Percutaneously Placed Biliary Stents in the Management of Malignant Biliary Obstruction D O N A L D P. H A R R I N G T O N , MD, K L E M E N S H. B A R T H , MD, W I L L I S C. M A D D R E Y , MD, S T E P H E N L. K A U F M A N , MD, and J O H N L. C A M E R O N , MD

The management of malignant obstruction of the biliary tree is difficult and often unsuccessful. Advances in the technique of percutaneous transhepatic catheterization have made possible the nonoperative internal drainage of obstructed lesions. We report successful decompression of ten patients with unresectable biliary neoplasms using percutaneously placed internal biliary stents.

Percutaneous transhepatic cholangiography (PTC) has b e c o m e widely accepted and utilized, especially since the introduction of the small diameter flexible Chiba needle. This advance has increased the safety of the procedure and with experience the rate of successful visualization of obstructed biliary ducts has markedly improved. At the present the biliary ducts can be visualized in virtually 100% of patients with dilated ducts and in approximately 80-85% of patients with normal-sized ducts (1-3). Predictable visualization of the biliary tree combined with our previous experience with manipulation of surgically placed biliary stents led us to attempt percutaneous decompression of obstructed biliary tracts (4). This approach may spare patients with advanced disease and limited life expectancy the need for major palliative surgery. MATERIALS AND METHODS Patients with clinical and laboratory evidence of obstrucManuscript received March 26, 1979; revised manuscript received June 15, 1979; accepted June 30, 1979. From the Russell H. Morgan Department of Radiology and Radiologic Sciences and the Department of Surgery and Medicine at the Johns Hopkins Medical Institutions, Baltimore, Maryland 21205. Address for reprint requests: Dr. Willis C. Maddrey, Department of Medicine, The Johns Hopkins Hospital, Baltimore, Maryland 21205.

tive jaundice at The Johns Hopkins Hospital are generally referred for diagnostic PTC. The method employed for PTC is based on the original description by Seldinger and modified by Okuda et al (5, 6). Medications prior to study consist of diazepam and meperidol. Patients are also placed on gentamicin and penicillin the night before the study (7). A lateral approach to the liver is generally used for both the diagnostic PTC and for stent placement. If drainage of the left duct is considered, a midline approach just below the sternum is used. The exact location of the percutaneous entrance site for biliary stenting is determined by the anatomy of the biliary tree demonstrated by PTC. An ideal duct is one which is large and has a straight course to the obstructed area. After the anatomy of the biliary tree has been defined, a second puncture of the ducts is accomplished using a larger sheath-type needle (18 or 20 gauge). Once the duct of choice has been punctured under fluoroscopic control, a variable-sized J torque wire is used for placement of the sheath catheter (8). After the sheath has been advanced to its fullest extent or to the level of the obstruction, a special stiffened shapable guidewire is employed to pass through the obstruction (Cook Catheter Co., Bloomington, Indiana 47401). When the wire has passed through the obstruction, either the sheath is passed through the obstruction over the guidewire or the sheath is removed and a specially modified polyethylene pigtail catheter (8 Fr) advanced over the guidewire into position (Cook Catheter Co., Bloomington, Indiana 47401). If difficulty is encountered with passage of the pigtail catheter through the liver parenchyma, the sheath is reintroduced and a solid wire with a 6-cm spring guidewire at the proximal end is used for maximum support through the liver substance (Cook

Digestive Diseases and Sciences, Vol. 24, No. 11 (November 1979) 0163-2116/79/1100-0849503.00/1 9 1979 Digestive Disease Systems, Inc.

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Digestive Diseases and Sciences, Vol. 24, No. 11 (November 1979)

M A N A G E M E N T OF BILIARY OBSTRUCTION

Fig 2. Case 2. (A) PTC demonstrating total obstruction of the common hepatic duct distal to the takeoff of the cystic duct (arrow) from carcinoma of the pancreas. A guidewire would not pass the obstruction until 48 hr after external biliary drainage. (B) Cholangiogram; drainage catheter partially in place. The catheter (arrows) was placed with some difficulty because of high resistance in the liver so that the tip of the catheter was just into the duodenum. Drainage was adequate but optimal positioning had not been achieved. (C) Optimal positioning of the drainage catheter. The drainage catheter (arrows) was advanced into optimal position 48 hr after the position in B was obtained. The catheter was easily advanced due to fibrous tract formation.

Catheter Co., Bloomington, Indiana 4740 I). The drainage catheter is then passed into the duodenum. The catheter has sideholes proximally which fit in the biliary tree and distally for drainage into the duodenum (Figure 2C). The catheter has a gentle loop in its distal portion, and proximally there is an a n g u l a t i o n of a p p r o x i m a t e l y 120~ This angulation ideally fits into the angle of the common bile duct and the duodenum (Figures 1A, 2C, 4C). Cholangiographic examination after placement is essential to confirm proper position. Visualization of the intrahepatic ducts and duodenum with a single injection of contrast material indicates proper positioning. Cholangiographic examination is then performed daily for two to three days to ensure a stable position. The catheter is initially secured with wire sutures but later can be secured with paper tape. Digestive Diseases and Sciences, Vol. 24, No. II (November 1979)

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HARRINGTON ET AL The catheter is maintained by twice-daily vigorous injections with 25 cc of bacteriostatic water. Replacement of the catheter has not been necessary in the short-term follow-up (up to six months) of the cases presented. From July 1, 1978, through February 1, 1979, ten stent catheters were placed in patients with malignant obstructive lesions of the biliary tree. These patients all presented with jaundice which was painless in all but one. Other signs and symptoms were acholic stools, anorexia, weight loss, and pruritus. Less frequent symptoms were nausea, vomiting, and fever with chills. There were five males and five females. Ages ranged from 45 to 91 years, and averaged 66 years.

Case Report Case 1. A 42-year-old female noted the insidious onset of painless jaundice accompanied by malaise, fever, and shaking chills seven months prior to her hospital admission. Exploratory laparatomy revealed a small neoplastic lesion obstructing the common bile duct 1 cm from the ampulla of Vater. After several further operative procedures, she was left with a choledochoduodenostomy but continued to be jaundiced and was referred for palliative biliary stenting. On admission the total bilirubin was 18.3 mg/dl, alkaline phosphatase 620 IU, SGPT 65 units/liter, SGOT 117 IU.* PTC revealed total obstruction of the common hepatic duct just beyond the bifurcation of the right and left hepatic ducts (Figure 1A). At surgery there were multiple metastases throughout both lobes of the liver. Two days after operation, percutaneous cannulation of the biliary tree was accomplished through the right hepatic duct without difficulty. First the guidewire, and then a Ring-modified pigtail catheter was easily passed through the tightly obstructed segment into the duodenum (Figure 1B). The bilirubin initially fell to 9 rag/ dl but then rose, over a two-week period, to 22.2 mg/dl in spite of adequate drainage of bile. The patient steadily deteriorated and died some two months later. Subsequent cholangiograms indicated continued function of the drainage tube, but the bilirubin remained elevated. Comments: The case illustrates an ideal situation for drainage with dilated ducts, a short incomplete stenosis, and a short common duct. This case further demonstrates that adequate drainage does not always ensure a drop in bilirubin. Case 2. A 91-year-old female had been well except for a slow decline in mental function for five years. Two weeks prior to admission she became bedridden and was unable to care for herself and one week before admission she was noted to be grossly jaundiced. The bilirubin on admission was 21.0 mg/dl, SGOT 82 IU, SGPT 56 units/liter, and alkaline phosphatase was 117 IU. Ultrasonic examination of the abdomen indicated a dilated common bile duct with a suggested mass in the head of the pancreas. Because of her age, clinical condition, and strong suspicion of an incurable neoplasm in the pancreas, PTC and stent were requested. PTC demonstrated the total occlusion of the common bile duct just distal to the cystic duct (Figure 2A). A 20-gauge polyethylene sheath was placed into the *Johns Hopkins Medical Institutions normal chemical values are SGOT 0-19 IU, SGPT 0-17 IU, alkaline phosphatase 10-32 IU, and bilirubin 0.3-1.1 mg/dl.

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biliary ducts and advanced to the point of obstruction. The guidewire could not be passed through the area of narrowing. Two days of external biliary drainage was allowed and on repeat examination the catheter had recoiled out of the biliary tree. After repositioning the catheter, the guidewire was easily passed through the area of obstruction but high resistance to catheter manipulation within the liver parenchyma was experienced. The catheter subsequently passed with difficulty just into the duodenum (Figure 2B) but this was not considered in an adequate catheter position. After a further 48 hr of drainage, the catheter was easily advanced to optimum position in the duodenum (Figure 2C). The patient's bilirubin dropped over four days from 22.5 mg/dl to 11 mg/dl. The patient tolerated the procedure well but deteriorated clinically over a two-week period. The level of the bilirubin was reduced to 5.6 mg/dl at the time of the patient's death. Comments: The patient demonstrates the difficulties that can be encountered in a totally obstructed segment. In addition there was marked resistance to catheter passage within the liver parenchyma. These difficulties are overcome by external drainage and tract formation. Case 3. A 58-year-old white male had a sigmoid colectomy for carcinoma of the colon in July 1977. Lymph nodes were negative and the liver was normal. Two weeks prior to admission, in January 1979 there was the'onset of painless jaundice, acholic stools, and pruritus. On admission the bilirubin total was 16.4 mg/dl; SGOT 112 IU; SGPT 117 units/liter, and alkaline phosphatase 313 IU. Ultrasound examination was suggestive of metastases to the right lobe of the liver. PTC demonstrated extensive encasement and narrowing of both the right and left hepatic ducts at the bifurcation. Cannulation of the right hepatic duct was performed and the specially stiffened guidewire was passed through the obstructed segment followed by the modified pigtail catheter which was placed into the duodenum (Figure 3A). Exploratory laporatomy confinned the diagnosis of metastic adenocarcinoma to the liver. The patient's bilirubin dropped rapidly with external drainage, but persistent episodic fevers and positive blood cultures were noted for several weeks. Ultrasonography of the liver showed no evidence of hepatic abscess, and it was believed that the obstructed left hepatic duct was the source of the fever. Cholangiographic examination demonstrated a high degree of left duct stenosis. On February 16, 1979, percutaneous puncture of the left hepatic duct from a subzyphoid position was accomplished and external catheter drainage established (Figure 3B). Total bilirubin fell to 3.5 mg/dl after adequate external drainage of the left hepatic ducts and internal drainage of the right hepatic ducts. The patient has had no difficulty with the catheter placement, and the episodic fevers have slowly subsided. The external drainage catheter was inadvertently dislodged one month after placement and replaced within 24 hr. Comments: In this patient separate drainage of the right and left hepatic ducts was necessary for control of infection. Case 4. A 46-year-old female noted the onset of painless jaundice, acholic stools, dark urine, and diffuse pruritus two months before admission. Laporatomy indicated a Digestive Diseases and Sciences, Vol. 24, No. 11 (November 1979)

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Fig 3. Case 3. (A, top) Postdecompression cholangiogram in a patient with metastases to the porta hepatis from the colon obstructing right and left hepatic duct. Right duct adequately decompressed internally (arrow heads right). External drainage tube left hepatic duct (arrow heads left). (B, bottom) Cholangiogram through the left sided external drainage catheter high grade stenosis left duct (arrow). Digestive Diseases and Sciences, Vol. 24, No. 11 (November 1979)

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HARRINGTON ET AL neoplasm at the junction of the right and left hepatic ducts. A T tube placed into the common duct drained the left hepatic duct with a decrease in jaundice and pain but because the patient continued with intermittent fever spikes and E. coli was cultured from both bile and blood, she was referred for surgical drainage of the obstructed right duct. The total bilirubin was 5 mg/dl and alkaline phosphatase 181 IU. A T-tube cholangiogram showed fil~ing of both the right and left hepatic ducts but high-grad~ stenosis of the right hepatic duct (Figure 4A). Cannulation of the fight hepatic ductal system was accomplished under fluoroscopic control and a guidewire was passed through the stenotic area into the left hepatic duct. Advancement down the common hepatic duct was not initially possible. External drainage was established for 48 hr in order to establish a tract (Figure 4B). The catheter was then withdrawn to the level of the bifurcation and a J torque wire was passed down the common duct parallel to the T tube. The drainage catheter was passed over the torque guidewire, and this wire was replaced with the specialized stiffened guidewire. A Ring catheter was passed easily into the duodenum (Figure 4C). The patient has done well, and her jaundice and fever have subsided. Some three months after insertion the internal drainage tube became obstructed in its distal portion, signified by leakage externally about the tube. Flow was restored after a guidewire was passed through the catheter. The patient is receiving radiation therapy and is doing well six months after tube placement. Comments: This patient represents the longest followup (6 months) and illustrates the need for patience in allowing a fibrous tract to form for subsequent catheter manipulation and the simplicity of managing a blocked drainage tube. DISCUSSION Operative biliary drainage in patients with nonpancreatic malignant obstructive lesions of the biliary tree has a mortality of approximately 20% which increases to 33% in pancreatic neoplasms (9, 10). There was no alternative method of therapy prior to the use of percutaneous biliary stenting. This method is best applied to those patients who are deemed inoperable based on age or unresectable tumors. A nonoperative method of biliary drainage is p r e f e r r e d in view of the m o r b i d i t y and postoperative recovery time coupled with a short life expectancy. Table 1 lists the causes of obstruction in the ten patients in this series. Surgical therapy TABLE 1. DIAGNOSIS OF OBSTRUCTIVE LESIONS

Diagnoses

No. o f patients

C a r c i n o m a of the pancreas B., , . i C o m m o n hepatic d u c t lie a u c t tumor 48 h o u r s Bilirubin decrease not c o m e n s u r a t e with extent of biliary drainage Difficulties in m a i n t e n a n c e o f catheter position Short t e r m < 48 h o u r s Difficulties o f m a i n t e n a n c e of catheter position L o n g term > 48 h o u r s Blockage of drainage catheter late

0 0 2 0 2

3

3 1

remains the primary therapy in patients with resectable lesions because of the possibility of cure. The percutaneous transhepatic approach is ideally suited for external and internal drainage of the biliary system. The first report of external biliary drainage was that by Ahlung et al in 1963 (11). His experience has been subsequently expanded with several large series reported by Tylen et al, Mori et al, and Nakayama et al (12-14). These drainage techniques have been satisfactory for both long and short-term decompression of the biliary tree but lack the advantages of surgical correction and/or palliation with internal drainage of bile into the bowel. The first report of successful internal drainage utilizing a percutaneous technique was by Molnar et al in 1974 (15). Ring et al and Pollock et al reported the use of a modified pigtail catheter with multiple side holes which was fitted to the biliary duodenal configuration and utilized a stiffened guidewire for passage of this catheter through the obstructed lesion (16, 17). We have adapted this method in our patients and were successful in all ten cases. All our stenting procedures are preceded by PTC. Important technical points include injection of contrast material through the needle rather than passive drainage bile or even active withdrawal of bile to identify when the needle is in a duct. A second important consideration is that the biliary tree be completely filled with contrast material to avoid overlooking an obstructed area (6). Ideally biplane fluor o s c o p y should be used but single-plane fluoroscopy with a rotating cradle or tube is acceptable. Specific difficulties with the stenting procedure can be encountered at several points (Table 2). In some patients with total biliary obstruction, the Digestive Diseases and Sciences, Vol. 24, No. 11 (November 1979)

MANAGEMENT OF BILIARY OBSTRUCTION

Fig 4. Case 4. (A) T-tube cholangiogram in a patient with a bile duct tumor at the bifurcation of the right and left biliary ducts. T tube is in the left hepatic duct (closed arrow). The right hepatic duct (open arrow head) is constricted but had been draining to the common duct. (B) Cannulation of the right hepatic duct with passage of the catheter through the area of narrowing and up the left hepatic duct. Drainage catheter marked with arrows. (C) 48 hours after drainage of the right and left lobes of the liver, manipulation of the catheter down the common hepatic duct parallel to the T tube which remained in place is illustrated in this cholangiogram. Adequate drainage of the right hepatic duct into the common duct is seen (arrow heads).

guidewire will not pass through the stenotic segment. In these patients this difficulty can be overcome by utilizing external drainage of the biliary tree for 48 hr, after which the guidewire will often pass easily through the obstruction. The reduction in pressure and dilatation of the biliary tree above the area of stenosis frequently relieves the stenosis. A second difficulty is in passage of the catheter over the guidewire and through the hepatic parenchyma. In the majority of our ten cases, this has been accomplished with little difficulty, but in Case 2 considerable resistance was encountered within Digestive Diseases and Sciences, Vol. 24, No. I1 (November 1979)

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the liver. Attempts to dilate the tracts with large catheters caused considerable pain and was not successful. The alternative method used in Case 2 was to place a small external drainage catheter into the biliary tree above the area of obstruction in order to form a tract in the liver parenchyma. After 2-3 days of external drainage, the regular stent catheter was easily manipulated through the liver substance. A further alternative in a cooperative patient is the use of the special stiffened solid wire with the first 6 cm of this wire spring guided so that it can be passed easily into the duodenum through a sheath. This device was used in the later patients and provides the proper support for catheter passage through the liver. Other technical considerations include the importance of proper position of the catheter to avoid obstruction of the ampulla of Vater. This is present if the pigtail is not reformed in the duodenum because only the end hole will drain. This type of obstruction should be apparent on the follow-up cholangiogram. In the cooperative patient simple taping of the stent is adequate after a tract has been established, but we suggest that the catheter be secured with wire suture tied over tape applied to the catheter. Frequent early checks of catheter position may be necessary because of initial catheter movement. Pain at the puncture site after placement of the percutaneous catheter is common in the first few days after catheter placement but subsides rapidly. Long-term placement up to six months has been well tolerated. On one occasion a patient returned after three months with external leakage from the cutaneous placement site. It was determined cholangiographically that the distal portion of the catheter was obstructed. A simple passage of the guidewire through the catheter cleared the catheter and stopped the external flow of bile. The major purposes of catheter placement are to drain the obstructed biliary tracts and reduce the hyperbilirubinemia. In two patients there was little drop in the serum bilirubin and we conclude that there was either considerable parenchymal damage secondary to the obstruction or extensive metastatic involvement within the liver. The fall in serum bilirubin is generally greatest in the first few days and then tapers off. This has been well demonstrated by the work of Hansson et al, in which external drainage was performed in a large group of patients (18). After two weeks of drainage the median level of serum bilirubin, initially 17 mg/dl,

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dropped to 5 mg/dl. In eleven patients a decrease to less than 3 mg/dl occurred after four weeks (18). The return of serum bilirubin to normal is slow and in some instances is not achieved because of biliary cirrhosis. It is our conclusion that these percutaneously placed internal biliary stents provide satisfactory and easily accomplished palliative relief for malignant obstruction of the biliary tree and is especially useful in patients with a short life expectancy.

REFERENCES 1. Pereiras RV Jr, Rheingold OH, Hutson 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 89:589-593, 1978 2. Ferrucci JT Jr, Wittenberg J, Sarno RA, Dreyfuss Jr.: Fine needle transhepatic cholangiography: A new approach to obstructive jaundice. Am J Roentgenol 127:403-407, 1976 3. Pereiras R Jr, Chiprut RO, Greenwald RA, Schiff ER: Percutaneous transhepatic cholangiography with the "skinny" needle. Ann Intern Med 85:562-568, 1977 4. Cameron JL, Gayler BW, Harrington DP: Modification of the Longmire procedure. Ann Surg 187:379-382, 1978 5. Seldinger SI: Percutaneous transbepatic cholangiography. Acta Radiol 253:1-134, 1966 6. Okuda K, Tanikawa K, Emura T, Kuratomi S, Jinnouchi S, Urabe K, Sumikoshi T, Kanda Y, Fukuyama Y, Musha H, Mori H, Shimokawa Y, Yakushiji F, Matsuura Y: Nonsurgical, percutaneous transhepatic cholangiography--diagnostic significance in medical problems of the liver. Am J Dig Dis 19:21-36, 1974 7. Saharia PC, Cameron JL: Clinical management of acute cholangitis. Surg Gynecol Obstet 142:369-372, 1976 8. Harrington DP: Technical note. Teflon sheath placement in the biliary tree using high torque J guidewire. Radiology (in press) 9. Buckwalter JA, Lawton RL, Tidrick RT: Bypass operations for neoplastic biliary tract obstruction. Am J Surg 109:100106, 1965 10. Feduska NJ, Dent TL, Lindenauer SM: Results of palliative operations for carcinoma of the pancreas. Arch Surg 103:330-334, 1971 11. Ahnlumg HO, Morales O: Gallgangsdranage efter prcutane transhepatiskcholangiografi. Svenska Lakartidn 60:36843691, 1963 12. Tylen U, Hoeveis J, Vang J: Percutaneous transhepatic cholangiography with external drainage of obstructive biliary lesions. Surg Gynecol Obstet 144:13-18, 1977 13. Mori K, Misumi A, Sugliyama M, Okabe M, Matsuoka T, Ishii J, Akagi M: Percutaneous transhepatic bile drainage. Ann Surg 185:111-115, 1977 14. Nakayama T, Ikeda A, Okuda K: Percutaneous transhepatic drainage of the biliary tract. Technique and results in 104 cases. Gastroenterology 74:554-559, 1978 Digestive Diseases and Sciences, Vol. 24, No. 11 (November 1979)

MANAGEMENT OF BILIARY OBSTRUCTION i5. Molnar W, Stockum AE: Transhepatic dilatation of choledochenterostomy strictures. Radiology 129:59-64, 1978 16. Ring EJ, Oleaga JA, Freiman DB, Husted JW, Lunderquist A: Therapeutic applications of catheter cholangiography. Radiology 128:333-338, 1978 17. Pollock TW, Ring ER, Oleaga JA, Freiman DB, Mullen JL,

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Rosato EF: Percutaneous decompression of benign and malignant biliary obstruction. Arch Surg 114:148-151, 1979 18. Hansson JA, Hoevels J, Simert G, Tylen U, Vang J: Clinical aspects of nonsurgical percutaneous transhepatic bile drainage in obstructive lesions of the extrahepatic bile ducts. Ann Surg 189:58-61, 1979

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Percutaneously placed biliary stents in the management of malignant biliary obstruction.

Percutaneously Placed Biliary Stents in the Management of Malignant Biliary Obstruction D O N A L D P. H A R R I N G T O N , MD, K L E M E N S H. B A...
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