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Endoscopic treatment of retained bile-duct stones by using a balloon catheter for electrohydraulic lithotripsy without cholangioscopy
Endoscopic treatment of retained bile-duct stones by using a balloon catheter for electrohydraulic lithotripsy without cholangioscopy Jong Ho Moon, MD, Sang Woo Cha, MD, Chang Beom Ryu, MD, Young Seok Kim, MD, Su Jin Hong, MD, Young Koog Cheon, MD, Young Deok Cho, MD, Yun Soo Kim, MD, Joon Seong Lee, MD, Moon Sung Lee, MD, Chan Sup Shim, MD, Boo Sung Kim, MD Seoul, Korea
Background: Electrohydraulic lithotripsy is a highly effective method for fragmenting biliary stones, but direct visual control is required. The efficacy and the safety of electrohydraulic lithotripsy without cholangioscopy by using a balloon catheter were evaluated in patients with bileduct stones that could not be extracted by using standard techniques. Methods: Nineteen patients with extrahepatic bile-duct stones that could not be extracted by using conventional endoscopic methods, e.g., mechanical lithotripsy, were selected to undergo electrohydraulic lithotripsy without peroral cholangioscopy. An electrohydraulic lithotripsy probe with a 3.0F radio-opaque tip was inserted through a balloon catheter. Electrohydraulic lithotripsy was performed under fluoroscopy until the fragmented stone could be captured in a large basket for mechanical lithotripsy. Endoscopic removal of the fragments was attempted during the electrohydraulic lithotripsy session. Results: Stones were successfully fragmented in 17 of 19 patients. In 16 patients (84.2%), the bile duct was cleared of all stones. A mean of 1.8 endoscopic sessions was required for complete removal. Additional mechanical lithotripsy was performed in 9 (56.2%) of the 16 patients. Minor complications were noted in 4 patients (2 hemobilia, 1 pancreatitis, 1 cholangitis). There was no 30-day mortality. Conclusions: For a selected group of patients with bile-duct stones not extractable by using standard techniques, fluoroscopically controlled electrohydraulic lithotripsy with a balloon catheter seems to be an effective method of fragmentation. (Gastrointest Endosc 2004;60:562-6.)
Currently, about 90% of patients with extrahepatic bile-duct stones are treated non-surgically by endoscopic sphincterotomy (ES) and stone extraction with a Dormia basket or by balloon catheter. With the addition of mechanical lithotripsy, the success rate for endoscopic stone extraction may reach 95%.1-4 However, these conventional endoscopic methods may fail when stones are firmly impacted, extremely large, and/or inaccessible because of anatomic problems, e.g., bile-duct stenosis. In such cases, additional methods are required, such as extracorporeal shock wave, intracorporeal Received December 19, 2003. For revision May 10, 2004. Accepted June 29, 2004. Current affiliations: Digestive Disease Center, Institute for Digestive Research, Soon Chun Hyang University College of Medicine, Seoul, Korea. This study was presented in part as an abstract at the annual meeting of the American Society for Gastrointestinal Endoscopy, May 20, 2003, Orlando, Florida (Gastrointest Endosc 2003;57:AB188). Reprint requests: Chan Sup Shim, MD, PhD, Digestive Disease Center, Soon Chun Hyang University Hospital, 657 HannamDong, Yongsan-Ku, Seoul 140-743, Korea. Copyright Ó 2004 by the American Society for Gastrointestinal Endoscopy 0016-5107/$30.00 PII: S0016-5107(04)02012-7 562
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electrohydraulic, or laser lithotripsy.5 Intracorporeal lithotripsy has the advantage that it can be applied during the initial endoscopic session. Electrohydraulic lithotripsy (EHL) uses high-pulse energy to disintegrate stones and has the advantage of being inexpensive; however, continuous visual control of the fragmentation process, via a ‘‘motherbaby’’ endoscope system, may be required for safety, because of the potential for accidental damage to the bile-duct wall.6,7 Because it requires two skilled endoscopists, cholangioscopy is available in only a few referral centers. Moreover, a peroral cholangioscope is expensive, fragile, and difficult to use.8-11 A balloon catheter was used for EHL in an effort to improve fluoroscopic targeting and to prevent damage to the bile-duct wall. Experience with this device system and method in patients with bile-duct stones that could not be extracted by using conventional methods is described. PATIENTS AND METHODS Patients Nineteen patients (11 women, 8 men; mean age 67 years, range 37-84 years) with extrahepatic bile-duct stones were included. Before EHL, at least one attempt at endoscopic extraction of the stones that included ES and mechanical VOLUME 60, NO. 4, 2004
Retained bile-duct stones treated by balloon catheter for lithotripsy
J Moon, S Cha, C Ryu, et al.
lithotripsy was made in all the patients. Stone removal by using conventional methods failed because of the inability to capture the stones in the basket for mechanical lithotripsy. The main reasons were the following: large stone size (6 patients) and stone impaction (13 patients). Four patients had biliary strictures. Nine (47.4%) had undergone cholecystectomy. Cholecystolithiasis was present in 5 patients (26.3%). In 78% of the patients, jaundice was the principal symptom that led to the diagnosis of stones. Nearly two thirds of the patients (62%) had pain in the upper abdomen, and, in third (33%), there were initial signs of cholangitis. Maximum stone diameter was measured on the retrograde cholangiogram before EHL (by using the diameter of the distal end of a standard duodenoscope as a reference to compensate for magnification). With respect to the largest stone in all patients, the mean diameter was 23 mm (range 16-42 mm); the mean number of stones was 2.6 (range 1-5). Exclusion criteria were coagulopathy and refusal to undergo EHL. When endoscopic stone extraction was unsuccessful, a nasobiliary catheter was inserted for biliary drainage and subsequent cholangiography. In two patients, percutaneous transhepatic biliary drainage (PTBD) was established at another institution. The study was approved by our institutional review board. Written informed consent was obtained from each patient for EHL. Methods Lithotripsy procedure. An electrohydraulic shock wave generator (Lithotron EL-27; Olympus Optical Co., Hamburg, Germany), set at an output of 2000 V, was used to generate shock waves of increasing frequency (intensity up to 500 mJ), which were applied as a continuous sequence of discharges. A balloon catheter was used to center the EHL probe on the stone and to avoid contact with the bileduct wall (Fig. 1). The lumen of a standard extraction balloon catheter (Wilson-Cook Medical Inc., WinstonSalem, N.C.), with an 18-mm-diameter balloon, was expanded to accommodate the 3.0F EHL probe. The catheter was 6.8F in diameter and 2 m in length. The 3m-long EHL probe, with a 3.0F radio-opaque tip (Olympus), was passed through the lumen of the modified balloon catheter. Extreme caution was exercised to avoid kinking of the probe. Then, the balloon catheter was inserted through the 3.2-mm-diameter accessory channel of a standard duodenoscope (JF-240; Olympus Optical Co., Ltd. Tokyo, Japan). The balloon catheter with EHL probe then was introduced into the bile duct. The tip of the balloon catheter was positioned near the stone, and the balloon was expanded. The tip of EHL probe was advanced a few millimeters beyond the radio-opaque tip of the balloon catheter under fluoroscopic guidance to ensure that the EHL probe was positioned on the stone surface. Fluoroscopy was used to target the stone and to monitor fragmentation. Lithotripsy was continued until the stones were sufficiently fragmented to allow capture in a large basket for mechanical lithotripsy (StoneBuster; GIP Medizintechnik GmbH, Achenmu¨hle, Germany). During EHL, the bile duct was continuously irrigated with VOLUME 60, NO. 4, 2004
Figure 1. Bile-duct stone and balloon catheter with electrohydraulic lithotripsy probe.
a mixture of contrast medium and saline solution. A fluid medium is required for generation of electrohydraulic shock waves. Irrigation also allowed visualization of stone fragments and clearing of debris from the duct. Bile was aspirated intermittently via the drainage tube and was inspected. Hemobilia was defined as any visible blood in the aspirate or duodenoscopic observation of blood flowing from the papillary orifice. Removal of stone fragments. After stone disintegration, endoscopic extraction of stones and fragments was attempted with a Dormia basket and balloon catheter during the EHL session. Mechanical lithotripsy was used if a stone fragment was still too large for basket or ballooncatheter extraction. The maximum duration time permitted for endoscopic stone removal was 45 minutes. If, at that time, ductal clearance was incomplete, a nasobiliary catheter was inserted, and antibiotics were administered. A further attempt to remove the stone fragments was made 3 days later. Failure of EHL was defined as the inability to achieve complete bile-duct clearance after a maximum of 3 lithotripsy sessions. Follow-up All the patients were followed for at least 2 days after the EHL. Follow-up included simple radiographs and laboratory tests (Hb, white blood cell count, bilirubin, alanine aminotransferase, aspartate aminotransferase, creatinine, GASTROINTESTINAL ENDOSCOPY
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Retained bile-duct stones treated by balloon catheter for lithotripsy
Figure 2. A, Cholangiogram showing stone impacted in bile duct with metal tip of EHL probe (arrow) in contact with stone; balloon (arrowhead) at end of balloon catheter has been expanded to position probe properly. B, Cholangiogram made during EHL, showing multiple stone fragments. C, Cholangiogram showing complete clearance of stones from bile duct.
serum urea nitrogen, amylase, lipase). The occurrence of a complication within 30 days of the final EHL was assessed by telephone interview or a patient visit.
RESULTS Lithotripsy Stone fragmentation by EHL without direct visual control was successful in 17 of 19 patients (89.5%) (Fig. 2). Stones could not be fragmented in two patients in whom positioning of the tip of the EHL probe on the stone was inadequate. One patient was later treated successfully by extracorporeal shock wave lithotripsy (ESWL). The other patient was treated palliatively by placement of a biliary endoprosthesis. Bile-duct clearance Complete duct clearance of stones was achieved in 16 of 19 patients (84.2%). Even though the stones were fragmented, complete removal was unsuccessful in one patient with a biliary stricture who was subsequently treated by the percutaneous transhepatic cholangioscopic approach. Of the 16 patients in whom ductal clearance was achieved, 6 (37.5%) underwent one endoscopic session, 8 (50%) required two sessions, and two (12.5%) had 3 sessions. The mean number of sessions needed for complete stone removal was 1.8 6 0.7. After EHL, 9 patients (56.2%) underwent mechanical lithotripsy to achieve sufficient fragmentation for complete stone clearance. 564
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Complications During EHL, transient hemobilia was observed in two patients. However, the bleeding stopped spontaneously after EHL, and transfusion was not required. Mild pancreatitis and cholangitis occurred in one patient each. All of these patients were treated conservatively after lithotripsy for 3 days in the hospital without further complication. DISCUSSION Standard endoscopic methods for removal of stones from the bile duct are unsuccessful in up to 5% to 10% of patients, because the stones are too large or are impacted.12 Even with mechanical lithotripsy, the failure rate is high in patients with stones 20 mm or more in diameter.4 Treatment of these patients requires the use of complementary techniques to achieve complete stone extraction. Stones difficult to extract can be removed by using a variety of methods. The effectiveness of intracorporeal and extracorporeal lithotripsy has been demonstrated in various studies. Extracorporeal and intracorporeal lithotripsy have comparable success rates of 70% to 98% in patients with bileduct stones resistant to extraction.13 ESWL, which has a high rate of successful fragmentation, extends non-surgical therapy for bile-duct stones to include extremely large stones.14-16 However, the stone fragments produced by ESWL frequently are too large for spontaneous passage, and, thus, further VOLUME 60, NO. 4, 2004
Retained bile-duct stones treated by balloon catheter for lithotripsy
endoscopic procedures are required to achieve complete ductal clearance.14,16 Because of the high cost of a lithotripter, ESWL is performed in relatively few centers. Success rates of 82% to 90% after a mean of 1.3 to 2.1 sessions are reported for intracorporeal laser lithotripsy (ILL).11,17 The efficiency and the safety of laser lithotripsy appear to be comparable with EHL performed under cholangioscopic guidance.7 ILL with a tissue-stone recognition system is potentially safer than EHL, which may result in hemobilia or bile-duct damage.8 However, it is difficult and time consuming to target stones by fluoroscopy for ILL, because the positions of the small-diameter tip and radiolucent laser fiber inserted through the catheter are invisible.18 Another major disadvantage of the laser system is high cost. Silvis et al.19 reported the first transpapillary EHL in abstract form in 1986. EHL has been shown to be effective for endoscopic removal of bile-duct stones that are difficult to extract by using readily available techniques.8,20-22 However, bile-duct perforation, because of direct contact between the probe and duct wall, has been reported after EHL.8,20,23 Thus, direct visual control is required for EHL, because the shock waves may damage the bile duct. Cholangioscopy plus saline solution irrigation is routinely performed during EHL.8 Continuous irrigation usually is achieved via a nasobiliary catheter introduced into the bile duct before EHL. However, cholangioscopy with a ‘‘mother-baby’’ endoscope system requires two experienced endoscopists and is available in only a few centers. Moreover, the peroral cholangioscope is fragile, and the initial cost of the instruments is high.24 Also, cholangioscopic guidance during EHL often is difficult when clouds of stone debris obscure the view despite irrigation via a nasobiliary catheter. The EHL probe currently available is more flexible and thinner than earlier versions and can be inserted through a modified balloon catheter 7F in diameter, which can be used in combination with a standard duodenoscope. The radio-opaque tip of an EHL probe is advanced from the balloon catheter and onto the stone under fluoroscopy. Siegel et al.25 described the technical aspects of EHL by using a similar system, although clinical details were not given, nor were details concerning the EHL probe and balloon catheter. They injected a mixture of contrast and saline solution before performing EHL. However, continuous bile-duct irrigation via a biliary catheter is needed to provide a fluid medium for effective generation and conduction of electrohydraulic shock waves, as well as clearing stone debris to maintain fluoroscopic visualization.26 Complete EHL fragmenVOLUME 60, NO. 4, 2004
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tation of a large stone seems to require a long period of time. During a prolonged application of EHL, contact with the bile-duct wall may occur, even when the balloon catheter is used to fix the position of the probe. Therefore, shorter application times are more satisfactory. The mean diameter of the largest stones in the present series was 23 mm. To decrease the application time, mechanical lithotripsy was used after initial stone fragmentation by EHL (56.2% of cases). Siegel et al.25 attempted complete fragmentation and subsequent clearance of the bile duct by EHL alone. EHL with a balloon catheter is recommended by us for use until the fragment size is such that mechanical lithotripsy can be used. In this way, the chance of a serious EHL-related complication can be decreased. A certain level of endoscopic skill is required to bring the balloon catheter with EHL probe into close proximity with the surface of a stone. If a stone is eccentric in position (e.g., Mirizzi syndrome), it is difficult to direct the probe, and the risk of perforation is substantially increased. Positioning of the balloon may be unsatisfactory in certain anatomic conditions, e.g., intrahepatic bile-duct stones or stones located proximally in a markedly tortuous, angulated bile duct. There is a concern during EHL for the possibility of serious complications, such as duct perforation or severe bleeding. There were only two minor episodes of bleeding in the present series, but the number of patients treated was relatively small. If EHL is widely adopted, more serious complications may be encountered. Therefore, EHL should be performed with caution by experienced biliary endoscopists. In addition, EHL is associated with a high level of exposure to ionizing radiation for the patient and the endoscopist. However, improvements in the design of the balloon catheter for EHL and the EHL probe will likely increase the availability of fluoroscopically guided EHL. In conclusion, when patients are selected carefully, fluoroscopically guided EHL with a balloon catheter appears to be effective treatment for bileduct stones that cannot be extracted by using conventional techniques, including mechanical lithotripsy. When direct cholangioscopic control is not available or is limited, EHL with a balloon catheter may be an alternative. Because of the risk of serious complications, however, balloon catheter EHL should be limited to cases not amenable to conventional endoscopic methods. Controlled comparison trials with cholangioscopic lithotripsy will be necessary to determine the efficacy and cost-benefit ratio of fluoroscopically guided balloon catheter lithotripsy. GASTROINTESTINAL ENDOSCOPY
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ACKNOWLEDGMENTS We thank Mr. Andrei Suh, Nana Kook, RN, and the nursing staff of our digestive disease center for their support and assistance in developing the devices. REFERENCES 1. Sivak MV. Endoscopic management of bile duct stones. Am J Surg 1989;158:228-40. 2. Cotton PB. Endoscopic management of bile duct stones (apples and oranges). Gut 1984;25:587-97. 3. Sherman S, Hawes RH, Lehman GA. Management of bile duct stones. Semin Liver Dis 1990;10:205-21. 4. Cipoletta L, Costamagna G, Bianco MA, Rotondano G, Piscopo R, Mutignani M, et al. Endoscopic mechanical lithotripsy of difficult bile duct stones. Br J Surg 1997;84: 1407-9. 5. Sauerbruch T, Feussner H, Frimberger E, Hasegawa H, Ihse I, Riemann JF, et al. Treatment of common bile duct stones. A consensus report. Hepatogastroenterology 1994;41: 513-5. 6. Cotton PB, Kozarek RA, Schapiro RH, Nishioka NS, Kelsey PB, Ball TJ, et al. Endoscopic laser lithotripsy of large bile duct stones. Gastroenterology 1990;99:1128-33. 7. Neuhaus H, Hoffmann W, Zillinger C, Classen M. Laser lithotripsy of difficult bile duct stones under direct visual control. Gut 1993;34:415-21. 8. Binmoeller KF, Brueckner M, Thonke F, Soehendra N. Treatment of difficult bile duct stones using mechanical, electrohydraulic and extracorporeal shock wave lithotripsy. Endoscopy 1993;25:201-6. 9. Hochberger J, Bayer J, May A, Muehldorfer S, Maiss J, Hahn EG, et al. Laser lithotripsy of difficult bile duct stones: results in 60 patients using a rhodamine 6G dye laser with optical stone tissue detection system. Gut 1998;43:823-9. 10. Prat F, Fritsch J, Choury AD, Frouge C, Marteau V, Etienne JP. Laser lithotripsy of difficult biliary stones. Gastrointest Endosc 1994;40:290-5. 11. Schreiber F, Gurakuqi GC, Trauner M. Endoscopic intracorporeal laser lithotripsy of difficult common bile duct stones with a stone-recognition pulsed dye laser system. Gastrointest Endosc 1995;42:416-9. 12. Classen M, Hagenmu¨ller F, Knyrim K, Frimberger E. Giant bile duct stones-non-surgical treatment. Endoscopy 1988;20: 21-6. 13. Neuhaus H, Zillinger C, Born P, Ott R, Allescher H, Ro¨sch T, et al. Randomized study of intracorporeal laser lithotripsy versus extracorporeal shock-wave lithotripsy for difficult bile duct stones. Gastrointest Endosc 1998;47:327-34.
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14. Sauerbruch T, Holl J, Sackmann M, Paumgartner G. Fragmentation of bile duct stones by extracorporeal shock wave lithotripsy. A five-year experience. Hepatology 1992;15: 208-14. 15. Staritz M, Rambow A, Grosse A, Hurst A, Floth A, Mildenberger P, et al. Electromagnetically generated extracorporeal shockwaves for fragmentation of extra- and intrahepatic bile duct stones: indications, success and problems during a 15 months clinical experience. Gut 1990;31: 222-5. 16. Sackmann M, Holl J, Sauter GH, Pauletzki J, von Ritter C, Paumgartner G. Extracorporeal shock wave lithotripsy for clearance of bile duct stones resistant to endoscopic extraction. Gastrointest Endosc 2001;53:27-32. 17. Ell C, Hochberger J, May A, Fleig WE, Bauer R, Mendez L, et al. Laser lithotripsy of difficult bile duct stones by means of a rhodamine-6G laser and an integrated automatic stonetissue detection system. Gastrointest Endosc 1993;39:755-62. 18. Ponchon T, Gagnon P, Valette PJ, Henry L, Chavaillon A, Thieulin F. Pulsed dye laser lithotripsy of bile duct stones. Gastroenterology 1991;100:1730-6. 19. Silvis SE, Siegel JH, Katon RM, Hughes R, Sievert CE, Sivak MV. Use of electrohydraulic lithotripsy to fracture common bile duct stones. Gastrointest Endosc 1986;32: 155-6. 20. Bonnel DH, Liguory CE, Cornud FE, Lefebvre JFP. Common bile duct and intrahepatic stones: results of transhepatic electrohydraulic lithotripsy in 50 patients. Radiology 1991; 180:345-8. 21. Hixson LJ, Fennerty MB, Jaffee PE, Pulju JH, Palley SL. Peroral cholangioscopy with intracorporeal electrohydraulic lithotripsy for choledocholithiasis. Am J Gastroenterol 1992; 87:296-9. 22. Adamek HE, Maier M, Jakobs R, Wessbecher FR, Neuhauser T, Riemann JF. Management of retained bile duct stones: a prospective open trial comparing extracorporeal and intracorporeal lithotripsy. Gastrointest Endosc 1996;44:40-7. 23. Koch H, Rosch W, Walz V. Endoscopic lithotripsy in the common bile duct. Gastrointest Endosc 1980;26:16-8. 24. Siddique I, Galati J, Ankoma-Sey V, Wood RP, Ozaki C, Monsour H, et al. The role of choledochoscopy in the diagnosis and management of biliary tract diseases. Gastrointest Endosc 1999;50:67-73. 25. Siegel JH, Ben-Zvi JS, Pullano WE. Endoscopic electrohydraulic lithotripsy. Gastrointest Endosc 1990;36:134-6. 26. Bru¨ckner M, Grimm H, Soehendra N. Electrohydraulic lithotripsy of complicated choledocholithiasis. Endoscopy 1990;22:234-5.
VOLUME 60, NO. 4, 2004
Background: Electrohydraulic lithotripsy is a highly effective method for fragmenting biliary stones, but direct visual control is required. The efficacy and the safety of electrohydraulic lithotripsy without cholangioscopy by using a balloon catheter were evaluated in patients with bileduct stones that could not be extracted by using standard techniques. Methods: Nineteen patients with extrahepatic bile-duct stones that could not be extracted by using conventional endoscopic methods, e.g., mechanical lithotripsy, were selected to undergo electrohydraulic lithotripsy without peroral cholangioscopy. An electrohydraulic lithotripsy probe with a 3.0F radio-opaque tip was inserted through a balloon catheter. Electrohydraulic lithotripsy was performed under fluoroscopy until the fragmented stone could be captured in a large basket for mechanical lithotripsy. Endoscopic removal of the fragments was attempted during the electrohydraulic lithotripsy session. Results: Stones were successfully fragmented in 17 of 19 patients. In 16 patients (84.2%), the bile duct was cleared of all stones. A mean of 1.8 endoscopic sessions was required for complete removal. Additional mechanical lithotripsy was performed in 9 (56.2%) of the 16 patients. Minor complications were noted in 4 patients (2 hemobilia, 1 pancreatitis, 1 cholangitis). There was no 30-day mortality. Conclusions: For a selected group of patients with bile-duct stones not extractable by using standard techniques, fluoroscopically controlled electrohydraulic lithotripsy with a balloon catheter seems to be an effective method of fragmentation. (Gastrointest Endosc 2004;60:562-6.)
Currently, about 90% of patients with extrahepatic bile-duct stones are treated non-surgically by endoscopic sphincterotomy (ES) and stone extraction with a Dormia basket or by balloon catheter. With the addition of mechanical lithotripsy, the success rate for endoscopic stone extraction may reach 95%.1-4 However, these conventional endoscopic methods may fail when stones are firmly impacted, extremely large, and/or inaccessible because of anatomic problems, e.g., bile-duct stenosis. In such cases, additional methods are required, such as extracorporeal shock wave, intracorporeal Received December 19, 2003. For revision May 10, 2004. Accepted June 29, 2004. Current affiliations: Digestive Disease Center, Institute for Digestive Research, Soon Chun Hyang University College of Medicine, Seoul, Korea. This study was presented in part as an abstract at the annual meeting of the American Society for Gastrointestinal Endoscopy, May 20, 2003, Orlando, Florida (Gastrointest Endosc 2003;57:AB188). Reprint requests: Chan Sup Shim, MD, PhD, Digestive Disease Center, Soon Chun Hyang University Hospital, 657 HannamDong, Yongsan-Ku, Seoul 140-743, Korea. Copyright Ó 2004 by the American Society for Gastrointestinal Endoscopy 0016-5107/$30.00 PII: S0016-5107(04)02012-7 562
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electrohydraulic, or laser lithotripsy.5 Intracorporeal lithotripsy has the advantage that it can be applied during the initial endoscopic session. Electrohydraulic lithotripsy (EHL) uses high-pulse energy to disintegrate stones and has the advantage of being inexpensive; however, continuous visual control of the fragmentation process, via a ‘‘motherbaby’’ endoscope system, may be required for safety, because of the potential for accidental damage to the bile-duct wall.6,7 Because it requires two skilled endoscopists, cholangioscopy is available in only a few referral centers. Moreover, a peroral cholangioscope is expensive, fragile, and difficult to use.8-11 A balloon catheter was used for EHL in an effort to improve fluoroscopic targeting and to prevent damage to the bile-duct wall. Experience with this device system and method in patients with bile-duct stones that could not be extracted by using conventional methods is described. PATIENTS AND METHODS Patients Nineteen patients (11 women, 8 men; mean age 67 years, range 37-84 years) with extrahepatic bile-duct stones were included. Before EHL, at least one attempt at endoscopic extraction of the stones that included ES and mechanical VOLUME 60, NO. 4, 2004
Retained bile-duct stones treated by balloon catheter for lithotripsy
J Moon, S Cha, C Ryu, et al.
lithotripsy was made in all the patients. Stone removal by using conventional methods failed because of the inability to capture the stones in the basket for mechanical lithotripsy. The main reasons were the following: large stone size (6 patients) and stone impaction (13 patients). Four patients had biliary strictures. Nine (47.4%) had undergone cholecystectomy. Cholecystolithiasis was present in 5 patients (26.3%). In 78% of the patients, jaundice was the principal symptom that led to the diagnosis of stones. Nearly two thirds of the patients (62%) had pain in the upper abdomen, and, in third (33%), there were initial signs of cholangitis. Maximum stone diameter was measured on the retrograde cholangiogram before EHL (by using the diameter of the distal end of a standard duodenoscope as a reference to compensate for magnification). With respect to the largest stone in all patients, the mean diameter was 23 mm (range 16-42 mm); the mean number of stones was 2.6 (range 1-5). Exclusion criteria were coagulopathy and refusal to undergo EHL. When endoscopic stone extraction was unsuccessful, a nasobiliary catheter was inserted for biliary drainage and subsequent cholangiography. In two patients, percutaneous transhepatic biliary drainage (PTBD) was established at another institution. The study was approved by our institutional review board. Written informed consent was obtained from each patient for EHL. Methods Lithotripsy procedure. An electrohydraulic shock wave generator (Lithotron EL-27; Olympus Optical Co., Hamburg, Germany), set at an output of 2000 V, was used to generate shock waves of increasing frequency (intensity up to 500 mJ), which were applied as a continuous sequence of discharges. A balloon catheter was used to center the EHL probe on the stone and to avoid contact with the bileduct wall (Fig. 1). The lumen of a standard extraction balloon catheter (Wilson-Cook Medical Inc., WinstonSalem, N.C.), with an 18-mm-diameter balloon, was expanded to accommodate the 3.0F EHL probe. The catheter was 6.8F in diameter and 2 m in length. The 3m-long EHL probe, with a 3.0F radio-opaque tip (Olympus), was passed through the lumen of the modified balloon catheter. Extreme caution was exercised to avoid kinking of the probe. Then, the balloon catheter was inserted through the 3.2-mm-diameter accessory channel of a standard duodenoscope (JF-240; Olympus Optical Co., Ltd. Tokyo, Japan). The balloon catheter with EHL probe then was introduced into the bile duct. The tip of the balloon catheter was positioned near the stone, and the balloon was expanded. The tip of EHL probe was advanced a few millimeters beyond the radio-opaque tip of the balloon catheter under fluoroscopic guidance to ensure that the EHL probe was positioned on the stone surface. Fluoroscopy was used to target the stone and to monitor fragmentation. Lithotripsy was continued until the stones were sufficiently fragmented to allow capture in a large basket for mechanical lithotripsy (StoneBuster; GIP Medizintechnik GmbH, Achenmu¨hle, Germany). During EHL, the bile duct was continuously irrigated with VOLUME 60, NO. 4, 2004
Figure 1. Bile-duct stone and balloon catheter with electrohydraulic lithotripsy probe.
a mixture of contrast medium and saline solution. A fluid medium is required for generation of electrohydraulic shock waves. Irrigation also allowed visualization of stone fragments and clearing of debris from the duct. Bile was aspirated intermittently via the drainage tube and was inspected. Hemobilia was defined as any visible blood in the aspirate or duodenoscopic observation of blood flowing from the papillary orifice. Removal of stone fragments. After stone disintegration, endoscopic extraction of stones and fragments was attempted with a Dormia basket and balloon catheter during the EHL session. Mechanical lithotripsy was used if a stone fragment was still too large for basket or ballooncatheter extraction. The maximum duration time permitted for endoscopic stone removal was 45 minutes. If, at that time, ductal clearance was incomplete, a nasobiliary catheter was inserted, and antibiotics were administered. A further attempt to remove the stone fragments was made 3 days later. Failure of EHL was defined as the inability to achieve complete bile-duct clearance after a maximum of 3 lithotripsy sessions. Follow-up All the patients were followed for at least 2 days after the EHL. Follow-up included simple radiographs and laboratory tests (Hb, white blood cell count, bilirubin, alanine aminotransferase, aspartate aminotransferase, creatinine, GASTROINTESTINAL ENDOSCOPY
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Retained bile-duct stones treated by balloon catheter for lithotripsy
Figure 2. A, Cholangiogram showing stone impacted in bile duct with metal tip of EHL probe (arrow) in contact with stone; balloon (arrowhead) at end of balloon catheter has been expanded to position probe properly. B, Cholangiogram made during EHL, showing multiple stone fragments. C, Cholangiogram showing complete clearance of stones from bile duct.
serum urea nitrogen, amylase, lipase). The occurrence of a complication within 30 days of the final EHL was assessed by telephone interview or a patient visit.
RESULTS Lithotripsy Stone fragmentation by EHL without direct visual control was successful in 17 of 19 patients (89.5%) (Fig. 2). Stones could not be fragmented in two patients in whom positioning of the tip of the EHL probe on the stone was inadequate. One patient was later treated successfully by extracorporeal shock wave lithotripsy (ESWL). The other patient was treated palliatively by placement of a biliary endoprosthesis. Bile-duct clearance Complete duct clearance of stones was achieved in 16 of 19 patients (84.2%). Even though the stones were fragmented, complete removal was unsuccessful in one patient with a biliary stricture who was subsequently treated by the percutaneous transhepatic cholangioscopic approach. Of the 16 patients in whom ductal clearance was achieved, 6 (37.5%) underwent one endoscopic session, 8 (50%) required two sessions, and two (12.5%) had 3 sessions. The mean number of sessions needed for complete stone removal was 1.8 6 0.7. After EHL, 9 patients (56.2%) underwent mechanical lithotripsy to achieve sufficient fragmentation for complete stone clearance. 564
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Complications During EHL, transient hemobilia was observed in two patients. However, the bleeding stopped spontaneously after EHL, and transfusion was not required. Mild pancreatitis and cholangitis occurred in one patient each. All of these patients were treated conservatively after lithotripsy for 3 days in the hospital without further complication. DISCUSSION Standard endoscopic methods for removal of stones from the bile duct are unsuccessful in up to 5% to 10% of patients, because the stones are too large or are impacted.12 Even with mechanical lithotripsy, the failure rate is high in patients with stones 20 mm or more in diameter.4 Treatment of these patients requires the use of complementary techniques to achieve complete stone extraction. Stones difficult to extract can be removed by using a variety of methods. The effectiveness of intracorporeal and extracorporeal lithotripsy has been demonstrated in various studies. Extracorporeal and intracorporeal lithotripsy have comparable success rates of 70% to 98% in patients with bileduct stones resistant to extraction.13 ESWL, which has a high rate of successful fragmentation, extends non-surgical therapy for bile-duct stones to include extremely large stones.14-16 However, the stone fragments produced by ESWL frequently are too large for spontaneous passage, and, thus, further VOLUME 60, NO. 4, 2004
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endoscopic procedures are required to achieve complete ductal clearance.14,16 Because of the high cost of a lithotripter, ESWL is performed in relatively few centers. Success rates of 82% to 90% after a mean of 1.3 to 2.1 sessions are reported for intracorporeal laser lithotripsy (ILL).11,17 The efficiency and the safety of laser lithotripsy appear to be comparable with EHL performed under cholangioscopic guidance.7 ILL with a tissue-stone recognition system is potentially safer than EHL, which may result in hemobilia or bile-duct damage.8 However, it is difficult and time consuming to target stones by fluoroscopy for ILL, because the positions of the small-diameter tip and radiolucent laser fiber inserted through the catheter are invisible.18 Another major disadvantage of the laser system is high cost. Silvis et al.19 reported the first transpapillary EHL in abstract form in 1986. EHL has been shown to be effective for endoscopic removal of bile-duct stones that are difficult to extract by using readily available techniques.8,20-22 However, bile-duct perforation, because of direct contact between the probe and duct wall, has been reported after EHL.8,20,23 Thus, direct visual control is required for EHL, because the shock waves may damage the bile duct. Cholangioscopy plus saline solution irrigation is routinely performed during EHL.8 Continuous irrigation usually is achieved via a nasobiliary catheter introduced into the bile duct before EHL. However, cholangioscopy with a ‘‘mother-baby’’ endoscope system requires two experienced endoscopists and is available in only a few centers. Moreover, the peroral cholangioscope is fragile, and the initial cost of the instruments is high.24 Also, cholangioscopic guidance during EHL often is difficult when clouds of stone debris obscure the view despite irrigation via a nasobiliary catheter. The EHL probe currently available is more flexible and thinner than earlier versions and can be inserted through a modified balloon catheter 7F in diameter, which can be used in combination with a standard duodenoscope. The radio-opaque tip of an EHL probe is advanced from the balloon catheter and onto the stone under fluoroscopy. Siegel et al.25 described the technical aspects of EHL by using a similar system, although clinical details were not given, nor were details concerning the EHL probe and balloon catheter. They injected a mixture of contrast and saline solution before performing EHL. However, continuous bile-duct irrigation via a biliary catheter is needed to provide a fluid medium for effective generation and conduction of electrohydraulic shock waves, as well as clearing stone debris to maintain fluoroscopic visualization.26 Complete EHL fragmenVOLUME 60, NO. 4, 2004
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tation of a large stone seems to require a long period of time. During a prolonged application of EHL, contact with the bile-duct wall may occur, even when the balloon catheter is used to fix the position of the probe. Therefore, shorter application times are more satisfactory. The mean diameter of the largest stones in the present series was 23 mm. To decrease the application time, mechanical lithotripsy was used after initial stone fragmentation by EHL (56.2% of cases). Siegel et al.25 attempted complete fragmentation and subsequent clearance of the bile duct by EHL alone. EHL with a balloon catheter is recommended by us for use until the fragment size is such that mechanical lithotripsy can be used. In this way, the chance of a serious EHL-related complication can be decreased. A certain level of endoscopic skill is required to bring the balloon catheter with EHL probe into close proximity with the surface of a stone. If a stone is eccentric in position (e.g., Mirizzi syndrome), it is difficult to direct the probe, and the risk of perforation is substantially increased. Positioning of the balloon may be unsatisfactory in certain anatomic conditions, e.g., intrahepatic bile-duct stones or stones located proximally in a markedly tortuous, angulated bile duct. There is a concern during EHL for the possibility of serious complications, such as duct perforation or severe bleeding. There were only two minor episodes of bleeding in the present series, but the number of patients treated was relatively small. If EHL is widely adopted, more serious complications may be encountered. Therefore, EHL should be performed with caution by experienced biliary endoscopists. In addition, EHL is associated with a high level of exposure to ionizing radiation for the patient and the endoscopist. However, improvements in the design of the balloon catheter for EHL and the EHL probe will likely increase the availability of fluoroscopically guided EHL. In conclusion, when patients are selected carefully, fluoroscopically guided EHL with a balloon catheter appears to be effective treatment for bileduct stones that cannot be extracted by using conventional techniques, including mechanical lithotripsy. When direct cholangioscopic control is not available or is limited, EHL with a balloon catheter may be an alternative. Because of the risk of serious complications, however, balloon catheter EHL should be limited to cases not amenable to conventional endoscopic methods. Controlled comparison trials with cholangioscopic lithotripsy will be necessary to determine the efficacy and cost-benefit ratio of fluoroscopically guided balloon catheter lithotripsy. GASTROINTESTINAL ENDOSCOPY
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ACKNOWLEDGMENTS We thank Mr. Andrei Suh, Nana Kook, RN, and the nursing staff of our digestive disease center for their support and assistance in developing the devices. REFERENCES 1. Sivak MV. Endoscopic management of bile duct stones. Am J Surg 1989;158:228-40. 2. Cotton PB. Endoscopic management of bile duct stones (apples and oranges). Gut 1984;25:587-97. 3. Sherman S, Hawes RH, Lehman GA. Management of bile duct stones. Semin Liver Dis 1990;10:205-21. 4. Cipoletta L, Costamagna G, Bianco MA, Rotondano G, Piscopo R, Mutignani M, et al. Endoscopic mechanical lithotripsy of difficult bile duct stones. Br J Surg 1997;84: 1407-9. 5. Sauerbruch T, Feussner H, Frimberger E, Hasegawa H, Ihse I, Riemann JF, et al. Treatment of common bile duct stones. A consensus report. Hepatogastroenterology 1994;41: 513-5. 6. Cotton PB, Kozarek RA, Schapiro RH, Nishioka NS, Kelsey PB, Ball TJ, et al. Endoscopic laser lithotripsy of large bile duct stones. Gastroenterology 1990;99:1128-33. 7. Neuhaus H, Hoffmann W, Zillinger C, Classen M. Laser lithotripsy of difficult bile duct stones under direct visual control. Gut 1993;34:415-21. 8. Binmoeller KF, Brueckner M, Thonke F, Soehendra N. Treatment of difficult bile duct stones using mechanical, electrohydraulic and extracorporeal shock wave lithotripsy. Endoscopy 1993;25:201-6. 9. Hochberger J, Bayer J, May A, Muehldorfer S, Maiss J, Hahn EG, et al. Laser lithotripsy of difficult bile duct stones: results in 60 patients using a rhodamine 6G dye laser with optical stone tissue detection system. Gut 1998;43:823-9. 10. Prat F, Fritsch J, Choury AD, Frouge C, Marteau V, Etienne JP. Laser lithotripsy of difficult biliary stones. Gastrointest Endosc 1994;40:290-5. 11. Schreiber F, Gurakuqi GC, Trauner M. Endoscopic intracorporeal laser lithotripsy of difficult common bile duct stones with a stone-recognition pulsed dye laser system. Gastrointest Endosc 1995;42:416-9. 12. Classen M, Hagenmu¨ller F, Knyrim K, Frimberger E. Giant bile duct stones-non-surgical treatment. Endoscopy 1988;20: 21-6. 13. Neuhaus H, Zillinger C, Born P, Ott R, Allescher H, Ro¨sch T, et al. Randomized study of intracorporeal laser lithotripsy versus extracorporeal shock-wave lithotripsy for difficult bile duct stones. Gastrointest Endosc 1998;47:327-34.
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