I Spy Biliary and Pancreatic Ducts: The SpyGlass Single ... · ERCP, right upper quadrant...

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PRACTICAL GASTROENTEROLOGY • APRIL 2009 15 INTRODUCTION T his profile summarizes the technical aspects and the preliminary literature related to the use of the SpyGlass Direct Visualization System. This novel technology provides the endoscopist with a direct intraluminal view of the biliary duct system. Consequently, lesions within the biliary tract can be biopsied under direct vision. It also allows for the application of therapeutic devices such as electrohy- draulic lithotripsy (EHL) and holmium laser to frag- ment stones. This technology has utility when imaging limitations of conventional endoscopic retrograde cholangiopancreatography (ERCP) are encountered. It also appears to have overcome many of the limitations of earlier generation choledochoscopes. HISTORICAL PERSPECTIVE For the better part of forty years, biliary duct evaluation via cholangioscopy, in one form or another, has been in use by gastroenterologists. The techniques and technol- ogy through which this has been possible have been under significant scrutiny and constant refinement from its onset. The evolution of peroral cholangioscopy (POCS) is impressive, and has been well documented. The earliest attempts at visualizing biliary anatomy with fiberscopes were only a glimpse of what was to come. Roughly thirty years after the first intra- operative cholangioscopy, the “mother-baby” scope was introduced. Initially a lengthy procedure requiring two specially trained endoscopists, POCS cases often lasted upwards of two hours. In addition, the early scopes were large, cumbersome and fragile. Often their specially designed optical fibers would break from the movement of the duodenoscope alone. Also, the first steering apparatuses were bidirectional as opposed to the four-quadrant steering of standard endoscopes. The initial working channels were some- times less than adequate for biopsy forceps. I Spy Biliary and Pancreatic Ducts: The SpyGlass Single-Operator Peroral Cholangiopancreatoscopy System ENDOSCOPY: OPENING NEW EYES, SERIES #1 Andrew K. Roorda, M.D., Fellow, Section of Digestive Diseases; Justin T. Kupec, M.D., Fellow, Section of Digestive Diseases; Uma Sundaram, M.D., Chief, Section of Digestive Diseases; Department of Medi- cine, West Virginia University School of Medicine, Morgantown, WV. Andrew K. Roorda Justin T. Kupec Uma Sundaram

Transcript of I Spy Biliary and Pancreatic Ducts: The SpyGlass Single ... · ERCP, right upper quadrant...

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INTRODUCTION

T his profile summarizes the technical aspects andthe preliminary literature related to the use of theSpyGlass Direct Visualization System. This

novel technology provides the endoscopist with adirect intraluminal view of the biliary duct system.Consequently, lesions within the biliary tract can bebiopsied under direct vision. It also allows for theapplication of therapeutic devices such as electrohy-draulic lithotripsy (EHL) and holmium laser to frag-ment stones. This technology has utility when imaginglimitations of conventional endoscopic retrogradecholangiopancreatography (ERCP) are encountered. Italso appears to have overcome many of the limitationsof earlier generation choledochoscopes.

HISTORICAL PERSPECTIVE For the better part of forty years, biliary duct evaluationvia cholangioscopy, in one form or another, has been inuse by gastroenterologists. The techniques and technol-ogy through which this has been possible have beenunder significant scrutiny and constant refinement fromits onset. The evolution of peroral cholangioscopy(POCS) is impressive, and has been well documented.

The earliest attempts at visualizing biliaryanatomy with fiberscopes were only a glimpse of whatwas to come. Roughly thirty years after the first intra-operative cholangioscopy, the “mother-baby” scopewas introduced. Initially a lengthy procedure requiringtwo specially trained endoscopists, POCS cases oftenlasted upwards of two hours. In addition, the earlyscopes were large, cumbersome and fragile. Oftentheir specially designed optical fibers would breakfrom the movement of the duodenoscope alone. Also,the first steering apparatuses were bidirectional asopposed to the four-quadrant steering of standardendoscopes. The initial working channels were some-times less than adequate for biopsy forceps.

I Spy Biliary and Pancreatic Ducts:The SpyGlass Single-Operator PeroralCholangiopancreatoscopy System

ENDOSCOPY: OPENING NEW EYES, SERIES #1

Andrew K. Roorda, M.D., Fellow, Section of DigestiveDiseases; Justin T. Kupec, M.D., Fellow, Section ofDigestive Diseases; Uma Sundaram, M.D., Chief,Section of Digestive Diseases; Department of Medi-cine, West Virginia University School of Medicine,Morgantown, WV.

Andrew K. Roorda Justin T. Kupec Uma Sundaram

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The evolution of miniscopes came next. Thesesmaller scopes were more apt to access the commonbile duct (CBD) without papillotomy, and, as technol-ogy allowed the scopes to get smaller, the workingchannels became more useful in therapeutic situations.While not yet perfect (e.g. no separate working chan-nels), the option to move away from the “mother-baby”scope was present, and it was now possible to pass theminiscopes through the duodenoscope (duodenoscopeassisted cholangiopancreatoscopy—DACP). As moretechnology went into the miniscopes, their size becamesmaller, their resolution sharper and their therapeuticapplications broader. Great strides have been madefrom the first miniscope to the advent of the SpyGlassperoral cholangiopancreatoscopy system, not the leastof which are separate working and irrigation channelsas well as four-way maneuvering (1–3).

ERCP has been a proven means of evaluating andtreating a myriad of biliary pathologies. It remains thegold standard for CBD stone removal, therapeuticsphincterotomy and biliary stent placement (for benignor malignant strictures), but often the pathology inquestion during ERCP needs further imaging beyondfluoroscopy. Direct evaluation of the biliary tree nowallows optically guided biopsies, real-time video ofquestionable lesions and a view of previously seenstrictures with the chance of determining whether theyare benign or malignant.

SPYGLASS DIRECT VISUALIZATION SYSTEMIn May of 2007, Boston Scientific introduced the SpyGlass Direct Visualization System. The goal of thesystem was to overcome the limitations of prior chole-dochoscopes and simplify peroral cholangioscopy.

Theoretically, at least, direct optical visualizationof biliary ducts has advantages. As discussed above,standard ERCP allows a radiographic view of theducts; however, interpretation and extrapolation arerequired. Radiologic imaging during ERCP may beinsufficient to make a correct diagnosis. As gastroen-terologists, we are trained to recognize, diagnose andtreat diseases with direct real time visualization ofpathology; SpyGlass now allows those trained in theprocedure to do just that. Further, the ability to biopsy

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Practical Points

• Easier to use than previous generation choledocho-scopes with added benefit of single user and improvedvisibility with irrigation channel

• First-generation device with expected refinements infuture generation technology

• Expands diagnostic and therapeutic applications whereERCP has fallen short, both peroral and percutaneous

• May avoid unnecessary surgery if indeterminate stric-tures on previous ERCP subsequently diagnosed asbenign with SpyGlass

• Variation in success among reported studies may be afunction of varying skill level of biliary endoscopist

• Utility for foreign body removal• Potential for extraluminal applications

Figure 1. SpyGlass mounted on duodenoscope. (Boston Scientific)

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within the biliary system, with direct view of a lesion,is now afforded with the SpyGlass System.

Major components of the system (Figure 1)include the SpyGlass® fiber optic probe, SpyScope®

access and delivery catheter and the SpyBite® biopsyforceps. A “single-use, single-operator” device, theSpyScope® catheter consists of four lumens; a) a 1.2mm accessory channel, through which the SpyBite®

forceps can pass, b) two irrigation channels and c) anoptic channel. This 10 Fr catheter allows four-quadrant

biliary viewing due to a tip that has four-way steeringcapabilities. The total length of the Access and Deliv-ery Catheter is 230 cm and is stabilized by the endo-scopist with its placement just below the operatingchannel of the duodenoscope. The SpyGlass fiberoptic probe, a “multiple-use” device, is a fragile 231cm long catheter with an outer diameter of 0.77 mmwhich easily passes through the SpyScope Catheter.As both a transmitter of light (6,000 pixels) and intra-ductal images, its angle of viewing is 70×. The SpyBite® forceps are “single-use,” similar to thecatheter, and have a central spike that minimizes the loss of small biopsies. Used in conjunction with thefiber optic probe, direct visualization of the biopsy siteis now possible.

The SpyGlass system is compatible with EHL andholmium laser, for stone fragmentation. EHL uses theprinciple of high pressure shock waves generated byhigh voltage discharge and laser treatment offersanother therapeutic alternative to EHL (4,5). Thisallows direct visualization of two proven methods ofablation for stones that may not be amenable toremoval by conventional therapies (i.e. stones toolarge to pass after sphincterotomy).

CLINICAL ASSESSMENT PRIOR TO SPYGLASS PROCEDUREWhile no standard patient protocol or evaluation hasbeen advocated prior to performing SpyGlass, generalguidelines are useful and are outlined here. The currenttrend has been toward performing ERCP and SpyGlassunder general anesthesia and therefore each patientshould have a routine laboratory evaluation. Thisincludes at minimum a complete blood count (CBC), achemistry panel (electrolytes, BUN, creatinine) and acoagulation panel (PT, PTT), no more than 14 dayspreceding the surgery. On arrival to the endoscopysuite or operating room (OR), the patient should havea full history and physical (H&P) performed, or atleast an “H&P update” if a full H&P has been per-formed within the past 30 days. Vital signs, whichshould be continuously monitored by anesthesia forthe duration of the procedure, should include a pulse-oximetry reading, blood pressure, pulse, respiratoryrate, as well as temperature.

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Table 1Diagnostic and Therapeutic applications of SpyGlassSingle-Operator Peroral Cholangiopancreatoscopy System

Diagnostic • Biopsy stricture under direct visualization (indetermi-

nate stricture, dominant stricture in primary sclerosingcholangitis)

• Evaluate fixed filling defect noted on prior radiologicstudy

• Differentiation of intraductal mass (benign vs. malignant)

• Precision mapping of intraductal tumor prior to resection

• Collection of significant fluid sample for cytology• Evaluate intraductal mucinous neoplasms under

direct vision• Evaluate choledochal cyst under direct vision• Evaluate post liver-transplant ductal ischemia under

direct vision• Evaluate intraductal spread of ampullary adenoma

under direct vision• Evaluate for infection (CMV, fungal infection) using

direct vision and tissue sampling

Therapeutic• Choledocholithiasis (EHL, laser lithotripsy, argon

plasma coagulation) • Photodynamic therapy• Nd-YAG laser ablation• Cystic duct stent placement• Foreign body removal• Extraluminal applications • Placement of stent through post liver transplant

tight stricture

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Confirmation of the indication(s) for performingthe procedure is also warranted. Routinely, transami-nases (AST, ALT), alkaline phosphatase (Alk P), biliru-bin and other markers of hepatic function (dysfunction)are obtained and reviewed prior to initiation of the pro-cedure. Imaging, usually via one or more separatemodalities, should also be reviewed as often they indi-cate when SpyGlass direct visualization is warranted. Aright upper-quadrant ultrasound is usually the firstmeans of biliary evaluation in patients who have aliver-function test (LFT) derangement. Focus should beon the common bile duct (CBD) size and course as wellas abnormalities noted within the visible biliary tree.The next form of radiographic evaluation may be com-puted tomography (CT); however, this not always theoptimal test for biliary tree visualization. A magneticresonance imaging (MRI) of the abdomen and pancreas(MRCP), if not included with the MRI abdomen, pro-vides a better evaluation of the biliary anatomy, tumorsand surrounding structures (6,7). MRI is not mandatorypre-procedure; in fact, in our experience, less than aquarter (22.2%) of our SpyGlass cases had an MRIprior, but all of our patient’s did have radiographicimaging of one form or another [CT, MRI/MRCP,ERCP, right upper quadrant ultrasound (US)]. It is alsolikely that many patients will have undergone ERCPpre-SpyGlass. In fact, the use of SpyGlass often hingeson the inability of ERCP to clinically distinguish thedifference between benign and malignant biliary stric-tures or lesions on fluoroscopy.

INDICATIONS AND CONTRAINDICATIONS FOR USE OF SPYGLASSA number of indications are standard for patientsundergoing ERCP. Commonly, this procedure is donefor evaluation and therapy of a number of conditionsincluding, but not limited to: obstructive jaundice, bil-iary strictures, choledocholithiasis, recurrent pancre-atitis (of unknown origin), suspected bile leaks andampullary neoplasms, intrahepatic biliary tract andpancreatic duct disease and trauma (both biliary andpancreatic), and unexplained and persistent LFTabnormalities (8).

SpyGlass is intended to provide direct visualiza-tion of the biliary tree for diagnostic and therapeutic

applications. Judah and Draganov have compiled anearly all-inclusive list of diagnostic uses for intraduc-tal endoscopy that range from the evaluation of fixed filling defects (on ERCP, cholangiogram orMRCP) to determining benign from malignant tumorsand subsequent mapping of intraductal tumors (prior tosurgery) to evaluating cysts and for ischemia (1). Ther-apeutic and sampling options are also highlighted;these include optically guided biopsies of indetermi-nate strictures and strictures seen in primary sclerosingcholangitis (PSC), fluid sampling for cytology and fur-ther tissue sampling for infection and cancer. Furtherabstracts and studies, as described below, have pushedthe limits of SpyGlass and what is now possible is ever-expanding. Table 1 reviews these numerousindications.

As for contraindications, if a patient is not med-ically suited to undergo an ERCP, they should not havethe SpyGlass procedure performed. Utilization ofanesthesia is recommended as the above proceduresmay last an hour or more. Patients with prior adversereactions to anesthesia, a prior history of underlying oractive heart disease, a propensity for arrhythmias anda history of lung disease will be considered at higherrisk for the procedure, and these risks may outweighthe benefits of endoscopic evaluation. As with everyprocedure performed within the OR or endoscopysuite, informed consent must be obtained prior to initi-ation. Potential procedure risks including abdominalpain, bleeding, perforation, infection, pancreatitis, car-diopulmonary arrest, and death should be listed on theconsent form and discussed with the patient beforedeciding whether or not to proceed.

SPYGLASS TECHNIQUE Boston Scientific supplies standard “manufacturer rec-ommendations” for the use of the SpyGlass system.The cholangioscopy procedure with the SpyGlass sys-tem is performed by a single operator with theSpyScope® access and delivery catheter positionedjust below the operating channel of the duodenoscope.This positioning allows the endoscopist to control boththe tip deflection wheels of the duodenoscope and theknobs of the SpyScope Catheter visualization systemwith the same hand. Stabilization of the both systems

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is performed with the physician’s other hand. The SpyGlass system is introduced into the therapeuticduodenoscope. The bile duct is cannulated (Figure 2),after a sphincterotomy as needed, and the SpyScope®

catheter guides the SpyGlass direct visualization probeinto the biliary tree. The SpyScope® catheter and Spy-Glass probe are maneuvered up to the desired area ofinterest within the duct for direct visualization.Selected ducts and branches of interest (Figure 3A)can be examined during repeated advancement andwithdrawal of the scope. If strictures (Figure 3B) orother biliary pathology is encountered, the SpyBite®

biopsy forceps guided by the SpyScope® catheter canbe introduced and an endoscopic guided biopsy taken(Figure 3C). Furthermore, as mentioned earlier, biliarytract stones can be seen under direct vision (Figure 3D)and EHL can be easily applied (Figures 3E, F).

Our experience has been similar to that describedby the manufacturer. Minimizing the use of contrastprevents clouding of the video with SpyGlass. Routineirrigation using the foot assisted washing system alsoimproved picture clarity. Generally four to six biopsiesare useful in increasing yield as is post biopsy aspira-tion of bile duct fluid for cytology.

POST SPYGLASS CARERoutine pre- and post- procedure care applies to allpatients having an ERCP and/or SpyGlass direct visu-alization. While SpyGlass itself lengthens the timerequired to perform a complete optically guided biliaryevaluation, data does not exist whether the procedurehas greater risk than ERCP alone. Despite efforts tominimize the risks of these procedures, mortality andmorbidity risks remain high with ERCP. More than 7%of patients undergoing ERCP have experienced a myr-iad of complications; this is up more than 1% fromprior decades (9,10). Ranging from mild to severe,everything from pancreatitis, infection, reaction toanesthesia, bleeding, perforation, cardiopulmonaryarrest, and death may occur. The risk of bleeding, forexample from sphincterotomy, is greater for the patienton an anticoagulant or with thrombocytopenia, and therisk of infection increases with biliary manipulation.Thus, the importance of post-SpyGlass care/monitor-ing must be stressed.

A majority of the risks inherent to performingERCP and SpyGlass occur within the first six hourspost-procedure. If performed on an outpatient basis,patients should be monitored in a post anesthesia careunit (PACU) or in a monitored room staffed by trainednurses. Even if the procedure is performed on an inpa-tient, the same level of awareness for adverse eventsshould be in place. Inpatients, as a general rule, arealso followed in the PACU for several hours prior toreturning to their room within the hospital. A lowthreshold for alerting the endoscopist about concernsof an adverse event should be in place. Even a smallchange in the patient’s status (e.g. rise in pulse, drop inblood pressure or an increase in abdominal pain) maybe the first indication of an adverse procedural eventand should be taken seriously. We routinely advocatethe use of antibiotics with SpyGlass in the form ofciprofloxacin or ampicillin/sulbactam.

CLINICAL TRIALS REPORTING ON SPYGLASS OUTCOMESChen, in a preclinical characterization of the SpyGlasssystem, used a bench simulator to directly compareSpyGlass to a control fiberoptic transendoscopic

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Figure 2. Anatomical Illustration depicting SpyGlass takingtargeted biopsy after cannulation of the common bile duct.(Boston Scientific)

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choledodochoscope with two-way deflection (10). Thebench simulator consisted of acetal guide blocks andsupports, glass tubing (mimicking the esophagus), andsilicone tubing (configured with a curvature as to simu-late in vivo bile ducts). The following capabilities of thetwo systems were assessed: accessing quadrants withinthe simulated bile duct with and without SpyBite forceps, opening and closing the forceps, accessingsimulated biopsy targets (monofilament suture knotswith a spherical diameter of 1.2 mm placed in eachquadrant approximately 18 cm proximal to the simu-lated papilla), and performing simulated biopsies, andease of insertion and removal of forceps through theworking channel. Main outcome measurements wererate ratios (RR) and 95% confidence intervals (CI).SpyGlass demonstrated higher success rates for

accessing all quadrants, both with (RR 2.00, 95% CI1.56–2.78) and without (RR 1.71, 95% CI 1.39–2.29)biopsy forceps. It also had higher success rates foraccessing biopsy targets (RR 2.09, 95% CI 1.60–2.91)and performing simulated biopsies (RR 2.94, 95% CI2.05–4.52). This study also looked at high level disin-fection (HLD) of the reusable optic probe andachieved microbial species log reductions of 6.0 to 7.0(criterion of effective HLD was a ≥6 log reduction).Lastly, this study looked at the feasibility of in vivobiopsy in a porcine model. The SpyGlass system wasadvanced into the biliary and hepatic ducts of fiveanesthetized pigs and biopsies were attempted at aboveand below the hepatic bifurcation. During pathologicexamination the adequacy of each specimen wasassessed on a gross (adequate, inadequate, no sample)

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Figure 3. (A) Visualization of multiple ducts. (B) Stricture visualized. (C) Biopsy forceps under direct visualization. (D) Directvisualization of large stone in duct. (E) Maneuvering of probe to contact stone just prior to EHL. (F) Stone pulverization duringEHL under direct visualization. (Boston Scientific)

A B C

D E F

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and histologic (excellent, adequate, inadequate, and nosample) basis. A total of 34 biopsies were taken (14above and 20 below the hepatic bifurcation). Ninety-one percent (31 of 34 bites) of the gross specimenswere deemed adequate. Ninety percent (28 of 31 spec-imens were rated adequate or excellent).

Chen and Pleskow, in a prospective observationalclinical feasibility study, evaluated the clinical utilityand safety of the SpyGlass system in 35 patients (11).Study inclusion criteria were failure of prior ERCP toeither answer a biliary diagnostic question or performa therapeutic intervention. Specific indication for SpyGlass included indeterminate stricture {22}, inde-terminate filling defect {5}, stone therapy {5}, cysticlesion {2} and gallbladder stent placement {1}. Themain outcome measurement was a procedural successrate defined as proportion of SpyGlass procedures inwhich the diagnostic or therapeutic objectives wereattained. This was achieved in 32 out of 35 patients(91%) [95% CI 77–98]. In the five patients with previ-ously failed stone therapy, SpyGlass-directed EHLsucceeded in five of five patients (100%). Nineteen oftwenty patients (95%) who underwent SpyGlassdirected biopsy had specimens deemed adequate forhistological examination. Sensitivity and specificity ofSpyGlass directed biopsy to diagnose malignancy was71% and 100%, respectively.

Several recent clinical trials/clinical studies havebeen reported in preliminary form in 2007 and 2008.Canlas, et al retrospectively evaluated the clinical util-ity, safety, and ease of use of SpyGlass during theirinstitution’s initial experience with the device (12). Insix patients, they assessed the following outcomes:success of introducing the device into the bile duct,successful identification of filling defects, use and suc-cess of electrohydraulic lithotripsy (if performed), anduse and success of directly visualized forceps. Five ofsix patients had successful cannulation of the commonbile duct. The one failed cannulation was secondary todifficult anatomy from a suspected malignant biliarystricture in the common bile duct. Identification of fill-ing defects occurred in four of the five cases wheresuccessful cannulation was achieved (three stones andone suspected malignancy). Biopsies were performedonce (in the case where suspected malignancyoccurred) and was successful in diagnosing a ductal

carcinoma. EHL via the SpyGlass device wasattempted in two patients (one with a CBD stone andone with a cystic duct stone) and partial stone clear-ance was achieved in each case. Failure of completelithotripsy was attributed to the size of the CBD stoneand inability to maintain adequate probe to stone con-tact in the cystic duct. The authors concluded that theSpyGlass system achieved adequate visualization ofthe biliary tree to facilitate both the diagnosis of biliarystrictures and lithotripsy of stones during ERCP.

Parsi, et al presented a case report of a 62-year-oldfemale patient status post- cholecystectomy withrecurrent pancreatitis, mildly elevated LFTS, and adilated biliary tree (13). Subsequent work-up withERCP times two, CT scan, and MRCP failed to pro-vide a diagnosis. SpyGlass revealed a foreign bodythat was found to be a remnant of a T-tube used duringthe patient’s cholecystectomy. The hollow (filled withcontrast during ERCP and bile during MRCP) andradiolucent (not seen on CT scan) nature of the T-tubeevaded detection with prior diagnostic modalities.Thus, direct cholangioscopy facilitated diagnosis andsubsequent removal of the foreign body.

Stevens, et al examined the performance of SpyGlass in treating biliary stones with EHL in 15patients who had previously failed biliary stone extrac-tion using conventional ERCP techniques (14). Stoneclearance was achieved in 85% of cases where EHLwas attempted. Sixty-one percent of cases cleared withone EHL treatment and 23% of cases cleared with twoEHL treatments. The mean number of EHL probesneeded to complete stone extraction was one (rangeone-to-two). There were no reported complications.

Kuperschmit, et al reviewed their initial experi-ence with SpyGlass and assessed its usefulness as botha diagnostic and therapeutic tool (15). In retrospectiveexamination of 26 cases, success in each of the fol-lowing areas was assessed: imaging the desired ductalstructures, performing EHL, and in guiding biopsy.The authors concluded that excellent visualization wasachieved in all cases. In spite of good stone visualiza-tion and EHL probe placement, stone clearance wasonly achieved in one out of four cases. They authorsconcluded that EHL was technically facilitated bySpyGlass but two cases of very hard stones provedrecalcitrant. Tissue was obtained in all patients and

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was diagnostic of malignancy in 4/13 patients. Theauthors concluded that SpyGlass added to their abilityto diagnose malignancy, though at a lower thanexpected yield. In the majority of cases, the authorsfound SpyGlass to be clinically useful.

Lo, et al reported on preliminary technical experi-ence with the device among three endoscopists in 22patients (16). SpyGlass indications included directbiopsy {6}, confirm ductal abnormalities {6}, examinestricture {5}, facilitate EHL {4}, and visualize fillingdefects {1}. A five-point scale was used to report theirobservations, with five being most favorable. Visual-ization upon bile duct entry was rated as poor (mean2.3). However, flushing with either saline or watereventually resulted in an acceptable examination (3.1).Satisfaction with quality of examination by locationwas as following: common hepatic duct/CBD > righthepatic duct > left hepatic duct/intrahepatic ducts.Global score for technical satisfaction was three.When compared to their prior experience with chole-dochoscopy, the three operators regarded SpyGlass aseasier to operate by one person {3.6}, having better tipdeflection {4}, easier to pass wire/optical probes (3.6),but inferior in brightness (2.4) and visualization of tar-get tissue (2.6). Overall SpyGlass was useful in 16cases (ruled out pathology in 10, directed biopsy infour, and facilitated EHL in two) and in six casesadded no value. The authors concluded that the SpyGlass device was relatively easy to use by a singleoperator, able to reach above the hepatic bifurcations,and had excellent performance with respect to tipdeflection, optical fiber protection, and tip-lockingmechanism. With regard to illumination and visualiza-tion, they concluded it was slightly suboptimal. Theyadmitted further experience was needed before defini-tive conclusions could be drawn.

Chen, et al reported their SpyGlass experiencewith direct access and visualization of the pancreaticducts [peroralpancreatoscopy (PP)] for pancreaticstone therapy and investigation of suspected pancre-atic lesions (17). Their aim was to document the per-formance, safety, and utility of the SpyGlass system in48 consecutive patients requiring PP for the followingindications: pancreatic stones {17}, indeterminatestrictures {11}, dilated ducts {5}, indeterminate fillingdefects {11} and mass {4}. EHL led to successful

stone clearance in eight out of 10 patients. Using dis-posable SpyBite forceps, PP-guided biopsies wereattempted in 10 patients and a mean 4.4 biopsy speci-mens per patient provided adequate specimens for his-tological analysis. No serious adverse events occurred.They concluded that for PP Spyglass is technically fea-sible, allows access to target sights in the main pancre-atic duct for visual inspection, stone therapy, and tissuesampling in most patients. They also concluded thatthe procedure could be safely performed in patientswith pancreatic stones, intraductal papillary mucinousneoplasm (IPMN), and indeterminate strictures. How-ever, they commented that its safety and clinical utilityhas yet to be proven in patients with small ducts and ornon-obstructed ducts. They also made the statementthat a smaller catheter diameter is preferred for pan-creatic application.

Raijman, et al assessed Spyglass performance, fea-sibility, and safety in 128 patients, 72 (56%) with ther-apeutic indications [CBD stones, pancreatic duct (PD)stones, and biliary strictures] and 56 (44%) with diag-nostic indications (abnormal LFT’s, abnormal imaging,and cholangiocarcinoma staging) (18). Peroralen-doscopy was utilized in 121 and percutaneous in seven.Spyglass was successful in all cases. Per-oral use waseasier than percutaneous, due to the ability of the duo-denoscope to control SpyGlass. Visualization wasdeemed good in 108, fair in 10, and poor in 10.Removal of the guide wire from its working channelimproved SpyGlass maneuverability. The use of EHLand biopsy forceps was possible in 65/70 patients. Infive patients the EHL probe could not be advanced dueto scope angulation. There was no associated morbid-ity. The authors concluded that the device is effective inthe evaluation and treatment of various biliary and pan-creatic tract diseases, modifying a pre-procedure diag-nosis in a significant number of patients. Per-oral usewas found to be easier compared to the percutaneousapproach. They felt further use and technical improve-ments were needed.

Navaneethan, et al evaluated the efficacy and prac-ticality of SpyGlass for diagnosis and therapy of bil-iary disorders as compared to conventional ERCP (19).After conventional ERCP was performed in 17patients, a total of 19 SpyGlass examinations were per-

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formed. Indications for the SpyGlass procedureincluded previously failed treatment for large biliarystones (N = 9) and indeterminate biliary stricture (N =10). Of note one patient had both stone and strictureand one patient underwent removal of a migrated intra-ductal metal coil (previously placed to embolize ahepatic artery aneurysm). Overall procedure successrate was 94.7% and cholangioscopic stone removalwith EHL was successful in 88.9%. SpyGlass alteredpatient management compared to the initial ERCP in42.1% of procedures. One procedural complication(aspiration) occurred with uneventful recovery. Theauthors concluded that SpyGlass provided a safemeans of expanding diagnostic and therapeutic appli-cations as compared to conventional ERCP.

Raijman and Fishman directly compared SpyGlassto an established choledochoscope (FCP-9P, Pentax,USA) in five patients (20). Indications included thefollowing: large choledocholithiasis {3}, bile ductstricture {1}, and biliary stricture {1}. The followingparameters were evaluated: ease in setting up, ease ofadvancement through the scope, time to complete thecholedochoscopic procedure, visual clarity, intraductalcannulation and maneuverability, irrigation, and abil-ity to provide therapy. Results showed that there wasno difference in ease of set up, ease of advancementthrough the scope, in ductal cannulation, or in time toperform and complete the procedure. EHL advance-ment was possible in all FCP-9P cases while it was notpossible in one SpyGlass case. When performed with-out a guide wire, intraductal maneuverability wasequal. Visual clarity was superior with FCP-9P.Intended outcome occurred in 100% of FCP-9P casesand 80% of SpyGlass cases. Authors concluded thatSpyGlass was effective in the evaluation and treatmentof various biliary tract diseases. They felt its majoradvantage compared to FCP-9P is that it is single oper-ator and has an independent irrigation channel. Theyopined that future refinement of the SpyGlass scope isneeded.

Chen, et al, in a 15 center 12 month follow-up reg-istry, documented performance and utility of peroralcholangioscopy (PO) using SpyGlass in 146 patientsrequiring PO for stone therapy or investigation of sus-pected pathology with and without biopsy (21). Proce-dural success was defined as the ability to visualize/

biopsy target lesion or initiate stone therapy. SpyGlassindications were non-PSC indeterminate strictures(39%), stone management (34%), exclude cancer inPSC (10%), other non-diagnostic ERCP findings (8%),indeterminate filling defect (6%), other (4%). Biopsieswere taken in 40% of patients. Overall procedural suc-cess was 89%. Preliminary sensitivity and specificityat 30 days relative to clinical diagnosis of malignancyare 90% and 89%, respectively. Fourteen seriousadverse events related to device/procedure occurred:cholangitis, bacteremia, abdominal pain, pancreatitis,liver abscess, abdominal distension, nausea, transienthypotension, and radiculopathy. The authors con-cluded that SpyGlass can be safely performed by a sin-gle operator, provides reliable access to target sites forvisual inspection, stone therapy, and tissue sampling,and obtains adequate histological samples. They alsoconcluded that the combination of visual diagnosis anddirected tissue sampling using SpyGlass may improvediagnostic accuracy in patients with indeterminate bileduct lesions.

Pleskow, et al looked at whether targeted biopsiesobtained under direct visualization might improvediagnostic sensitivity of intraductal biopsies, as ERCP-guided brushings and biopsies of indeterminate biliarystrictures have low sensitivity for the detection ofmalignancy (22) Sixty international multicenter reg-istry patients with indeterminate biliary strictures orfilling defects underwent ERCP followed by SpyGlasscholangioscopy with biopsy. The amount of tissueobtained at biopsy was deemed adequate in 87% ofcases. Sensitivity, specificity, positive predictive value(PPV), negative predictive value (NPV) of biopsies fordetection of malignancy in 29 patients who had at leastsix months of follow-up were 78%, 100%, 100%, and60%. The authors concluded targeted biopsies usingSpyGlass are feasible, safe, and well-tolerated. Theyalso concluded that SpyGlass had a high sensitivity fordiagnosing pancreatobiliary malignancies via biliarybiopsies obtained under direct visualization.

Loren, et al reported the clinical applications andtechnical performance of SpyGlass cholangioscopy/pancreatoscopy at three tertiary referral centers (23).Thirty-five patients underwent a total of 39 SpyGlassprocedures. Indications included: indeterminate biliarystricture (62%), choledocholithiasis (21%), pancreatic

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duct stones, evaluation of IPMN, suspected biliarymass, and cholangiocarcinoma surveillance. In 24% ofthe indeterminate biliary stricture cases, the clinicaldiagnosis was altered from suspected malignant stric-ture to benign stricture. Stone clearance with EHL orlaser was successful in 100% of the nine cases, requir-ing only one session in all but one case. Visualizationalone facilitated diagnosis in 7% of cholangioscopiccases and two-thirds of pancreatoscopic cases. Biopsywas performed in 24 cases and 88% yielded tissuedeemed adequate for histologic evaluation. Procedure-related complications occurred in five patients andwere all within the spectrum of those reported withother interventional pancreatobiliary procedures.

Raijman and Slivka evaluated the feasibility of theSpyGlass system for percutaneous use (24). Percuta-neous access to the pancreatobiliary system via percu-taneous transhepatic cholangiography (PTC) isindicated when ERCP has failed to access the biliarytree or when the papilla is inaccessible. Once percuta-neous access was achieved using standard interven-tional radiology techniques, the SpyGlass scopeloaded with the SpyGlass optical probe was introducedinto the bile duct using a standard 10 Fr sheath. In onepatient, introduction of the optical probe and a stan-dard 7 Fr sheath alone were sufficient. In all cases,direct visualization was achieved. Thus, diagnosticand therapeutic capabilities of PTC are expandedwhen used in conjunction with SpyGlass. With theexception of minimal oozing from EHL probe in onepatient, there were no complications.

Keswani, et al (25) described their preliminaryexperience in 26 patients who underwent SpyGlass ata single center. The most common SpyGlass procedureindications were evaluation of biliary {14} and pan-creatic {2}strictures. Other indications included evalu-ation of small filling defects, suspected malignancywithout stricture and placement of a bifurcation tumorstent. SpyBite directed biopsy was obtained in 13patients with a diagnosis of malignancy obtained infour patients. One of the nine patients with a negativeSpyBite biopsy was found to have cancer in follow-up.In two additional patients a malignant mass was biop-sied with conventional intraductal forceps after beingvisualized with SpyGlass. EHL was successfully per-formed in three cases, with one patient requiring fur-

ther lithotripsy. Mean procedure time was 80.5 min-utes, with a trend towards decreased procedure time asSpyGlass experience increased. Two patients devel-oped post-procedural interstitial pancreatitis. SpyGlassaltered clinical management in 14 patients (53.8%).The authors concluded that in the majority of patientsSpyGlass provides additional information. They feltthat it may be most useful in evaluating indeterminatestrictures and in performing EHL. Increased operatorexperience leads to decreased procedure time.

Aziz, et al evaluated the impact of SpyGlass onpatient care in cases where ERCP had previously iden-tified bile duct filling defects of uncertain origin (26).These defects included questioned stones {11}, sus-pected benign lesions {3}, suspected malignant lesions{4}, and indeterminate mass {2}. In ERCP cases ofquestioned stones SpyGlass confirmed stones in nineof 11 cases, directly visualizing a benign lesion in oneinstance and air bubbles in the other. In the threeERCP suspected benign lesions, SpyGlass demon-strated one benign lesion and two malignant lesions. Inthe four ERCP suspected malignant lesions, SpyGlassshowed two stones, one malignant lesion, and onebenign lesion. In the two ERCP suspected indetermi-nate masses, SpyGlass revealed stones in one and airbubbles in the other. Recommended follow-up basedon SpyGlass findings included SpyGlass directed EHLfor large stones (40%) and surgery (20%). The authorsconcluded that SpyGlass with and without biopsy ishighly accurate in identifying the etiology of bile ductfilling defects of uncertain etiology and had a favor-able impact on patient care. They also concluded thatSpyGlass was effective in identifying stones missedduring ERCP and in directing stone therapy in patientswho had failed conventional stone therapy.

Raijman, et al evaluated the performance, feasibil-ity, and safety of using SpyGlass and lithotripsy usingelectrohydraulic and holmium laser methods in themanagement of 41 patients with difficult bile ductstones (27). Six of the 41 patients underwent SpyGlassusing a percutaneous approach as they had previouslyundergone Roux-en-Y surgery with stones above anas-tomotic stricture. Indications for choledochoscopyincluded large choledocholithiasis {26}, intrahepaticlithiasis {10}, lithiasis associated with bile duct stric-tures {11} [seven with intrahepatic lesions], and

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Mirizzi syndrome {1}. Stone clearance was achievedin 37 patients after one procedure and in four patientsafter two procedures. There was no morbidity associ-ated with the use of SpyGlass. Authors concluded thatthe SpyGlass is effective in the evaluation and treat-ment of difficult extra-hepatic and intra-hepatic bileduct stones. In the majority of patients ductal clearancecan be achieved after one session. PO SpyGlass usewas technically easier compared to the percutaneousroute.

Wright, et al reported a case where SpyGlass facil-itated cholangioscopic placement of a guide wireacross a tight anastomotic stricture after an orthotropicliver transplantation (28). Previous attempts to cannu-late the stricture with a guide wire during ERCP hadfailed. ERCP management of tight strictures is a blindapproach and usually requires multiple attempts by theendoscopist in a hit or miss fashion. Following cannu-lation, the stricture was subsequently dilated andstented. The success of the SpyGlass procedure pre-vented the need for repeat ERCP, percutaneousapproach, or revision surgery.

TRANSLUMINAL SPYGLASS APPLICATIONSRecently, the first report of SpyGlass being used out-side the biliary tree or main pancreatic duct wasreported (29). A patient was referred for endoscopicultrasound (EUS) to further evaluate an 8-cm cysticlesion in the pancreas on CT considered suspicious butnot diagnostic for a pseudocyst. During EUS a suspi-cious pancreatic-cyst-wall abnormality was noted.Using a conventional needle-knife, a small cyst-gas-trostomy opening was created. The track was dilatedwith a 6-mm biliary balloon dilator. The SpyGlassaccess and a 10F delivery catheter and a 0.9-mm-diameter optical probe were introduced through the3.7-mm accessory channel of the echoendoscope andthen into the cyst. Under direct visualization, the wallof the cyst was carefully inspected the focal wallabnormality was biopsied with SpyBite biopsy for-ceps. The pathological findings were consistent withpseudocyst. The authors suggested several potentialEUS-assisted SpyGlass transluminal applications. Onepotential application is examining, taking biopsy, andguiding therapy of abdominal lymph nodes. Another is

EUS-guided SpyGlass mediastinoscopy. In more gen-eral terms they posit that it might have application innatural orifice transluminal endoscopic surgery(NOTES).

SUMMARYWhile much of the data is preliminary, SpyGlassappears to have overcome many of the limitations ofearlier choledochoscopes. Some of its major advan-tages include the fact that it is a single operator system,allows directed biopsy and, as standard for routineendoscopy, four-way steering capabilities. This systemallows direct visualization of previously noted lesionsas seen on endoscopic retrograde cholangiopan-cteatography or other radiologic means. Indicationsand contraindications for the procedure are straightfor-ward, and the therapeutic opportunities afforded withSpyGlass are growing. While admittedly only a firstgeneration device, a few disadvantages are apparent: attimes image clarity is slightly sub-optimal and thescope and components are fragile. In spite of some ofthese limitations it is currently a key component inevaluating biliary anatomy. Future prospective studieswill provide further insight into the therapeutic role ofendoscopy with SpyGlass. n

Financial and Competing Interest DisclosureDr. Roorda has no conflict to declare. Dr. Kupec has noconflict to declare. Dr. Sundaram serves on NIH andVA Study Section and advisory boards for Abbott Lab-oratories and UCB, Inc.

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