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Endoscopic bilateral metal stent placement for malignant hilar stenoses: identification of optimal technique
Endoscopic bilateral metal stent placement for malignant hilar stenoses: identification of optimal technique Rémi Dumas, MD, Nicolas Demuth, MD, Martin Buckley, MD, Emmanuel Paul Peten, MD, Thierry Manos, MD, JeanFrançois Demarquay, MD, Patrick Hastier, MD, FrançoisXavier Caroli-Bosc, MD, Patrick Rampal, MD, Jean-Pierre Delmont, MD Background: The aim of this study was to identify factors that facilitate bilateral insertion of metal stents in malignant hilar stenoses, for which plastic stents often result in incomplete drainage and subsequent cholangitis. Methods: Between January 1994 and April 1998, we collected 45 cases of advanced (Bismuth stage II or higher) hilar malignant stenoses. The insertion technique was progressively modified and the success rate in the early period (1994 to 1995) was compared with that of a later period (1996) and the most recent period (1997 to 1998). Results: Overall success rate was 73.3% (33 of 45). The success rates for the three periods were 50%, 67%, and 88% (p = 0.008), respectively. Cholangitis occurred in 3 of the patients with unilateral stents compared with 1 with bilateral stents. Conclusion: We have described a technique for endoscopic insertion of bilateral metallic stents for malignant hilar stenoses that results in high (>88%) and reproducible success rates.
Primary malignancies of the bile ducts have been recognized since 18891 and hilar malignancy was first reported in 1957.2 Hilar lesions are commonly referred to as Klatskin tumors3 and are classified according to the degree of involvement of the adjacent bile ducts.4 A Bismuth type I lesion is a stenosis within the common hepatic duct, a type II lesion involves the right and left hepatic ducts, type III lesions involve either the right (type IIIA) or left (type IIIB) secondary intrahepatic ducts, and type IV lesions involve the secondary intrahepatic ducts bilaterally. With the advent of large-channel therapeutic duodenoscopes in 1982, endoscopic insertion of large-diameter plastic biliary endoprostheses became possible. The superiority of an endoscopic approach over surgical or percutaneous drainage of common bile duct strictures, in terms of short-term morbidity, has been suggested in three randomized trials.5-7 The major disadvantage of plastic endoReceived August 5, 1998. For revision November 19, 1998. Accepted August 26, 1999. From the Service d’Hépato-Gastroentérologie, Hôpital de l’Archet II, Centre Hopitalier Universitaire de Nice, France. Reprint requests: Rémi Dumas, MD, G.I. Endoscopie, 151 Route St. Antoine de Ginestière, 06202 Nice, Cedex 3, France. Copyright © 2000 by the American Society for Gastrointestinal Endoscopy 0016-5107/2000/$12.00 + 0 37/69/102528 334
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prostheses—obstruction in 30% of cases within 3 months and in up to 70% of cases after 6 months— has led to the introduction of expandable metal stents in the treatment of malignant biliary strictures. Because of their expanded diameter of up to 30F, these stents have a median patency of 9.8 months.8 Despite their higher initial cost, several studies have suggested that metal stents are more cost effective than plastic stents in patients with malignant common bile duct strictures who have a relatively longer life expectancy.9-13 Prosthetic palliation of patients with malignant hilar stenoses poses particular difficulties, especially in advanced lesions (type II lesions or higher). The risk of cholangitis after contrast injection into the biliary tree in cases where incomplete drainage is achieved is well known. Retention of contrast and subsequent segmental cholangitis is a risk associated with endoscopic attempts to treat advanced hilar lesions and this has prompted some to question the role of endoscopic drainage in this situation.14 Bilateral drainage is technically demanding and, because of difficulty in obtaining adequate drainage bilaterally, it has been suggested that unilateral drainage may be sufficient for palliation.15,16 However, drainage of both obstructed ductal systems has been strongly advocated and has been shown to significantly reduce the morbidity and mortality rate due to the decreased incidence of cholangitis and septicemia.17-19 Because of their non-occlusive wire mesh structure, which is less likely to result in an obstructive segmental cholangitis on the contra-lateral side, metal stents appear to be better suited than plastic prostheses for palliation of patients with malignant hilar strictures. In cases where an unilateral metal stent has been inserted and cholangitis develops in the contra-lateral lobe, a technique of introducing a second stent through the wire mesh of the first stent has been described.20 In two trials, metal stents (percutaneous insertion) were considered advantageous compared with plastic prostheses.21,22 Hitherto, exclusive endoscopic placement of bilateral metal stents has been considered difficult. In our unit, we have developed a protocol that has resulted in a highly effective and reproducible method of inserting bilateral metal stents in cases of advanced malignant hilar stenoses. The aim of this retrospective study was to highlight the materials and methods that, we believe, lead to optimal endoscopic insertion of metal stents. PATIENTS AND METHODS Between January 1994 and April 1998, a total of 3385 ERCPs were performed in our unit and 588 metal stents VOLUME 51, NO. 3, 2000
Optimal bilateral metal stent placement in malignant hilar stenoses
R Dumas, N Demuth, M Buckley, et al.
Figure 1. Retrograde cholangiogram showing guidewires placed in both the left and right biliary tree in a 65-year-old man with hilar liver metastases secondary to pancreatic carcinoma.
Figure 2. X-ray view of the two metallic stents after insertion in a 62-year-old woman with hepatic hilar metastasis from an unknown primary tumor (Bismuth II stage).
were inserted by one endoscopist (R.D.). It has been our policy to insert bilateral metal stents in cases with advanced (type II or higher) lesions where surgery with curative intent has been excluded. When bilateral placement fails, a unilateral metal stent is inserted, if possible. Because an optimal technique for bilateral placement has not been described, we have gradually modified the technique and materials that we use. In this study, we have included all patients with type II or greater lesions in whom bilateral metal stent insertion was considered. All patients received intravenous broad-spectrum antibiotics (piperacillin 4 gm and metronidazole 500 mg) at the time of endoscopy and for 48 hours afterward. When the hilar stenosis was identified at ERCP, contrast agent was not injected, if possible, past the lesion on either side until supra-tumoral access had been obtained by coiling the distal end of a guidewire in the lumen of a dilated duct above the stenosis (Fig. 1). Since 1994, we have introduced the following modifications to our technique: (1) use of a therapeutic videoduodenoscope with a large (4.2 mm) accessory channel and sphincterotomy after diagnosis of the nature of the obstruction; (2) initial insertion of bilateral semi-rigid hydrophilic guidewires with flexible tips (Jagwire; Microvasive Endoscopy, Boston Scientific Corp., Natick, Mass.); (3) ensuring that the guidewires were not
entangled (Fig.1); (4) preliminary bilateral dilatation of the stenoses using hydrostatic, guidewire-guided balloons (Max-Force, Microvasive), preceded if necessary by guidewire-guided bougie dilatation; (5) initial insertion and deployment of the left-sided prosthesis, followed by insertion of the right-sided prosthesis (Fig. 2); (6) the use of prostheses of sufficient length to traverse the papillary orifice after deployment (i.e., >9 to 10 cm); (7) the choice of prostheses, a flexible Wallstent (Rolling Membrane, Schneider Europe, Bülach, Switzerland) initially (on the left side) followed by a more rigid, straighter metal stent (Placehit Wallstent, Schneider) (on the right side). All patients were assessed for (1) successful deployment as judged by post-procedure expansion of the stents and immediate clearance of contrast material from the biliary tree and air within the biliary tree (assessed by plain film x-rays), (2) immediate procedure-related morbidity and mortality, and (3) the short-term clinical outcome. We compared the outcomes of attempted bilateral metal stent insertion during the early period of the study, 1994 to 1995 (group 1), with that of a later period, 1996 (group 2), and the most recent period, 1997 to 1998 (group 3), after all the modifications to the technique had been incorporated.
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The comparison of the ratios of independent samples was performed with the Fisher test (5% significance value).
Optimal bilateral metal stent placement in malignant hilar stenoses
Table 1. Diagnosis, grade of stenosis, and presentation of the 45 subjects Type of obstruction
RESULTS During the entire study period, bilateral metal stent insertion was attempted in 45 patients (28 men, mean age 72 years, range 44 to 87). Groups 1 to 3 consisted of 14, 6, and 25 patients, respectively. Their clinical presentation, underlying pathology and type of hilar lesion are shown in Table 1. For group 1, bilateral stents were inserted in 7 of 14 (50%) and a unilateral metal stent was placed in the remaining 7 patients. For group 2, bilateral stents were placed in 4 of 6 (67%) and a unilateral stent was placed in the remaining 2 patients. For group 3, bilateral stents were placed in 22 of 25 (88%) and a unilateral stent was placed in the remaining patients. The rate of successful placement of bilateral stents was significantly higher in group 3 (88%) compared with group 1 (50%) (p < 0.008). For patients in whom bilateral metal stents were placed (n = 33), adequate expansion of the stents was demonstrated in all cases. Two of these 33 patients had both stents placed above the level of the papilla. Both were Placehit Wallstents 100 mm in length. Six patients had one stent protruding into the duodenum. These patients had a Placehit Wallstent 100 mm in length on the right side and a Rolling Membrane Wallstent 111 mm in length on the left side. All patients (n = 25) with both stents protruding into the duodenum had similarly a Placehit in the right side and a Rolling Membrane on the left side. The distribution of the patients from three groups was as follow: in group 1, there were 2 patients who had none of the stents entering into the duodenum, 4 had one stent placed above the papilla, and 1 had both stents emerging from the papilla. In group 2, there were 3 who had both stents in the duodenum and 1 had one stent above the papilla. In group 3, there were 21 patients who had both stents in the duodenum and only 1 had one stent placed above the papilla. There was no procedure-related mortality. The relative success rate according to the degree of hilar tumoral involvement was as follows: in Bismuth type II strictures, 22 of 26 patients (85%) had successful bilateral stent insertion and in Bismuth type III/IV strictures, 11 of 19 patients (58%) had bilateral stent insertion. During short-term follow-up, cholangitis developed in 3 of 12 (25%) and 1 of 33 (3%) patients with unilateral and bilateral stents, respectively. Re-intervention (mean follow-up 34 336
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Diagnosis Cholangiocarcinoma (n = 27) Gallbladder carcinoma (n = 4) Liver mets (n = 10) Not classified (n = 4) Total (n = 45) Presentation Jaundice (n = 34) Cholangitis (n = 13) Non-specific (n = 2)
II
III
IV
15 2 8 1 26
10 2 2 2 16
2 0 0 1 3
18 6 2
13 6 0
3 1 0
weeks, range 1 to 106) was required in 3 of 12 (25%) and 1 of 33 (3%) of patients with unilateral and bilateral stents, respectively. Of the 3 patients with cholangitis and unilateral stents, 1 required a combined percutaneous-endoscopic (rendezvous) procedure (at 2 months), 1 was treated by percutaneous drainage, and 1 responded to systemic antibiotic therapy. The 1 patient with bilateral stents who developed cholangitis responded to antibiotics. One early distal migration of a metal stent occurred but re-intervention was not necessary. DISCUSSION Despite the theoretic advantages of endoscopically placed bilateral metal stents for palliation of patients with malignant hilar stenoses, the difficulty of insertion has, hitherto, limited their use. In this study, we demonstrated, for the first time, a technique that allows successful and reproducible endoscopic bilateral insertion of metal stents in cases of advanced malignant hilar stenoses. An obvious criticism of this study would be that the improved success rates observed during the later period were due more to experience with the procedure than the modifications that were introduced. The endoscopist who had performed the procedures had performed in excess of 6000 ERCPs and inserted approximately 450 metal-type stents before the commencement of the study. Despite this experience, successful insertion of bilateral metal stents was only achieved in 50% of cases during the early study period. After modifying the materials used and the technique, a dramatic improvement to a success rate of 88% was observed. We consider that the use of a therapeutic duodenoscope with a 4.2 mm accessory channel is essential and, if the procedure has been started with an alternative endoscope before knowledge of the diagnosis, we recommence with a therapeutic duoVOLUME 51, NO. 3, 2000
Optimal bilateral metal stent placement in malignant hilar stenoses
denoscope. Performing an adequate endoscopic sphincterotomy greatly facilitates the insertion of the second metal stent after deployment of the first stent. It also facilitates the general maneuvering of instruments such as the guidewires and hydrostatic balloons before stent placement. A critical factor, we believe, is the choice of guidewires. Hydrophilic guidewires are useful for negotiating difficult or tight strictures. However, if a highly flexible guidewire is used, subsequent positioning of the dilating balloons and stents becomes difficult. After using a variety of different guidewires, we have found that a hydrophilic, atraumatic guidewire with a hydrophilic flexible tip and a more rigid, Teflon body (we used a Jag-Wire, Microvasive) gave the best results. In addition, it is important to ensure that, when the second guidewire is inserted, it does not become entangled around the first guidewire as this will lead to subsequent difficulties when the stents are being deployed. When the bilateral guidewires are in place, they are secured at their point of exit from the endoscope by two endoscopy assistants and the location of each guidewire within the biliary tree is noted. We begin by cannulating the left ductal system as this is usually the more difficult. If problems are encountered, the guidewire is inserted into a sphincterotome or a catheter with a precurved tip and this facilitates selective cannulation. Once the guidewire has been inserted into the left biliary tree and its anatomy demonstrated by contrast injection, a guidewire is then inserted into the right biliary tree before any attempt to dilate the left-sided obstruction. It is important that bilateral guidewire access be obtained before dilatation as dilatation results in trauma to the stricture on the contra-lateral side and favors entry of a guidewire into the system that has been dilated. This makes subsequent passage of a guidewire into the undilated system extremely difficult. When cannulating the right biliary tree, we prefer to gain access to the right paramedian duct as it facilitates subsequent insertion of the second stent. When both sides have been cannulated, successive dilatation of the left and right sides is performed by using a hydrostatic balloon which is passed over the guidewire. If resistance is encountered, gradual bougie dilatation is performed to facilitate subsequent passage of the balloon. The angulation of the left biliary system away from the direction of the common hepatic duct makes stent deployment in the side more difficult and, accordingly, the left-sided stent is inserted first. We have found that a more flexible stent that will adapt and angulate according to the anatomy is required for the left side and for this purpose we use VOLUME 51, NO. 3, 2000
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a “Rolling Membrane” type Wallstent. It is essential that the distal end of this stent be in a transpapillary position after deployment as this greatly facilitates insertion of the second stent. Therefore relatively long stents (>10 to 11 cm) need to be used, depending on the underlying anatomy. When the first stent has been released, the second stent is passed over the guidewire and released on the right side. Because of the more direct path from the common hepatic duct to the right biliary tree, a more rigid stent delivery system is more suitable for this side. In addition, because of the presence of the deployed left-sided stent within the common bile duct, if a stent with a fragile delivery system is used, release of the second stent may be unsuccessful because of damage to the delivery device. Because of its relative rigidity and resistance to traumatic damage, we suggest that a “Placehit” Wallstent is ideal for use as the (second) right-sided stent. Its placement into the duodenal-end of the common bile duct is facilitated if the stent is passed over the guidewire in the 6 o’clock position at the papilla. Previous studies have demonstrated the advantages of metal stents over plastic stents in the palliation of patients with distal common bile duct strictures.9-12 It also appears that effective bilateral drainage of advanced hilar malignancies offers the best option for palliation.17-19,22 In this study, we have attempted for the first time to identify the optimal technique for the insertion of bilateral metal stents in patients with advanced hilar lesions. This procedure applies to patients whose hilar stenosis appears malignant and who are not candidates for surgery. Using this technique, we have consistently achieved successful deployment of bilateral stents in greater than 85% of cases with favorable morbidity rates. The small size of our study population does not allow for definitive conclusions. The reproducibility of this technique, its cost-effectiveness, and its effect on short-term quality of life and survival need to be assessed in future studies. Because of the relative rarity of this condition, multicenter trials may be required to clarify these issues. REFERENCES 1. Musser JH. Primary carcinoma of the gallbladder and bile ducts. Boston Med Surg J 1989;121:581-8. 2. Altemeier WA, Gall EA, Zinninger MM. Sclerosing carcinoma of the major intrahepatic bile ducts. Arch Surg 1957;75:450-5. 3. Klatskin G. Adenocarcinoma of the hepatic duct at its bifurcation within the porta hepatitis: an unusual tumor with distinctive clinical and pathologic features. Am J Med 1965;38: 241-7. 4. Bismuth H, Castaing D, Traynor O. Resection or palliation: GASTROINTESTINAL ENDOSCOPY
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6.
7.
8. 9.
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11.
12.
13.
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priority of surgery in the treatment of hilar cancer. World J Surg 1988;12:39-47. Andersen JR, Sorensen SM, Kruse A, Rokkjaer M, Matzen P. Randomised trial of endoscopic endoprostheses versus operative bypass in malignant obstructive jaundice. Gut 1989;30: 1132-5. Smith AC, Dowsett JF, Russel RC, Hatfield AR, Cotton PB. Randomised trial of endoscopic stenting versus surgical bypass in malignant low bile duct obstruction. Lancet 1994; 344:1655-60. Speer AG, Cotton PB, Russel RC, Mason RR, Hatfield AR, Leung JW, et al. Randomised trial of endoscopic versus percutaneous stent insertion in malignant obstructive jaundice. Lancet 1987;2:57-62. Libby ED, Leung JW. Prevention of biliary stent clogging: a clinical review. Am J Gastroenterol 1996;91:1301-8. Davids PHP, Groen AK, Rauws EAJ, Guidon J, Tytgat GNJ, Kee S, et al. Randomised trial of self-expanding metal stents versus polyethylene stents for distal malignant biliary obstruction. Lancet 1992;340:19-26. Kynrim K, Wagner HJ, Pausch J, Vakil N. A prospective randomised controlled trial of metal stents for malignant obstruction of the common bile duct. Endoscopy 1993;25:207-12. Carr-Locke DL, Ball TY, Brandabur J, Connors PJ, Cotton PB, Geenen JE, et al. Multicenter randomized trial of Wallstent biliary endoprostheses versus plastic stents [abstract]. Gastrointest Endosc 1993;39:310. Prat F, Chapat O, Ducot B, Ponchon T, Pelletier G, Fritsch J, et al. A randomised trial of endoscopic drainage methods for inoperable malignant strictures of the common bile duct. Gastrointest Endosc 1998;47:1-7. Lee JG, Leung JWC. Biliary stents-plastic or metal [editorial]. Gastrointest Endosc 1998;47:90-91.
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14. Ducreux M, Liguory C, Lefebvre JF, Ink O, Choury A, Fritsch J, et al. Management of malignant hilar biliary obstruction by endoscopy. Results and prognostic factors. Dig Dis Sci 1992; 17:778-83. 15. Mueller PR, Ferrucci JT, Van Sonnenberg E, Warshaw AL, Simeone JF, Cronan JJ, et al. Obstruction of the left hepatic duct: diagnosis and treatment by selective fine needle cholangiography and percutaneous biliary drainage. Radiology 1982;145:297-302. 16. Polydorou AA, Chisholm EM, Romanos AA, Dowsett JF, Cotton PB, Hatfield AR, et al. A comparison of right versus left hepatic duct endoprostheses insertion in malignant hilar biliary obstruction. Endoscopy 1989;21:266-71. 17. Devière J, Baize M, de Toeuf J, Cremer M. Long-term followup of patients with hilar malignant stricture treated by endoscopic internal biliary drainage. Gastrointest Endosc 1988;34: 95-101. 18. Motte S, Devière J, Dumonceau JM, Serruys E, Thys JP, Cremer M. Risk factors for septicemia following endoscopic biliary stenting. Gastroenterology 1991;101:1374-81. 19. Verduron A, de Loubens O, Girault F. Management of high grade hilar strictures (HGHS) by endoscopic insertion of two wallstent prostheses (WP) [abstract]. Endoscopy 1997;29:E48. 20. Neuhaus H, Gottlieb K, Classen M. The “stent through wire mesh technique” for complicated biliary strictures. Gastrointest Endosc 1993;39:553-6. 21. Wagner HJ, Knyrim K, Vakil N, Klose KJ. Plastic endoprostheses versus metal stents in the palliative treatment of malignant hilar biliary obstruction. A prospective and randomized trial. Endoscopy 1993;25:213-8. 22. Stoker J, Lameris JS, van Blankenstein M. Percutaneous metallic self-expandable endoprostheses in malignant hilar biliary obstruction. Gastrointest Endosc 1993;39:43-9.
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Primary malignancies of the bile ducts have been recognized since 18891 and hilar malignancy was first reported in 1957.2 Hilar lesions are commonly referred to as Klatskin tumors3 and are classified according to the degree of involvement of the adjacent bile ducts.4 A Bismuth type I lesion is a stenosis within the common hepatic duct, a type II lesion involves the right and left hepatic ducts, type III lesions involve either the right (type IIIA) or left (type IIIB) secondary intrahepatic ducts, and type IV lesions involve the secondary intrahepatic ducts bilaterally. With the advent of large-channel therapeutic duodenoscopes in 1982, endoscopic insertion of large-diameter plastic biliary endoprostheses became possible. The superiority of an endoscopic approach over surgical or percutaneous drainage of common bile duct strictures, in terms of short-term morbidity, has been suggested in three randomized trials.5-7 The major disadvantage of plastic endoReceived August 5, 1998. For revision November 19, 1998. Accepted August 26, 1999. From the Service d’Hépato-Gastroentérologie, Hôpital de l’Archet II, Centre Hopitalier Universitaire de Nice, France. Reprint requests: Rémi Dumas, MD, G.I. Endoscopie, 151 Route St. Antoine de Ginestière, 06202 Nice, Cedex 3, France. Copyright © 2000 by the American Society for Gastrointestinal Endoscopy 0016-5107/2000/$12.00 + 0 37/69/102528 334
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prostheses—obstruction in 30% of cases within 3 months and in up to 70% of cases after 6 months— has led to the introduction of expandable metal stents in the treatment of malignant biliary strictures. Because of their expanded diameter of up to 30F, these stents have a median patency of 9.8 months.8 Despite their higher initial cost, several studies have suggested that metal stents are more cost effective than plastic stents in patients with malignant common bile duct strictures who have a relatively longer life expectancy.9-13 Prosthetic palliation of patients with malignant hilar stenoses poses particular difficulties, especially in advanced lesions (type II lesions or higher). The risk of cholangitis after contrast injection into the biliary tree in cases where incomplete drainage is achieved is well known. Retention of contrast and subsequent segmental cholangitis is a risk associated with endoscopic attempts to treat advanced hilar lesions and this has prompted some to question the role of endoscopic drainage in this situation.14 Bilateral drainage is technically demanding and, because of difficulty in obtaining adequate drainage bilaterally, it has been suggested that unilateral drainage may be sufficient for palliation.15,16 However, drainage of both obstructed ductal systems has been strongly advocated and has been shown to significantly reduce the morbidity and mortality rate due to the decreased incidence of cholangitis and septicemia.17-19 Because of their non-occlusive wire mesh structure, which is less likely to result in an obstructive segmental cholangitis on the contra-lateral side, metal stents appear to be better suited than plastic prostheses for palliation of patients with malignant hilar strictures. In cases where an unilateral metal stent has been inserted and cholangitis develops in the contra-lateral lobe, a technique of introducing a second stent through the wire mesh of the first stent has been described.20 In two trials, metal stents (percutaneous insertion) were considered advantageous compared with plastic prostheses.21,22 Hitherto, exclusive endoscopic placement of bilateral metal stents has been considered difficult. In our unit, we have developed a protocol that has resulted in a highly effective and reproducible method of inserting bilateral metal stents in cases of advanced malignant hilar stenoses. The aim of this retrospective study was to highlight the materials and methods that, we believe, lead to optimal endoscopic insertion of metal stents. PATIENTS AND METHODS Between January 1994 and April 1998, a total of 3385 ERCPs were performed in our unit and 588 metal stents VOLUME 51, NO. 3, 2000
Optimal bilateral metal stent placement in malignant hilar stenoses
R Dumas, N Demuth, M Buckley, et al.
Figure 1. Retrograde cholangiogram showing guidewires placed in both the left and right biliary tree in a 65-year-old man with hilar liver metastases secondary to pancreatic carcinoma.
Figure 2. X-ray view of the two metallic stents after insertion in a 62-year-old woman with hepatic hilar metastasis from an unknown primary tumor (Bismuth II stage).
were inserted by one endoscopist (R.D.). It has been our policy to insert bilateral metal stents in cases with advanced (type II or higher) lesions where surgery with curative intent has been excluded. When bilateral placement fails, a unilateral metal stent is inserted, if possible. Because an optimal technique for bilateral placement has not been described, we have gradually modified the technique and materials that we use. In this study, we have included all patients with type II or greater lesions in whom bilateral metal stent insertion was considered. All patients received intravenous broad-spectrum antibiotics (piperacillin 4 gm and metronidazole 500 mg) at the time of endoscopy and for 48 hours afterward. When the hilar stenosis was identified at ERCP, contrast agent was not injected, if possible, past the lesion on either side until supra-tumoral access had been obtained by coiling the distal end of a guidewire in the lumen of a dilated duct above the stenosis (Fig. 1). Since 1994, we have introduced the following modifications to our technique: (1) use of a therapeutic videoduodenoscope with a large (4.2 mm) accessory channel and sphincterotomy after diagnosis of the nature of the obstruction; (2) initial insertion of bilateral semi-rigid hydrophilic guidewires with flexible tips (Jagwire; Microvasive Endoscopy, Boston Scientific Corp., Natick, Mass.); (3) ensuring that the guidewires were not
entangled (Fig.1); (4) preliminary bilateral dilatation of the stenoses using hydrostatic, guidewire-guided balloons (Max-Force, Microvasive), preceded if necessary by guidewire-guided bougie dilatation; (5) initial insertion and deployment of the left-sided prosthesis, followed by insertion of the right-sided prosthesis (Fig. 2); (6) the use of prostheses of sufficient length to traverse the papillary orifice after deployment (i.e., >9 to 10 cm); (7) the choice of prostheses, a flexible Wallstent (Rolling Membrane, Schneider Europe, Bülach, Switzerland) initially (on the left side) followed by a more rigid, straighter metal stent (Placehit Wallstent, Schneider) (on the right side). All patients were assessed for (1) successful deployment as judged by post-procedure expansion of the stents and immediate clearance of contrast material from the biliary tree and air within the biliary tree (assessed by plain film x-rays), (2) immediate procedure-related morbidity and mortality, and (3) the short-term clinical outcome. We compared the outcomes of attempted bilateral metal stent insertion during the early period of the study, 1994 to 1995 (group 1), with that of a later period, 1996 (group 2), and the most recent period, 1997 to 1998 (group 3), after all the modifications to the technique had been incorporated.
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The comparison of the ratios of independent samples was performed with the Fisher test (5% significance value).
Optimal bilateral metal stent placement in malignant hilar stenoses
Table 1. Diagnosis, grade of stenosis, and presentation of the 45 subjects Type of obstruction
RESULTS During the entire study period, bilateral metal stent insertion was attempted in 45 patients (28 men, mean age 72 years, range 44 to 87). Groups 1 to 3 consisted of 14, 6, and 25 patients, respectively. Their clinical presentation, underlying pathology and type of hilar lesion are shown in Table 1. For group 1, bilateral stents were inserted in 7 of 14 (50%) and a unilateral metal stent was placed in the remaining 7 patients. For group 2, bilateral stents were placed in 4 of 6 (67%) and a unilateral stent was placed in the remaining 2 patients. For group 3, bilateral stents were placed in 22 of 25 (88%) and a unilateral stent was placed in the remaining patients. The rate of successful placement of bilateral stents was significantly higher in group 3 (88%) compared with group 1 (50%) (p < 0.008). For patients in whom bilateral metal stents were placed (n = 33), adequate expansion of the stents was demonstrated in all cases. Two of these 33 patients had both stents placed above the level of the papilla. Both were Placehit Wallstents 100 mm in length. Six patients had one stent protruding into the duodenum. These patients had a Placehit Wallstent 100 mm in length on the right side and a Rolling Membrane Wallstent 111 mm in length on the left side. All patients (n = 25) with both stents protruding into the duodenum had similarly a Placehit in the right side and a Rolling Membrane on the left side. The distribution of the patients from three groups was as follow: in group 1, there were 2 patients who had none of the stents entering into the duodenum, 4 had one stent placed above the papilla, and 1 had both stents emerging from the papilla. In group 2, there were 3 who had both stents in the duodenum and 1 had one stent above the papilla. In group 3, there were 21 patients who had both stents in the duodenum and only 1 had one stent placed above the papilla. There was no procedure-related mortality. The relative success rate according to the degree of hilar tumoral involvement was as follows: in Bismuth type II strictures, 22 of 26 patients (85%) had successful bilateral stent insertion and in Bismuth type III/IV strictures, 11 of 19 patients (58%) had bilateral stent insertion. During short-term follow-up, cholangitis developed in 3 of 12 (25%) and 1 of 33 (3%) patients with unilateral and bilateral stents, respectively. Re-intervention (mean follow-up 34 336
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Diagnosis Cholangiocarcinoma (n = 27) Gallbladder carcinoma (n = 4) Liver mets (n = 10) Not classified (n = 4) Total (n = 45) Presentation Jaundice (n = 34) Cholangitis (n = 13) Non-specific (n = 2)
II
III
IV
15 2 8 1 26
10 2 2 2 16
2 0 0 1 3
18 6 2
13 6 0
3 1 0
weeks, range 1 to 106) was required in 3 of 12 (25%) and 1 of 33 (3%) of patients with unilateral and bilateral stents, respectively. Of the 3 patients with cholangitis and unilateral stents, 1 required a combined percutaneous-endoscopic (rendezvous) procedure (at 2 months), 1 was treated by percutaneous drainage, and 1 responded to systemic antibiotic therapy. The 1 patient with bilateral stents who developed cholangitis responded to antibiotics. One early distal migration of a metal stent occurred but re-intervention was not necessary. DISCUSSION Despite the theoretic advantages of endoscopically placed bilateral metal stents for palliation of patients with malignant hilar stenoses, the difficulty of insertion has, hitherto, limited their use. In this study, we demonstrated, for the first time, a technique that allows successful and reproducible endoscopic bilateral insertion of metal stents in cases of advanced malignant hilar stenoses. An obvious criticism of this study would be that the improved success rates observed during the later period were due more to experience with the procedure than the modifications that were introduced. The endoscopist who had performed the procedures had performed in excess of 6000 ERCPs and inserted approximately 450 metal-type stents before the commencement of the study. Despite this experience, successful insertion of bilateral metal stents was only achieved in 50% of cases during the early study period. After modifying the materials used and the technique, a dramatic improvement to a success rate of 88% was observed. We consider that the use of a therapeutic duodenoscope with a 4.2 mm accessory channel is essential and, if the procedure has been started with an alternative endoscope before knowledge of the diagnosis, we recommence with a therapeutic duoVOLUME 51, NO. 3, 2000
Optimal bilateral metal stent placement in malignant hilar stenoses
denoscope. Performing an adequate endoscopic sphincterotomy greatly facilitates the insertion of the second metal stent after deployment of the first stent. It also facilitates the general maneuvering of instruments such as the guidewires and hydrostatic balloons before stent placement. A critical factor, we believe, is the choice of guidewires. Hydrophilic guidewires are useful for negotiating difficult or tight strictures. However, if a highly flexible guidewire is used, subsequent positioning of the dilating balloons and stents becomes difficult. After using a variety of different guidewires, we have found that a hydrophilic, atraumatic guidewire with a hydrophilic flexible tip and a more rigid, Teflon body (we used a Jag-Wire, Microvasive) gave the best results. In addition, it is important to ensure that, when the second guidewire is inserted, it does not become entangled around the first guidewire as this will lead to subsequent difficulties when the stents are being deployed. When the bilateral guidewires are in place, they are secured at their point of exit from the endoscope by two endoscopy assistants and the location of each guidewire within the biliary tree is noted. We begin by cannulating the left ductal system as this is usually the more difficult. If problems are encountered, the guidewire is inserted into a sphincterotome or a catheter with a precurved tip and this facilitates selective cannulation. Once the guidewire has been inserted into the left biliary tree and its anatomy demonstrated by contrast injection, a guidewire is then inserted into the right biliary tree before any attempt to dilate the left-sided obstruction. It is important that bilateral guidewire access be obtained before dilatation as dilatation results in trauma to the stricture on the contra-lateral side and favors entry of a guidewire into the system that has been dilated. This makes subsequent passage of a guidewire into the undilated system extremely difficult. When cannulating the right biliary tree, we prefer to gain access to the right paramedian duct as it facilitates subsequent insertion of the second stent. When both sides have been cannulated, successive dilatation of the left and right sides is performed by using a hydrostatic balloon which is passed over the guidewire. If resistance is encountered, gradual bougie dilatation is performed to facilitate subsequent passage of the balloon. The angulation of the left biliary system away from the direction of the common hepatic duct makes stent deployment in the side more difficult and, accordingly, the left-sided stent is inserted first. We have found that a more flexible stent that will adapt and angulate according to the anatomy is required for the left side and for this purpose we use VOLUME 51, NO. 3, 2000
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a “Rolling Membrane” type Wallstent. It is essential that the distal end of this stent be in a transpapillary position after deployment as this greatly facilitates insertion of the second stent. Therefore relatively long stents (>10 to 11 cm) need to be used, depending on the underlying anatomy. When the first stent has been released, the second stent is passed over the guidewire and released on the right side. Because of the more direct path from the common hepatic duct to the right biliary tree, a more rigid stent delivery system is more suitable for this side. In addition, because of the presence of the deployed left-sided stent within the common bile duct, if a stent with a fragile delivery system is used, release of the second stent may be unsuccessful because of damage to the delivery device. Because of its relative rigidity and resistance to traumatic damage, we suggest that a “Placehit” Wallstent is ideal for use as the (second) right-sided stent. Its placement into the duodenal-end of the common bile duct is facilitated if the stent is passed over the guidewire in the 6 o’clock position at the papilla. Previous studies have demonstrated the advantages of metal stents over plastic stents in the palliation of patients with distal common bile duct strictures.9-12 It also appears that effective bilateral drainage of advanced hilar malignancies offers the best option for palliation.17-19,22 In this study, we have attempted for the first time to identify the optimal technique for the insertion of bilateral metal stents in patients with advanced hilar lesions. This procedure applies to patients whose hilar stenosis appears malignant and who are not candidates for surgery. Using this technique, we have consistently achieved successful deployment of bilateral stents in greater than 85% of cases with favorable morbidity rates. The small size of our study population does not allow for definitive conclusions. The reproducibility of this technique, its cost-effectiveness, and its effect on short-term quality of life and survival need to be assessed in future studies. Because of the relative rarity of this condition, multicenter trials may be required to clarify these issues. REFERENCES 1. Musser JH. Primary carcinoma of the gallbladder and bile ducts. Boston Med Surg J 1989;121:581-8. 2. Altemeier WA, Gall EA, Zinninger MM. Sclerosing carcinoma of the major intrahepatic bile ducts. Arch Surg 1957;75:450-5. 3. Klatskin G. Adenocarcinoma of the hepatic duct at its bifurcation within the porta hepatitis: an unusual tumor with distinctive clinical and pathologic features. Am J Med 1965;38: 241-7. 4. Bismuth H, Castaing D, Traynor O. Resection or palliation: GASTROINTESTINAL ENDOSCOPY
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