European Journal of Radiology, 15 (1992) 45-48 0 1992 Elsevier Science Publishers B.V. All rights reserved. 0720-048X/92/$05.00
EURRAD
45
00267
Flushable stent-system for internal drainage in occlusive jaundice Jean M. Friedrich a, Peter Schnarkowski”, Karl H. Link b, Karl A. Schumacher a and Susanne Hoch” “Department of Diagnostic Radiology and bDepartment of General Surgery, Universityof Urn, Urn, Germany (Received
18 October
1991; accepted
after revision 3 December
Key words: Bile duct, stenosis or obstruction;
interventional
1991)
radiology
Abstract
The effectiveness of biliary stents may be reduced as a result of obstruction by tumor material, bile salts or detritus. To circumvent this problem we developed a prosthesis system, which allows flushing and repetitive radiological control via a subcutaneous port. Prostheses were implanted in 26 patients presenting with inoperable occlusive lesions of the bile duct. Patency was regularly monitored by checking the bilirubin and alkaline phosphatase levels and using port-cholangiography. Catheter function was easily maintained in 92% of the patients and ended upon malignancy related death. In case of dysfunction, drainage could generally be restored with intensive flushing. This new flushable stent-system was easily implantable, could be exchanged without renewed percutaneous transhepatic puncture and allowed flushing, external drainage, bile probes for bacteriological examinations and follow up cholangiography via the subcutaneous placed port. -
Introduction
Patients and methods
Internal bile drainage by endoprosthesis as required after bile duct obstruction, has gained increasing clinical acceptance as a palliative therapy for patients with biliary tree obstruction [l-7]. The success of this therapy has been limited by stent occlusion due to detritus or tumor growth. Even polyurethane stents, which show a lower rate of encrustation compared with other plastics generally tend to occlude after an interval of three months [ 8,9]. In the event that a conventional stent occludes, additional percutaneous transhepatic punctures must be performed, which are associated with high risks, particularly sepsis in the case of cholangitis and bleeding [6,10]. Therefore, we developed a system which provides permanent accessibility to the biliary system via a subcutaneous port. This system allows replacement of the prosthesis without repuncturing the liver; flushing of the stent and repetitive radiological imaging.
The Flush stent (Angiomed, Karlsruhe, Germany), comprises a polyurethane stent (9, 12 or i4F) with compressible baskets at both ends and a flexible catheter (9F) connected to the proximal end (Fig. 1). The catheter connects the stent with a subcutaneously placed port system (Braun, Melsungen, Germany). The installation procedure has two steps. First the bile was externally drained over 48-72 h and systemic antibiotic coverage was initiated. Then, after local anesthesia and general analgesia (pethidine), a straight tipped guide wire (0.035” Lunderquist) was introduced through the drainage tube, until the tip reached the duodenal lumen. The drain was then removed and the incision site dilated to accommodate a 9, 12 or 14 F sheath. The guide wire and the sheath were guided by fluoroscopy. The stent was then negotiated through the sheath until the distal end passed the stenotic region. At this point the sheath was retracted, allowing the distally attached basket to expand; with further retraction the proximally attached basket expanded. By pulling on the connected portcatheter, the stent was optimally positioned. The portcatheter was shortened, leaving a 5 cm loop which was
Correspondence to: Jean M. Friedrich,
MD, Department of Diagnostic Radiology, University of Ulm, SteinhbvelstraDe 9, 7900 Ulm, Germany.
4-l
functioning stents had to be replaced: one was replaced due to an undetermined malfunction, two were replaced because of tumor obstruction and one because of its location proximal to a sclerotic papilla. One stent had to be exchanged for a conventional stent due to bile reflux into the pleura, causing pleuritis. Examined bile was infected with mostly intestinal bacteria, probes showed: Klebsiella (7/26), Streptococcus viridans (6/26), Escherichia coli (5/26). In one patient Staphylococcus aureus and Clostridium perfringens were detected, the remainder were sterile. Except for E. coli and klebsiella, which were resistant to antibiotic treatment, specific antibiotic therapy temporarily eliminated pathogens from the bile. In all patients, except those with sclerosing cholangitis (Fig. 4), the serum bilirubin and alkaline phosphatase levels returned to normal after prosthesis implantation. Fig. 3. a. Port-cholangiography showing stem obstruction by detritus and mural incrustation. b. Patent stent lumen after flushing.
proximal to the papilla malfunctioned. Three of the eight stents which malfunctioned showed transitory blockage during acute cholangitis episodes and bile reflux but were kept patent by repetitive flushing with a maximum of 500 ml saline solution. Although in these three patients the ports had to be removed, the catheters and flush stents remained implanted. In the case of port removal, the catheter was threaded through a small skin incision and anchored with suture. The other five mal-
Fig. 4. a. Flush stent positioned proximal to papilla with catheter in left hepatic duct in patient with sclerosing cholangitis. b. Eight weeks later, demarcation of a large necrotic area in the confluence of the hepatic ducts due to a clinically non-diagnosed exacerbation of sclerosing cholangitis.
Discussion Surgery in patients with obstructive jaundice is associated with significant morbidity and high mortality [ 3,11,12]. A widely implemented alternative to surgery is percutaneous transhepatic decompression of the bile [ 14,151. duct [ 131 using conventional endoprostheses A major disadvantage in using conventional stents is not only a high occlusion rate, but also its irretrievability. The flush stent can be easily replaced or removed and allows flushing in the case of encrustation or occlusion. Its location and patency can be continually monitored by port-cholangiography. This port-catheterstent system provides the clinician with permanent accessibility to the biliary tree without the need to repuncture the liver. Prior to promoting bile drainage, a stent must be properly placed and secured [4]. With implanted conventional biliary stents the tip usually protrudes into the duodenal lumen to ensure endoscopic extraction if the need arises [9]. However, our experience shows that stents which extend into the duodenal lumen suffer an increased risk of failure. These stents are exposed to food particles and intestinal bacteria, which when refluxed cause ascending infections and subsequently occlusion. Since the flush stent is attached to a catheter it is possible to implant the stent proximal to the papilla, thus reducing the rate of stent dysfunction and complications, while still allowing stent exchange or removal. Lee et al. reported that six occluded conventional stents could not be removed transhepatically, but rather had to be extracted endoscopically [9]. Furthermore, the flush stent and bile ducts can be purged of detritus which may cause blockage and bile stasis, both of which encourage bacterial growth. Also, bile fluids can be
48
extracted in order to determine specific pathogens, which is necessary prior to proper antibiotic therapy. Along with proper positioning, the mean stem patency time is an extremely important criteria in assessing the success of treating obstructive jaundice with prostheses. The location and patency of the flush stent can be controlled using port-cholangiography. This method allows monitoring of malignancy progression and helps in the clinical assessment of the patient. In case of tumor growth into the basket of the flush stent replacing of the endoprosthesis by a longer stent was performed. Port-cholangiography is especially useful in evaluating sclerosing cholangitis, since significant changes in duct anatomy can only be demonstrated using this method while serum bilirubin and alkaline phosphatase levels may be misleading (fig. 4b). The best long-term results in this study were obtained with stents implanted proximal to the papilla in patients with stenotic processes of the upper hepatic biliary system. With duodenal placement, the risk of prosthesis malfunction is greater and therefore port infections are more likely to occur. In the event of a port infection, it is usually sufficient to remove only the port while the catheter and Flush Stent remain in place. In conclusion, this newly introduced port-catheter-stent system can be easily inserted and provides long patency with minimal discomfort to the patient. The Flush Stent can be seen as a viable alternative to other endoprostheses, especially the expandable metal endoprostheses [ 161. References Burcharth F. A new endoprosthesis for nonoperative intubation of the biliary tract in malignant obstructive jaundice. Surg Gynecol Obstet 1978; 146: 76-78. Coons HG, Carey PH. Large-bore, long biliary endoprostheses (biliary stents) for improved drainage. Radiology 1983; 148: 89-94.
3 Dooley JS, Dick R, Olney J, Sherlock S. Non-surgical treatment of biliary obstruction. Lancet 1979; ii: 1040-1044. 4 McLean GK, Burke DR. Role of endoprosthesis in the management of malignant biliary obstruction. Radiology 1989; 170: 961-967. 5 Mueller PR, van Sonnenberg E, Ferrucci JT. Percutaneous biliary drainage: technical and catheter-related problems in 200 procedures. AJR 1982; 138: 17-23. 6 Mueller PR, Ferrucci JT, Teplick SK, van Sonnenberg E, Haskin PH, Butch RJ. Papanicolaou N. Biliary stent endo: prosthesis: analysis of complications in 113 patients. Radiology 1985; 156: 637-639. Pereiras RV, Rheingold OJ, Huston D, Mejia J, Viamonte M, Chiprut RO, Schiff ER. Relief of malignant obstructive jaundice by percutaneous insertion of a permanent prosthesis in the biliary tree. Ann Intern Med 1978; 89: 589-593. Lammer J, Stoeffler G, Petek WW, Hofler H. In-vitro long term perfusion ofdifferent materials for biliary endoprostheses. Invest Radio1 1986; 21: 329-331. Lee MJ, Mueller PR, Saini S, Morrison MC, Brink JA, Hahn PF. Occlusion of biliary endoprostheses: presentation and management. Radiology 1990; 176: 531-534. 10 Ferrucci JT, Mueller PR, Harbin WP. Percutaneous transhepatic biliary drainage. Radiology 1980; 135: 1-13. 11 Greig JD, Krukowski ZH, Matheson NA. Surgical morbidity and mortality in one hundred and twenty-nine patients with obstructive jaundice. Br J Surg 1988; 75: 216-219. 12 Pain JA, Cahill CJ, Bailey ME. Perioperative complications in obstructive jaundice: therapeutic considerations. Br J Surg 1985; 72: 942-945. 13 Gunther RW. Perkutane Gallenwegsdrainage. In: Gunther RW, Thelen M., ed. Interventionelle Radiologie. Stuttgart: Thieme, 1988; 363-376. 14 LaBerge, JM, Doherty M, Gordon RL, Ring EJ. Hilar malignancy: treatment with an expandable metallic transhepatic biliary stent. Radiology 1990; 177: 793-797. 15 L’Hermine C, Paris JC, Chastanet P, Varlet P, Delemazure 0, Boudghene F, Wierez AM. Traitement palliatif des icteres neoplasiques par endoprothese transhepatique percutanee. J Radio1 1986; 67: 469-478. 16 Lammer J, Klein GE, Kleinert R, Hausegger K, Einspieler R. Obstructive jaundice: use of expandable metal endoprosthesis for biliary drainage. Radiology 1990; 177: 789-792.
EURRAD
45
00267
Flushable stent-system for internal drainage in occlusive jaundice Jean M. Friedrich a, Peter Schnarkowski”, Karl H. Link b, Karl A. Schumacher a and Susanne Hoch” “Department of Diagnostic Radiology and bDepartment of General Surgery, Universityof Urn, Urn, Germany (Received
18 October
1991; accepted
after revision 3 December
Key words: Bile duct, stenosis or obstruction;
interventional
1991)
radiology
Abstract
The effectiveness of biliary stents may be reduced as a result of obstruction by tumor material, bile salts or detritus. To circumvent this problem we developed a prosthesis system, which allows flushing and repetitive radiological control via a subcutaneous port. Prostheses were implanted in 26 patients presenting with inoperable occlusive lesions of the bile duct. Patency was regularly monitored by checking the bilirubin and alkaline phosphatase levels and using port-cholangiography. Catheter function was easily maintained in 92% of the patients and ended upon malignancy related death. In case of dysfunction, drainage could generally be restored with intensive flushing. This new flushable stent-system was easily implantable, could be exchanged without renewed percutaneous transhepatic puncture and allowed flushing, external drainage, bile probes for bacteriological examinations and follow up cholangiography via the subcutaneous placed port. -
Introduction
Patients and methods
Internal bile drainage by endoprosthesis as required after bile duct obstruction, has gained increasing clinical acceptance as a palliative therapy for patients with biliary tree obstruction [l-7]. The success of this therapy has been limited by stent occlusion due to detritus or tumor growth. Even polyurethane stents, which show a lower rate of encrustation compared with other plastics generally tend to occlude after an interval of three months [ 8,9]. In the event that a conventional stent occludes, additional percutaneous transhepatic punctures must be performed, which are associated with high risks, particularly sepsis in the case of cholangitis and bleeding [6,10]. Therefore, we developed a system which provides permanent accessibility to the biliary system via a subcutaneous port. This system allows replacement of the prosthesis without repuncturing the liver; flushing of the stent and repetitive radiological imaging.
The Flush stent (Angiomed, Karlsruhe, Germany), comprises a polyurethane stent (9, 12 or i4F) with compressible baskets at both ends and a flexible catheter (9F) connected to the proximal end (Fig. 1). The catheter connects the stent with a subcutaneously placed port system (Braun, Melsungen, Germany). The installation procedure has two steps. First the bile was externally drained over 48-72 h and systemic antibiotic coverage was initiated. Then, after local anesthesia and general analgesia (pethidine), a straight tipped guide wire (0.035” Lunderquist) was introduced through the drainage tube, until the tip reached the duodenal lumen. The drain was then removed and the incision site dilated to accommodate a 9, 12 or 14 F sheath. The guide wire and the sheath were guided by fluoroscopy. The stent was then negotiated through the sheath until the distal end passed the stenotic region. At this point the sheath was retracted, allowing the distally attached basket to expand; with further retraction the proximally attached basket expanded. By pulling on the connected portcatheter, the stent was optimally positioned. The portcatheter was shortened, leaving a 5 cm loop which was
Correspondence to: Jean M. Friedrich,
MD, Department of Diagnostic Radiology, University of Ulm, SteinhbvelstraDe 9, 7900 Ulm, Germany.
4-l
functioning stents had to be replaced: one was replaced due to an undetermined malfunction, two were replaced because of tumor obstruction and one because of its location proximal to a sclerotic papilla. One stent had to be exchanged for a conventional stent due to bile reflux into the pleura, causing pleuritis. Examined bile was infected with mostly intestinal bacteria, probes showed: Klebsiella (7/26), Streptococcus viridans (6/26), Escherichia coli (5/26). In one patient Staphylococcus aureus and Clostridium perfringens were detected, the remainder were sterile. Except for E. coli and klebsiella, which were resistant to antibiotic treatment, specific antibiotic therapy temporarily eliminated pathogens from the bile. In all patients, except those with sclerosing cholangitis (Fig. 4), the serum bilirubin and alkaline phosphatase levels returned to normal after prosthesis implantation. Fig. 3. a. Port-cholangiography showing stem obstruction by detritus and mural incrustation. b. Patent stent lumen after flushing.
proximal to the papilla malfunctioned. Three of the eight stents which malfunctioned showed transitory blockage during acute cholangitis episodes and bile reflux but were kept patent by repetitive flushing with a maximum of 500 ml saline solution. Although in these three patients the ports had to be removed, the catheters and flush stents remained implanted. In the case of port removal, the catheter was threaded through a small skin incision and anchored with suture. The other five mal-
Fig. 4. a. Flush stent positioned proximal to papilla with catheter in left hepatic duct in patient with sclerosing cholangitis. b. Eight weeks later, demarcation of a large necrotic area in the confluence of the hepatic ducts due to a clinically non-diagnosed exacerbation of sclerosing cholangitis.
Discussion Surgery in patients with obstructive jaundice is associated with significant morbidity and high mortality [ 3,11,12]. A widely implemented alternative to surgery is percutaneous transhepatic decompression of the bile [ 14,151. duct [ 131 using conventional endoprostheses A major disadvantage in using conventional stents is not only a high occlusion rate, but also its irretrievability. The flush stent can be easily replaced or removed and allows flushing in the case of encrustation or occlusion. Its location and patency can be continually monitored by port-cholangiography. This port-catheterstent system provides the clinician with permanent accessibility to the biliary tree without the need to repuncture the liver. Prior to promoting bile drainage, a stent must be properly placed and secured [4]. With implanted conventional biliary stents the tip usually protrudes into the duodenal lumen to ensure endoscopic extraction if the need arises [9]. However, our experience shows that stents which extend into the duodenal lumen suffer an increased risk of failure. These stents are exposed to food particles and intestinal bacteria, which when refluxed cause ascending infections and subsequently occlusion. Since the flush stent is attached to a catheter it is possible to implant the stent proximal to the papilla, thus reducing the rate of stent dysfunction and complications, while still allowing stent exchange or removal. Lee et al. reported that six occluded conventional stents could not be removed transhepatically, but rather had to be extracted endoscopically [9]. Furthermore, the flush stent and bile ducts can be purged of detritus which may cause blockage and bile stasis, both of which encourage bacterial growth. Also, bile fluids can be
48
extracted in order to determine specific pathogens, which is necessary prior to proper antibiotic therapy. Along with proper positioning, the mean stem patency time is an extremely important criteria in assessing the success of treating obstructive jaundice with prostheses. The location and patency of the flush stent can be controlled using port-cholangiography. This method allows monitoring of malignancy progression and helps in the clinical assessment of the patient. In case of tumor growth into the basket of the flush stent replacing of the endoprosthesis by a longer stent was performed. Port-cholangiography is especially useful in evaluating sclerosing cholangitis, since significant changes in duct anatomy can only be demonstrated using this method while serum bilirubin and alkaline phosphatase levels may be misleading (fig. 4b). The best long-term results in this study were obtained with stents implanted proximal to the papilla in patients with stenotic processes of the upper hepatic biliary system. With duodenal placement, the risk of prosthesis malfunction is greater and therefore port infections are more likely to occur. In the event of a port infection, it is usually sufficient to remove only the port while the catheter and Flush Stent remain in place. In conclusion, this newly introduced port-catheter-stent system can be easily inserted and provides long patency with minimal discomfort to the patient. The Flush Stent can be seen as a viable alternative to other endoprostheses, especially the expandable metal endoprostheses [ 161. References Burcharth F. A new endoprosthesis for nonoperative intubation of the biliary tract in malignant obstructive jaundice. Surg Gynecol Obstet 1978; 146: 76-78. Coons HG, Carey PH. Large-bore, long biliary endoprostheses (biliary stents) for improved drainage. Radiology 1983; 148: 89-94.
3 Dooley JS, Dick R, Olney J, Sherlock S. Non-surgical treatment of biliary obstruction. Lancet 1979; ii: 1040-1044. 4 McLean GK, Burke DR. Role of endoprosthesis in the management of malignant biliary obstruction. Radiology 1989; 170: 961-967. 5 Mueller PR, van Sonnenberg E, Ferrucci JT. Percutaneous biliary drainage: technical and catheter-related problems in 200 procedures. AJR 1982; 138: 17-23. 6 Mueller PR, Ferrucci JT, Teplick SK, van Sonnenberg E, Haskin PH, Butch RJ. Papanicolaou N. Biliary stent endo: prosthesis: analysis of complications in 113 patients. Radiology 1985; 156: 637-639. Pereiras RV, Rheingold OJ, Huston D, Mejia J, Viamonte M, Chiprut RO, Schiff ER. Relief of malignant obstructive jaundice by percutaneous insertion of a permanent prosthesis in the biliary tree. Ann Intern Med 1978; 89: 589-593. Lammer J, Stoeffler G, Petek WW, Hofler H. In-vitro long term perfusion ofdifferent materials for biliary endoprostheses. Invest Radio1 1986; 21: 329-331. Lee MJ, Mueller PR, Saini S, Morrison MC, Brink JA, Hahn PF. Occlusion of biliary endoprostheses: presentation and management. Radiology 1990; 176: 531-534. 10 Ferrucci JT, Mueller PR, Harbin WP. Percutaneous transhepatic biliary drainage. Radiology 1980; 135: 1-13. 11 Greig JD, Krukowski ZH, Matheson NA. Surgical morbidity and mortality in one hundred and twenty-nine patients with obstructive jaundice. Br J Surg 1988; 75: 216-219. 12 Pain JA, Cahill CJ, Bailey ME. Perioperative complications in obstructive jaundice: therapeutic considerations. Br J Surg 1985; 72: 942-945. 13 Gunther RW. Perkutane Gallenwegsdrainage. In: Gunther RW, Thelen M., ed. Interventionelle Radiologie. Stuttgart: Thieme, 1988; 363-376. 14 LaBerge, JM, Doherty M, Gordon RL, Ring EJ. Hilar malignancy: treatment with an expandable metallic transhepatic biliary stent. Radiology 1990; 177: 793-797. 15 L’Hermine C, Paris JC, Chastanet P, Varlet P, Delemazure 0, Boudghene F, Wierez AM. Traitement palliatif des icteres neoplasiques par endoprothese transhepatique percutanee. J Radio1 1986; 67: 469-478. 16 Lammer J, Klein GE, Kleinert R, Hausegger K, Einspieler R. Obstructive jaundice: use of expandable metal endoprosthesis for biliary drainage. Radiology 1990; 177: 789-792.
