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Endoscopic biliary drainage
van Berkel, A.M.
Publication date
2003
Link to publication
Citation for published version (APA):
van Berkel, A. M. (2003). Endoscopic biliary drainage.
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Self-expandableSelf-expandable metal stents
inin benign biliary strictures
duedue to chronic pancreatitis
A.M.. van Berkel, D.L. Cahen, D.J. van Westerloo, E.A.J.. Rauws, K. Huibregtse, M.J. Bruno
Departmentt of Gastroenterology and Hepatology
Academicc Medical Center, Amsterdam, The Netherlands
ABSTRACT T
Background:Background: In selected patients with chronic pancreatitis (CP) in whom
convention-all plastic stenting fails and who have a contraindication or refuse surgery, insertion off a biliary self-expandable metal stent (SEMS) might be a valuable treatment.
Methods:Methods: Between 1994 and 1999, thirteen CP patients received SEMS for benign
biliaryy strictures (mean age 56 years, 4 women and 9 men). The indication for SEMS placementt was: contraindication to surgery (n=io), presumed inoperable pancreatic carcinomaa (n=i), concomitant non-resectable lung cancer (n=i), rejected surgery (n=i).. Success of treatment was defined as adequate biliary drainage by SEMS ther-apy. .
Results:Results: Mean follow-up time was 50 months (range 6 days-86 months). Nine
patientss (69%) were successfully treated by SEMS therapy: a patent first SEMS (n=5),, a patent second SEMS inserted through the first SEMS (n=3), and one patent SEMSS after balloon cleaning. In four patients SEMS treatment was not successful (migrationn n=i, occlusion n=3). Mean SEMS patency was 60 months (95% CI 43 months-777 months). At 33 months the probability of adequate biliary drainage with SEMSS therapy was 75%.
Conclusion:Conclusion: SEMS therapy is safe and provides successful and prolonged biliary
drainagee in benign biliary strictures due to CP in whom surgical intervention is not possiblee or desirable.
I N T R O D U C T I O N N
Inn patients with chronic pancreatitis (CP) 10-30% develop symptomatic biliary stric-tures(i-3).. Endoscopic insertion of plastic stents provides excellent short-term results inn terms of relief of jaundice. Long-term results, however, are disappointing. First, long-termm stenting with plastic stents is limited by stent clogging which can only partlyy be avoided by elective stent exchanges{3,4). More importantly, after one year of stentt therapy up to 80% of patients have a persistent stenosis and need to undergo surgicall bypass (e.g hepaticojejunostomy)(4).
Theree is, however, a subset of patients in whom surgery is contraindicated because off an increased surgical risk due to concomitant portal hypertension or advanced car-diacc or pulmonary disease. Some patients reject surgery for fear of the operation. It iss in this highly selected group of patients that the use of self-expandable metal stentss (SEMS) might be a valuable treatment option, potentially precluding prob-lemss of stent clogging associated with conventional stents.
SEMSS have a larger diameter compared to conventional polyethylene stents {30 Fr versuss 10 Fr) and longer patency rates, which has been well documented in case of malignantt biliary obstruction^,6). Drawback of SEMS is the impossibility to remove themm once they are inserted, which withheld many clinicians to use them in cases withh benign strictures. Published data comprises case reports and small series, and resultss are contradictory with only limited follow-up data(7-i3).
1122 ENDOSCOPIC BILIARY DRAINAGE
Thee aim of this study was to evaluate the safety and long-term outcome of SEMS in aa selected group of patients with benign biliary strictures due to chronic pancreatitis inn whom surgical intervention is not possible or desirable.
PATIENTSS EN METHODS Patients Patients
Alll patients with CP who received a SEMS to relief obstructive jaundice due to a benignn biliary stricture between 1994 and 1999 were retrieved from an endoscopic database.. Data were collected retrospectively until the end of the follow-up period in Novemberr 2002.
Treatment Treatment
Iff after removal of the plastic biliary stent the cholangiogram showed a persistent distall bile duct stricture, a SEMS (Wallstent®, Schneider, Switzerland) was inserted usingg standard techniques described elsewhere (5). In all patients a 30 Fr 10 cm SEMSS was used which expands to 8-10 mm and shortens to 6.8 cm. No prophylac-ticc antibiotics were prescribed. If not already performed at a previous ERCP proce-dure,, biliary sphincterotomy was performed in all cases.
Follow-up Follow-up
Patientss were evaluated in the outpatient clinic every three to six months by means off clinical examination and laboratory tests. Ultrasonography was performed when-everr indicated by abnormal clinical or biochemical findings. In case of stent dysfunc-tion,, an ERCP was performed for confirmation SEMS obstruction and restore biliary floww by various means (see results). At the end of the follow-up period in November 2002,, all patients (or relatives in case of death) and their physicians were interviewed byy telephone.
Definitions Definitions
Successs of treatment was defined as adequate biliary drainage by a SEMS, including placementt of a second SEMS through the first in case of stent dysfunction of the lat-terr or cleaning of SEMS by means of saline flushing and balloon sweeping. Stent drainagee was considered to be successful if serum bilirubin dropped more than 20% withinn one week after stent insertion. If jaundice failed to resolve or if a patient developedd jaundice, cholangitis, or a combination of a flu-like syndrome and cholestasis,, an ERCP was performed to confirm obstruction of the stent. Stent paten-cyy represented the interval between the time of stent insertion and the time of re-ERCP.. Complications of ERCP and sphincterotomy were evaluated according to the criteriaa of Cotton{i4). The end of follow-up was defined as the time of removal of the SEMS,, death, or the end of the follow-up period in November 2002.
Statistics Statistics
Dataa are presented as means ( standard deviation). Patient survival and stent paten-cyy was calculated according to Kaplan-Meier. With this type of 'survival' analysis theree is a limitation in reporting the 50% (median) value when this value is not reachedd in case of a prolonged 'survival'. In such cases, the calculated mean is an underestimationn of the actual 'survival' (i.e. SEMS patency). For accurate data repre-sentationn the 75% value is reported. The Chi-square test was used for comparison of categoricall data. A p-value < 0.05 was considered statistically significant.
K Ë S L U L T S S
Patients Patients
AA total of 13 patients were identified from the endoscopic database, 9 men and 4 women,, with a mean age of 56 years (range 40-79 years) (Table 1). The cause of chronicc pancreatitis was alcohol abuse (n=8), pancreas divisum (n=i) and idiopathic (n=4).. All patients had been treated with conventional plastic stents before insertion off a SEMS (mean 6 stents, range 1-18). Indications for SEMS placement were: (rela-tive)) contraindication to surgery (e.g. portal hypertension) (n=io), presumed inoper-ablee pancreas carcinoma which after long-term follow-up turned out to be a benign stenosiss due to CP (n=i), no candidate for surgery because of concomitant non-resectablee primary lung malignancy (n=i), patient rejected surgery (n=i). Two patientss had undergone previous surgery of the pancreas (pancreaticojejunostomy n=i;; pancreatic tail resection with Roux-Y anastomosis n=i).
EarlyEarly results
Endoscopicc SEMS placement was successful in all patients. Sphincterotomy was per-formedd in one patient. All other patients had already undergone a sphincterotomy at previouss ERCP procedures.
Earlyy complications occurred in one patient: an initial optimal placed SEMS migrat-edd into the duodenum and was removed by a polypectomy snare after 6 days (Table 2). Elevenn days after stent removal this patient underwent a choledochoduodenostomy andd pancreaticojejunostomy and had an uneventful recovery. The 30-day mortality wass zero.
LateLate results
Ninee patients (69%) had adequate biliary drainage by SEMS therapy at the end of follow-up:: a patent first SEMS (n=5), a patent second SEMS inserted through the firstt SEMS (n=3), and one patient with a patent SEMS after cleaning by a balloon (Tablee 2).
InIn four of the five patients who were successfully treated by a patent first SEMS, the stentt remained patent after 80, 66, 43 and 39 months, respectively. One of these patientss developed a liver abscess in the left liver lobe 14 months after SEMS
place-1144 ENDOSCOPIC BILIARY DRAINAGE
mentt which was considered a late complication. Treatment consisted of antibiotics andd percutaneous drainage of the abscess. One patient died of an unrelated cause withh a patent SEMS 18 months after insertion.
Inn three patients a second SEMS was inserted through the first SEMS, after respec-tivelyy 65, 57 and 45 months. The second SEMS remained patent for a minimum durationn of 27, 34 and 13 months, respectively.
Inn one patient, the SEMS was cleaned by a balloon on three different occasions {8, n , andd 26 months) during which sludge and debris was removed. This patient died 48 monthss after SEMS placement due to pulmonary cancer with a patent SEMS.
InIn four patients SEMS treatment was not successful (31%). In one patient the SEMS migratedd into the duodenum 6 days after placement and was removed by a polypecto-myy snare as described earlier. This patient underwent a choledochoduodenostomy and pancreaticojejunostomyy and died 40 months later from an unrelated cause. In the remainingg three patients a polyethylene stent was inserted through the SEMS after 6, 255 and 33 months, respectively. One of these patients underwent a successful hepatico-jejunostomyy after 5 polyethylene stent exchanges due to stent clogging. In this patient thee SEMS remained in situ for 52 months after surgery without complications. Overalll mean follow-up was 50 months (range 6 days-86 months). At the end of the observationn period, three patients died of whom two with a patent SEMS in situ and onee patient with the removed SEMS. At 33 months the probability of adequate biliary drainagee with SEMS therapy was 75%. The calculated mean SEMS patency (Kaplan Meierr method) was 60 months (95% CI 43 months-77 months) (Figure 1).
DISCUSSION N
Inn this series of selected patients with benign biliary strictures due to chronic pan-creatitiss in whom surgical intervention was not possible or desirable, SEMS therapy providedd adequate biliary drainage in the majority of patients (69%) after a overall meann follow-up time of 50 months. The probability of adequate biliary drainage by meanss of SEMS therapy at 33 months was 75%.
Inn patients with chronic pancreatitis (CP) 10-30% develop symptomatic biliary stenoses(i-3).. If the biliary stenosis is due to compression by an edematous inflamed pancreaticc head or a pseudocyst, biliary obstruction will resolve if the inflammation subsidess or the pseudocyst is drained. If, however, biliary obstruction is caused by a fibroticc stricture due to repeated or ongoing inflammation, the obstruction will not resolvee spontaneously. In these cases, medical intervention is mandatory. The gold standardd treatment is surgical biliary diversion (e.g. hepaticojejunostomy). This has beenn challenged by endoscopic interventional therapy, but studies have now shown thatt complete resolution of a biliary stricture due to CP and permanent removal of standardd polyethylene stents is achieved in only 10-30% of patients(4J3,i5,i6). Continuedd stent therapy (>i year) is not regarded as a valid treatment option because
off the need of frequent elective stent exchanges (every 3 months) and the risk of repeatedd stent clogging with associated complications such as cholangitis and sec-ondaryy biliary cirrhosis. For these reasons, many institutions have adopted the poli-cyy to endoscopically stent a CP induced fibroric stricture for one year and refer the patientt for surgical biliary diversion in case of failure.
Theree is a subset of patients in whom surgery is contraindicated because of an increasedd surgical risk due to concomitant portal hypertension (in patients with CP) orr complicated cardiac or pulmonary disease. Some patients reject surgery for fear off the operation. It is in this highly selected group of patients that the use of self-expandablee metal stents (SEMS) might be a valuable treatment option, potentially precludingg problems of early stent clogging and frequent plastic stent exchanges. SEMSS have significantly longer patency rates compared to polyethylene stents in malignantt biliary obstruction^,6). This is mainly due to a larger diameter compared too conventional polyethylene stents (30 Fr versus 10 Fr). Theoretically, SEMS might performm better in benign strictures because, obviously, obstruction due to tumor ingrowthh does not occur. Drawback of SEMS is the impossibility to remove them oncee they are inserted, which, together with fear of complicating future surgical intervention,, withheld many clinicians to use them in cases with benign strictures. Althoughh SEMS have been successfully removed wire by wire, this seems neither practicall nor necessary(i7,i8,i9). In case of obstruction, standard polyethylene stents cann be inserted through the SEMS. So far, it has not been shown that a deployed SEMSS in the distal common bile duct complicates future surgical intervention and long-termm outcome. In our series, one patient underwent a hepaticojejunostomy withh a SEMS left in situ. This patient had an uneventful recovery and remains free off symptoms with the SEMS in situ 52 months after surgery.
Studiess on the use and outcome of SEMS in benign biliary strictures have shown contradictoryy results(7-i3). Most publications comprise of case reports. There are onlyy very few patient series with limited number of patients and follow-up time. Outcomess are difficult to compare because of differences in patient population (post-surgicall benign strictures versus CP induced benign stricture), the route of SEMS placementt (endoscopic versus percutaneously) and SEMS stent design.
Devieree and co-workers reported an overall SEMS patency rate of 90% in 20 patients withh benign biliary strictures due to CP after a mean follow-up of 33 months(7). Only 22 patients developed SEMS occlusion. They concluded that if SEMS occlusion occurs,, it does so within 6 months after insertion, because it was postulated that in thiss time interval abnormal intima hyperplasia occurs and becomes symptomatic. Macconii and co-workers reported on 18 patients with postsurgical strictures who weree treated by SEMS which were inserted percutaneously. The patency rate at 3 year follow-upp was 69%(8). Although obtained in a different patient population, these resultss are in agreement with our data. In another study with percutaneously insert-edd SEMS in a group of patients with miscellaneous causes of benign strictures, the mediann SEMS patency was 32 months(9).
n 66 ENDOSCOPIC BILIARY DRAINAGE
Thee cause of SEMS occlusion is not fully understood and seems multifactorial. O'Brienn and co-workers performed baby scope examination i year after SEMS inser-tionn and complete epithelialization of the metal stent was seen in all patients(12). Hyperplasticc biliary epithelium may be the result of localized trauma to the mucos-all layer triggered by the edges of the uncovered metal stent. If excessive intima hyperplasiaa causes SEMS obstruction, this might be overcome with the use of a cov-ering.. Until now, covered SEMS have only been used in malignant strictures with-outt showing any additional benefit because of tumor overgrowth(2o). Other experi-mentall strategies to re-establish biliary drainage in case of intima hyperplasia includee intraductal radiotherapy, photodynamic therapy or endoscopic diathermy {13,21,22).. A relatively new but fascinating observation is that some drug compounds appliedd as a coating on the metal meshes, such as sirolimus or paclitaxel, are effec-tivee in reducing neointimal tissue proliferation in intravascular stents (23). Bacterial adherencee may also play a role, followed by sludge and stone formation as was seen inn different studies(9,n,2i); re-canalisation was performed by lithotripsy or cleaning byy a balloon.
Onee of the limitations of our retrospective study is the fact that SEMS dysfunction wass treated at the endoscopists' discretion in various ways and not by protocol. Placementt of a second SEMS through an occluded SEMS was performed in three patients.. In all three patients the second SEMS remained patent until the end of the follow-upp period. In one patient the SEMS was cleaned on multiple occasions by a balloonn with favourable results. Clearly, SEMS occlusion in this patient was due to sludgee formation and debris and not to intima hyperplasia. Standard treatment in casee of SEMS obstruction in malignant stricture consists of placement of a polyeth-ylenee stent through the SEMS and this was performed in our study in three patients. Althoughh effective in establishing immediate drainage, the problems of frequent stentt occlusion remains and these patients underwent multiple polyethylene stent exchangess thereafter. It remains uncertain whether these patients would have been moree adequately treated with a second SEMS.
Inn conclusion, SEMS therapy is safe and provides successful and prolonged biliary drainagee in a selected group of patients with benign biliary obstruction due to CP in whomm surgical intervention is not possible or desirable. If the SEMS becomes obstructedd it should be evaluated at ERCP whether this is due to excessive intima hyperplasiaa or sludge formation. In the latter case only flushing with saline and cleaningg by a balloon should be performed. In case of the former the initial indica-tiontion for SEMS placement must be reconsidered. In case of a relative contraindication forr surgery, a surgical biliary diversion should be reconsidered. In all other cases placementt of a second SEMS through the first seems a valid alternative.
Tablee l. Characteristics of patients with benign biliary strictures due to chronic pancreatitiss receiving SEMS therapy (n=i3).
Meann age in years (range) Male/Female e
Etiology y Alcohol l Divisum m Idopathic c
Meann previous piastic stents Indicationn SEMS
Relativee contraindication (range) ) surgery y Presumedd inoperable pancrceatic cancer Otherr malignancy Refusedd surgery 566 (40-79) 9/4 4 8 8 1 1 4 4 66 (1-18) 1 0 0 1 1 1 1 1 1
Tablee 2. Outcome of SEMS therapy in patients with benign biliary strictures due to chronicc pancreatitis (n=i3).
Earlyy complications SEMSS migration 300 day mortality Latee complications liverr abscess Meann follow-up*
Meann adequate drainage by SEMS $* succesfull treatment
nott succesful treatment Overalll mortality
proceduree related nott procedure realated
1 1 0 0 1 1 500 months (66 days-86 months) 600 months
(66 days-80 months) [43 months-77 months] 9 9
4 4
0 0
3 3 55 Kaplan Meier method
i i 88 ENDOSCOPIC BILIARY DRAINAGE
Figuree l. Kaplan Meier plot for adequate biliary drainage by SEMS therapy in patients with benignn biliary strictures due to chronic pancreatitis (n=i3).
.9 9 , 8 , , .7 7 ,6 6 Patency y A A .3 3 ,2 2 ,1 1 0,0 0
"1 1
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