Holmium-yttrium aluminum garnet laser lithotripsy in the treatment of biliary calculi using single-operator cholangioscopy: a multicenter experience (with video) Sandeep N. Patel, DO,1 Laura Rosenkranz, MD,1 Bennett Hooks, MD,1 Paul R. Tarnasky, MD,2 Isaac Raijman, MD,3 Douglas S. Fishman, MD,4 Bryan G. Sauer, MD,5 Michel Kahaleh, MD5 San Antonio, Texas; Houston, Texas; New York, New York, USA

Endoscopic retrograde cholangiography has been the criterion standard treatment of bile duct stones since 1974.1,2 Use of standard endoscopic techniques such as sphincterotomy, extraction balloon, basket, or mechanical lithotripsy have been successful in approximately 90% of these patients.3-5 Electrohydraulic (EHL)6-8 and laser lithotripsy9-12 were introduced in the mid-1980s as new treatment modalities for the 10% to 15% of patients with refractory stones and were found to be very effective. Because of the increased risk of heat-induced perforation, these techniques have been performed under either direct cholangioscopic visualization7-10 or fluoroscopically with a Abbreviations: EHL, electrohydraulic; FREDDY, frequency-doubled double-pulse yttrium aluminum garnet; Ho:YAG, holmium-yttrium aluminum garnet; Nd:YAG, neodymium-yttrium aluminum garnet; SOC, single-operator cholangioscopy. DISCLOSURE: M. Kahaleh received research support for this study from the following companies: MaunKea Tech, Xlumena Inc, Aspire Bariatrics, and W.L. Gore & Associates. In addition, the following authors disclosed financial relationships relevant to this publication: S. N. Patel: Consultant for Boston Scientific and Pentax. P. R. Tarnasky: Speaker for Boston Scientific; consultant for Boston Scientific, Covidien, and Conmed. I. Raijman: Consultant for Boston Scientific, Covidien, Conmed, Takeda, and Novartis. M. Kahaleh: Consultant for Xlumena Inc and Boston Scientific. All other authors disclosed no financial relationships relevant to this publication.

stone/tissue detection system.13,14 Because both systems were essentially limited to only major medical centers, EHL and laser lithotripsy have been used sparingly. Single-operator steerable cholangioscopy (SOC) now permits the routine use of these technologies. Several lasers have been developed over the years for intraductal lithotripsy: pulsed-dye (coumarin green and rhodamine6G) and pulsed solid state (neodymium-yttrium aluminum garnet [Nd-YAG]), frequency-doubled double-pulse yttrium aluminum garnet [FREDDY], alexandrite, and holmium: yttrium aluminum garnet [Ho:YAG]). Of these, the holmium laser is the newest laser lithotrite to be introduced to stone fragmentation. The aim of our study was to determine the safety and efficacy of this new technology in patients with difficult bile duct stones refractory to conventional endoscopic methods.

METHODS Patients and endoscopic methods

Reprint requests: Bennett Hooks, MD, Diagnostic and Medical Clinic-IMC 1700 Springhill Ave, Mobile, AL 36604.

Between July 2007 and December of 2009, 69 patients (26 men and 43 women) presented to 1 of 4 participating study centers for laser lithotripsy of bile duct stone(s). The median age of the patients was 60 years (range, 20-96 years). All patients had undergone at least 1 (mean, 1.4; range, 1-6) failed endoscopic retrograde biliary clearance procedure(s) before their referral. Patients deemed refractory had 1 or more of the following clinical situations: (1) stone exceeding 2 cm in size or multiple stones greater than 1 cm, (2) limited sphincterotomy or sphincteroplasty because of anatomic constraints (small papilla, periampullary diverticulum), (3) stones proximal to a stricture or in difficult locations (cystic or intrahepatic ducts), and (4) impacted stones. Patients presenting with refractory bile duct stones underwent ERCP with SOC-guided Ho:YAG laser lithotripsy using a 365-mm SlimLine disposable laser probe (Lumenis, Santa Clara, CA). Before ERCP, written informed consent was obtained from all patients or from medical power of attorney/surrogates. The study protocol was approved by each institutional review board. Sedation was administered in all cases by either the gastroenterologist in the form of conscious sedation with continuous monitoring of vital signs per unit protocol or by the attending anesthesiologist via general anesthesia

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This video can be viewed directly from the GIE website or by using the QR code and your mobile device. Download a free QR code scanner by searching “QR Scanner” in your mobile device’s app store. Copyright ª 2014 by the American Society for Gastrointestinal Endoscopy 0016-5107/$36.00 http://dx.doi.org/10.1016/j.gie.2013.07.054 Received October 22, 2012. Accepted July 29, 2013. Current affiliations: Division of Gastroenterology and Nutrition, University of Texas Health Science Center, San Antonio, Texas, USA (1), Methodist Dallas Medical Center, Dallas, Texas, USA (2), Digestive Associates of Houston, St Luke’s Hospital, Houston, Texas, USA (3), Texas Children’s Hospital, Houston, Texas, USA (4), and Division of Gastroenterology and Hepatology, Department of Medicine, Weil Cornell Medical College, New York, New York, USA (5).

Patel et al

Holmium-YAG laser lithotripsy in the treatment of biliary calculi

or MAC. ERCP with SOC was performed in the standard fashion.15 All patients had a previously performed biliary sphincterotomy; however, extension of the existing sphincterotomy or balloon sphincteroplasty was performed occasionally to facilitate the procedure. Cholangiogram was performed to document the number of stones and size. SOC (SpyGlass, Boston Scientific, Marlborough, MA) was passed through the working channel of the duodenoscope and into the bile duct with or without a guidewire. Cholangioscopic visualization was assessed by the attending gastroenterologist on a quality scale of 1 to 4, 1 being poor visualization and 4 representing excellent visualization. Sufficient (R3) cholangioscopic visualization was achieved in all patients with aggressive intraductal water irrigation through the SOC at a rate of 80 mL/min. Once the stones were visually identified, the laser probe was passed through the wire port of the SOC and placed in very close proximity to the stone. Laser power settings between 8 and 12 W were chosen to initiate lithotripsy. Short bursts were applied by stepping on the foot pedal attached to the laser generator for 5 seconds. This was repeated until adequate fragmentation was achieved. The total energy used per session for each patient was recorded. Stone fragments were then removed with standard extraction balloons and/or baskets. Ductal clearance was determined by occlusion cholangiogram or cholangioscopically. All patients received an intraprocedural dose of intravenous antibiotic because of the possible risk of transient bacteremia and cholangitis. Repeat ERCP sessions were performed as necessary to achieve complete stone clearance. Safety and efficacy parameters were retrospectively collected using a standardized data collection form.

Laser lithotripsy The laser used in this study was the Lumenis VersaPulse Ho:YAG transmitted via a GI SlimLine 365-mm silica fiber. Ho:YAG is a pulsed solid state laser with a wavelength of 2140 nm, which is very near the wavelength of water (1940 nm), and a pulse length of 500 ms. Power output was created using a 100-W generator by adjusting the energy (joules) and frequency (Hertz). In reference to our ex vivo animal studies, 8 to 12 W was used in bursts of no more than 5 seconds.16 Bursts of laser were repeatedly delivered until adequate fragmentation was achieved or up to a total energy of 1 kW.

TABLE 1. Laser lithrotripsy patients Total number of patients

69

Extrahepatic stones

57 (82%)

Intrahepatic stones

8 (12%)

Cystic duct stones

4 (6%)

Prior failed ERCPs, mean (range)

1.4 (1-6)

Sessions needed for stone clearance, mean (range)

1.2 (1-3)

Patients requiring 1 session

51 (74%)

Complete clearance of bile duct

67 (97%)

Procedural time, min, mean Procedure-related adverse events

69 3 (4%)

RESULTS Complete removal of bile duct stones was achieved in 67 of 69 patients (97%). In 51 of 69 patients (74%), biliary clearance was accomplished in 1 endoscopic session. Stones were located in the extrahepatic biliary system in 57 of 69 patients (82%), the intrahepatic biliary system in 8 of 69 patients (12%), and the cystic duct in 4 of 69 patients (6%). The 4 patients with cystic duct stones presented with biliary obstruction (Mirizzi’s syndrome). The average stone size in patients with a single stone was 20.2 mm (range, 10-36 mm). Forty-seven of 69 (68%) patients had stones greater than 2 cm. Successful extraction of stones in this group of patients occurred in 46 of 47 patients (98%) and was similar to that of the other patients (21/22, 95%). To facilitate removal of fragmented stones, endoscopic papillary balloon dilation (12-18 mm) and mechanical lithotripsy were performed in conjunction with laser lithotripsy in 7% and 17%, respectively. Laser lithotripsy failed in 2 patients who ultimately required biliary surgery. One patient had multiple large cystic duct stones, and the other failure occurred in a patient in which the stone (21 mm) was embedded in the common bile duct (12 mm). The overall adverse event rate was 4.1%, with 2 patients experiencing minor bleeding of bile duct wall and 1 patient with mild post-ERCP pancreatitis. All patients recovered fully with conservative management (Table 1).

Power ðwattsÞ Z EnergyðjoulesÞ  Frequency ðHertzÞ Total energy ðkWÞ Z EnergyðkJÞ  Frequency ðkHzÞ  TimeðsecondsÞ

DISCUSSION

Cholangioscopic-guided laser lithotripsy was performed with the SOC (SpyGlass, Boston Scientific).

To our knowledge, this is the largest clinical study evaluating the technical success and safety of Ho:YAG laser lithotripsy for the management of difficult bile duct stones. The theory of laser (light amplification through stimulated emission of light) dates back to the turn of the 20th century. The first operating laser was

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Cholangioscopy

Holmium-YAG laser lithotripsy in the treatment of biliary calculi

Patel et al

Figure 1. Examples of the absorptive length of different lasers, this correlates with tissue penetration. Note the length of Neodynium (Nd) as opposed to Homium (Ho).

Figure 2. This shows both the photo-mechanical effect of the Ho:YAG laser and the safety of the Ho:YAG laser. The cavitation bubble is needed for stone fragmentation, but cutting of tissue should not occur unless you are within a millimeter of the bile duct wall.

developed in 1960 and found its first application in medicine shortly thereafter. Since then, laser has rapidly gained an important role in many medical and surgical applications because of its unique versatility of achieving fragmentation, coagulation, ablation, and incision. In the field of gastroenterology, lasers have been used to ablate early and advanced GI cancer, coagulate bleeding ulcers and angiodysplasias, and fragment biliary stones. The first endoscopic retrograde application of laser lithotripsy for the treatment of bile ducts stones occurred in Germany in 1986 using pulsed Nd-YAG.17 Since then,

several laser systems have been developed, including coumarin and rhodamine-6G pulsed dyes as well as pulsed solid state varieties like quality-switched Nd-YAG, FREDDY, CO2, and, most recently, Ho:YAG. The physical properties of the lasers are determined by several factors, namely wavelength, pulse width, and energy. These factors influence the particular laser beams effect on tissue and stones (Fig 1.). Some lasers, such as CO2 (wavelength, 10,600 nm), demonstrate shallow depth of penetration (0.1 mm) and are effective at ablation or incision. Lasers with shorter wavelengths, such as Nd:YAG (wavelength, 1064 nm),

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Holmium-YAG laser lithotripsy in the treatment of biliary calculi

Figure 3. This schematic shows how the distance of the laser fiber tip from the stone has to be managed for maximum fragmentation. The optimal distance for the Ho:YAG laser is 1-2mm. If you go beyond 2mm the fragmentation is lost and if less than 1mm there is a drilling effect in the center of the stone as opposed to the optimal fragmentation effect.

penetrate tissue more deeply (O5 mm) and provide significant coagulation and thermal effects plus or minus injury. The Ho:YAG laser has a wavelength of 2140 nm, which is very near the wavelength of water (1940 nm). This property of holmium is responsible for many of its favorable attributes. The tissue penetration of Ho:YAG is 0.5 mm as opposed to 5 mm with Nd:YAG. Holmium demonstrates both the ablative effects of CO2 upon direct contact with the target and coagulation effects of Nd:YAG when at a slight distance from the target. Holmium is absorbed 60 times more readily in water than Nd:YAG, making it extremely safe for stone fragmentation in an aqueous media. Laser lithotripsy occurs as a result of a sequence of events. The pulsed Ho:YAG laser delivers short 500-ms pulsations of optical energy to the tip of the fiber, which in an aqueous solution causes instantaneous fluid evaporation and creates a cavitation bubble known as the “Moses effect.” This cavitary bubble oscillates and then implodes violently, leading to the generation of a shockwave at the fiber tip that is then transmitted to the stone. For maximum fragmentation to occur, a distance of 1 to 2 mm is required between the fiber tip and stone. As this distance decreases or the probe is in contact with the stone, the cutting/drilling effect of the laser becomes more prominent (Figs. 2 and 3). EHL uses a high-energy electric spark in conductive saline solution media to create a cavitary bubble for fragmentation. Although very effective, the theoretical disadvantage of nonfocused high-energy fragmentation is enhanced

potential for bile duct trauma. Studies evaluating EHL have shown it to be an effective lithotripter with success rates of 79% to 98% (m Z 89%); however, EHL has an associated morbidity of 3% to 15% (m Z 10%).18 Similarly, short-wavelength laser lithotriptors (coumarin,9 rhodamine-6G,14 Nd:YAG,17 and FREDDY19) have been shown to be effective at stone fragmentation in 80% to 95%, with morbidity as high as 23% reported in some series. In the case of EHL and short-wavelength lasers, adverse events such as hemobilia and ductal perforation have been shown to be related to high-energy shockwaves and thermal injury. Previous studies have shown that holmium creates a much lower energy shockwave in comparison with EHL and the other lasers.20,21 Our study shows that the low energy shockwave created by Ho:YAG is effective in the fragmentation of complex stones but associated with a low morbidity. The main limitation related to the widespread use of this technique is the skill set required to achieve safe biliary clearance and the initial cost of set-up, which approaches over $100,000 for a 100-W generator. Portable 20-W generators have recently become available to the marketplace at a significantly lower cost. In conclusion, SOC-guided Ho:YAG lithotripsy is a safe and effective treatment for patients with difficult to manage biliary stones. Comparative studies with EHL for fragmentation of stones as well as other studies evaluating holmium’s other properties of ablation, incision, and coagulation are currently ongoing.

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Salvage ESD for recurrence of esophageal SCC after definitive CRT

REFERENCES 1. Kawai K, Akasaka Y, Murakami I, et al. Endoscopic sphincterotomy of the ampulla of Vater. Gastrointest Endosc 1974;20:148-51. 2. Classen M, Demling L. Endoskopische sphincterotomie der papilla vateri und steinextraktion aus dem ductus choledochus [In German]. Dtsch Med Wochenschr 1974;99:469-76. 3. Geenen JE, Vennes JA, Silvis SE. Resume of a seminar on endoscopic retrograde sphincterotomy (ERS). Gastrointest Endosc 1981;27:31-8. 4. Soehendra N, Grimm H, Berger B, et al. Endoskopische behandlungsmogglichkeiten [In German]. 1988;1:2-9. 5. Cotton PB. Nonoperative removal of bile duct stones by duodenoscopic sphincterotomy. Br J Surg 1980;67:1. 6. Sievert CE, Silvis SE. Evaluation of electrohydraulic lithotripsy on human gallstones. Am J Gastroenterol 1985;80:854. 7. Leung JWC, Chung SSC. Electrohydraulic lithotripsy with peroral choledochoscopy. Br J Med 1989;299:595-8. 8. Siegel JH, Ben Zvi JS, Pullano WE. Electrohydraulic lithotripsy. Gastrointest Endosc 1990;36:134-6. 9. Kozarek RA, Low DE, Ball TJ. Tunable dye laser lithtripsy: in vitro studies and in vivo treatment of choledocholithiasis. Gastrointest Endosc 1988;34:418-21. 10. Ell C, Lux G, Hochberger J, et al. Laserlithotripsy of common bile duct stones. Gut 1988;29:746-51. 11. Cotton PB, Kozarek RA, Shapiro RH, et al. Endoscopic laser lithotripsy of large bile duct stones. Gastroenterology 1990;99:1128-33. 12. Ponchon T, Gagnon P, Valette PJ, et al. Pulsed dye laser lithotripsy of bile duct stones. Gastroenterology 1991;100:1730-6.

Koizumi et al 13. Neuhaus H, Hoffman W, Gottlieb K, et al. Endoscopic lithotripsy of bile duct stones using a new laser with automatic stone recognition. Gastrointest Endosc 1994;40:708-15. 14. Ell C, Hochberger J, May A, et al. Laser lithotripsy of difficult bile duct stones by means of a rhodamine-6G laser and an integrated automatic stone-tissue detection system. Gastrointest Endosc 1993;39:755-62. 15. 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;65:832-41. 16. Patel SN, Kiker D, et al. Holmium:YAG laser safety data on bile duct epithelium in the porcine model. Gastrointest Endosc 2009;69:AB142. 17. Ell C, Hochberger J, Muller D, et al. Laser lithotripsy of gallstones by means of a pulsed neodymium YAG laser: in vitro and animal experiments. Endoscopy 1986;18:92-4. 18. Rosenkranz L, Patel SN. Endoscopic retrograde cholangiopancreatography for stone burden in the bile and pancreatic ducts. Clin North Am 2012;22:435-50. 19. Cho Y, Cheon Y, Moon J, et al. Clinical role of frequency-doubled double-pulsed yttrium aluminum garnet laser technology for removing difficult bile duct stones. Gasstrointest Endosc 2009;70:684-9. 20. Weickert U, Muhlen E, Janssen J, et al. The holmium-YAG laser: a suitable instrument for stone fragmentation in choledocholithiasis. The assessment of the results of its use under babyscopic control. Dtsch Med Wochenschr 1999;124:514-8. 21. Das AK, Chiura A, Conlin MJ, et al. Treatment of biliary calculi using holmium: yttrium aluminum garnet laser. Gastrointest Endosc 1998;48: 207-9.

Salvage endoscopic submucosal dissection for the esophagus-localized recurrence of esophageal squamous cell cancer after definitive chemoradiotherapy Shigeto Koizumi, MD, PhD,* Mario Jin, MD, PhD,* Tamotsu Matsuhashi, MD, PhD,* Shin Tawaraya, MD, Noboru Watanabe, MD, Masayuki Sawaguchi, MD, Noriyoshi Kanazawa, MD, Yumi Yamada, MD, Kengo Onochi, MD, Yuko Kimura, MD, Reina Ohba, MD, PhD, Jinko Kataoka, MD, PhD, Natsumi Hatakeyma, MD, PhD, Hirosato Mashima, MD, PhD, Hirohide Ohnishi, MD, PhD Akita, Japan

Reprint requests: Mario Jin, MD, PhD, Department of Gastroenterology, Akita University Graduate School of Medicine, 1-1-1 Hondo, Akita City, Akita 010-8543, Japan.

The incidence of esophageal cancer is increasing worldwide, and its prognosis is still poor.1 Although surgery is the best treatment, two thirds of cases of esophageal cancer are inoperable at the time of diagnosis because of advanced clinical stages and/or patient comorbidities.1 Thus, chemoradiotherapy (CRT) has been applied as a definitive treatment for inoperable locally advanced esophageal squamous cell carcinoma (SCC)2-4 because it can induce the complete remission. The use of definitive CRT (dCRT) has been increasing the 5-year survival rate of SCC by 13% to 27%.2-4 However, the relatively high incidence of local recurrence after dCRT is a major problem that needs to be resolved.2 Salvage surgery is generally considered for the treatment of a recurrence of esophageal cancer after dCRT. However, its morbidity and surgical risk are high,5 with

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Abbreviations: CRT, chemoradiotherapy; dCRT, definitive chemoradiotherapy; ESD, endoscopic submucosal dissection; SCC, squamous cell carcinoma. DISCLOSURE: The authors disclosed no financial relationships relevant to this publication. *Drs Koizumi, Jin, and Matsuhashi contributed equally to this article. Copyright ª 2014 by the American Society for Gastrointestinal Endoscopy 0016-5107/$36.00 http://dx.doi.org/10.1016/j.gie.2013.09.012 Received July 13, 2013. Accepted September 11, 2013. Current affiliations: Department of Gastroenterology, Akita University Graduate School of Medicine, Akita, Japan.

Holmium-yttrium aluminum garnet laser lithotripsy in the treatment of biliary calculi using single-operator cholangioscopy: a multicenter experience (with video).

Holmium-yttrium aluminum garnet laser lithotripsy in the treatment of biliary calculi using single-operator cholangioscopy: a multicenter experience (with video). - PDF Download Free
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