangioscopy altered patient management in 85% of patients and had high procedural success and high accuracy in helping to diagnose indeterminate strictures.6
The SpyGlass Retrieval Snare is designed to enable efficient capture and removal of foreign bodies in the biliary and pancreatic ducts, such as migrated plastic stents, during an ERCP procedure.
Facilitating Ablation Procedures
When used in conjunction with the Habib™ EndoHPB Bipolar Radiofrequency Ablation Catheter and metal stent placement, the SpyGlass DS System may be a useful tool to help confirm the ablation size and location when used before and after the procedure.
Presurgical Mapping
A recent study examining the role of digital cholangiopancreatoscopy technology in “mapping” the extent of malignant involvement in the biliary or pancreatic ducts before surgical intervention demonstrated, through an analysis of 118 patients, that the surgical plan was altered in 34% of cases when using direct visualization with the SpyGlass DS System.7
* The effectiveness of ablation with the Habib EndoHPB Catheter for use in the treatment of pancreatic or biliary cancer or pancreatic or biliary disease (i.e. improved clinical outcomes) has not been established.
1. Brewer Gutierrez OI, et al. Efficacy and Safety of Digital Single-Operator Cholangioscopy for Difficult Biliary Stones. Clin Gastroenterol Hepatol. 2018 Jun;16(6):918-926.e1.
2. Parsi et al. Endoscopic management of difficult common bile duct stones. World J Gastroenterol 2013; 19(2): 165-173
3. Shah et al. Performance of a fully disposable, digital, single operator cholangiopancreatoscope. Endoscopy 2017; 49: 651–658.
4. Navaneethan U, et al. Comparative effectiveness of biliary brush cytology and intraductal biopsy for detection of malignant biliary strictures: a systematic review and meta-analysis. Gastrointest Endosc. 2015 Jan;81(1):168-76.
5. Data on file.
6. Ramchandani, Mohan K. et al. Tu1412 Single Operator Cholangioscopy for the Evaluation and Diagnosis of Indeterminate Biliary Strictures - Results From a Large Multi-National Registry. Gastrointestinal Endoscopy, Volume 85, Issue 5, AB615.
7. Tyberg A, et al. Digital Pancreaticocholangioscopy for Mapping of Pancreaticobiliary Neoplasia: Can We Alter the Surgical Resection Margin? J Clin Gastroenterol. 2019 Jan;53(1):71-75.
ENDO- 1141101 -AA
All images taken by Boston Scientific. All trademarks are the property of their respective owners. CAUTION: The law restricts these devices to sale by or on the order of a physician. Indications, contraindications, warnings and instructions for use can be found in the product labelling supplied with each device. Information for use only in countries with applicable health authority registrations. This material not intended for use in France. Products shown for INFORMATION purposes only and may not be approved or for sale in certain countries. Please check availability with your local sales representative or customer service.