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Endoscopic biliary drainage
van Berkel, A.M.
Publication date
2003
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Citation for published version (APA):
van Berkel, A. M. (2003). Endoscopic biliary drainage.
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Long-termLong-term results of endoscopic
drainagedrainage of common bile duct
stricturesstrictures in chronic pancreatitis
D.L.. Cahen', A.M. van Berkel1, D. Oskam1, E.AJ. Rauws', G.J.. Weverling^, K. Huibregtse', MJ. Bruno1
Departmentt of Gastroenterology and Hepatology' and Departmentt of Clinical Epidemiology and Biostatistics* Academicc Medical Center, Amsterdam, The Netherlands
ABSTRACT T
Background:Background: Endoscopic stent therapy is an established treatment modality to resolve
postoperativee biliary strictures. Results regarding long-term outcome of biliary start-ingg in chronic pancreatitis (CP) are scarce.
Methods:Methods: All CP patients who underwent endoscopic biliary drainage of a benign
stric-turee in our hospital between 1987-2000, were included in this retrospective study.
Results:Results: Fifty-eight CP patients underwent biliary stenting (median age 54, 44 male).
Proceduree related mortality rate was 2 % and complication rate 4 %. Median follow-upp was 45 months (range 0-182). Endoscopic treatment was successful in 22 patients (388 %). Multivariate analyses identified presence of concomitant acute pancreatitis ass the only predictor of successful outcome. Sub-analysis of these 12 patients revealedd a success rate of 92 %, as opposed to 24 % in cases without acute inflam-mation.. In this latter group, continued stenting beyond a one year period almost neverr resulted in additional stricture resolvement.
Conclusions:VoiConclusions:Voi fibrotic biliary strictures due to CP, without evidence of concomitant
acutee inflammation, long-term success rate of endoscopic therapy is poor and only onee out of four strictures is resolved successfully. If stricture resolution has not occurredd after a one year period, surgery should be considered.
I N T R O D U C T I O N N
InIn chronic pancreatitis (CP), common bile duct <CBD) stenosis is a frequent compli-cation,, with a reported incidence of 10 to 30 96(1-4). CBD obstruction can develop fromm two distinct features; compression due to peri-ductal inflammatory swelling or fibroticc stricturing caused by chronic inflammation. A CBD stenosis may lead to cholestasis,, jaundice, recurrent cholangitis and secondary biliary cirrhosis(2,5). Inn the past, a surgical bilio-digestive anastomoses was the only treatment option for thesee patients, with considerable morbidity and mortality. For this reason, other treatmentt modalities were investigated as an alternative therapy. Endoscopic biliary stentingg was first introduced as a palliative treatment for malignant stenosis(6). In additionn it has become an established treatment to resolve benign postoperative bil-iaryy stricrures(7-9). I n analogy, biliary strictures due to CP are also treated by endo-scopicc stenting, but results regarding long-term outcome are scarce.
Althoughh short-term results are excellent with immediate relieve of cholestasis in almostt all cases, it remains unclear whether endoscopic stent placement can achieve definitee stricture resolution in CP, especially in case of tight fibrotic strictures. No prospectivee studies have been carried out. A number of retrospective studies describedd results of a limited number of patients with long term success rates rang-ingg from 10-95 %{io-i7).
InIn this study, we report on our experience in endoscopic treatment of biliary stric-turess complicating CP over the past 14 years. The aims of this study were to evalu-atee long-term results and to identify factors predictive of outcome.
988 ENDOSCOPIC BILIARY DRAINAGE
MATERIALSS A N D M E T H O D S
Patients Patients
Alll consecutive CP patients who underwent biliary stenting in our hospital between 19877 and 2000 were retrieved from an endoscopic database. Patients with pancreat-icc malignancy were excluded, as were patients with a stenosis caused by concre-mentss or pseudocysts. We evaluated technical success rate, complication rate and long-termm success rate of the stent therapy.
Technique Technique
Patientss were examined with a side viewing therapeutic endoscope in the left lateral positionn under conscious sedation with midazolam. In all patients a diagnostic cholangiogramm was obtained. The CBD stricture was identified as a significant stenosiss with prestenotic dilatation and/or delayed runoff of contrast. A flexible guidee wire was passed through the stricture, followed by a guiding catheter. A poly-ethylenee Amsterdam-type endoprosthesis (10 Fr) was inserted over the guiding catheterr to bridge the stenosis. As a rule the shortest possible stent was used. The decisionn for sphincterotomy was at the discretion of the endoscopist. If sphinctero-tomyy was performed, the patient was observed clinically for 24 hours.
Afterr three months, ERCP was repeated. The stent was removed and a cholan-giogramm was obtained to evaluate the stenosis. The stricture was considered suffi-cientlyy dilated if the stricture waist had disappeared, and/or a 6.5 Fr catheter could passs without resistance and rapid runoff of contrast was evident. If a significant stric-turee was still present, a new stent was inserted. Stents were exchanged electively everyy 3 months or when signs of stent dysfunction were present.
Follow-up Follow-up
Afterr stent removal, all patients were seen in the outpatient clinic at regular intervals forr clinical and laboratory examination. Follow-up information was obtained from hospitall charts and prospectively completed by written questionnaires send to the patientt as well as the attending physician.
Definitions Definitions
Treatmentt was considered 'Successful' if no signs of biliary obstruction developed afterr permanent stent removal. 'Treatment failure' was defined by any one or more off the following; 1. Severe procedure related complications resulting in death or need off surgery. 2. Failure of the stricture to resolve, resulting in the need of further ther-apyy (continued endoscopic stenting, metal stent insertion or surgery). 3. Recurrence off the stenosis for which treatment was necessary. 'End of follow-up' was defined as thee time of failure, death, or the end of the follow-up period in November 2002.
Statistics Statistics
Primaryy outcome parameters were success rate, complication rate and recurrence rate.. Secondary outcome parameters were identification of prognostic factors predic-tivee of a successful outcome. Quantitative data are expressed as medians with lower andd upper values. Logistic regression was performed to identify prognostic factors of outcome.. The level of statistical significance was set at p < 0.05. Multivariate analy-siss was performed using step-by-step logistic regression. All variables with a p value << 0.1 were considered for multivariate analyses.
RESULTS S
Fromm our endoscopic database, we identified 58 patients with CP that underwent endoscopicc stent therapy for a CBD stenosis; 44 male (76 %), with a median age of 544 years (range 19 - 83). Patient characteristics are summarised in Table 1. All patientss suffered from chronic pancreatitis with median disease duration of 23 months.. Alcohol abuse was the predominant cause of pancreatitis (64 %). Twelve CP patientss (21 %) had concomitant acute pancreatitis at time of drainage (defined as swellingg of the pancreatic head and peri-pancreatic infiltration on imaging studies). Cholestasiss was present in all patients. Jaundice was the leading clinical symptom in 266 (45 %).
ERCP ERCP
Sphincterotomyy was performed in 25 patients (43 %), 15 of which underwent pre-cut sphincterotomy.. Fourteen patients had already undergone a sphincterotomy during aa previous procedure. The pancreatic duct (PD) was canulated in 43 patients (74 %) andd in 14 a PD stenosis was present {24 %), for which three received a prosthesis.
CBDCBD drainage
Afterr the cholangiogram revealed the distal CBD stenosis, a ro Fr endoprosthesis wass placed successfully in all cases [Technical success rate 100 %). Median duration of drainagee was 274 days (range 3-2706 days). A median of two stent exchanges took placee during this period (range 0-17). Although nowadays some centres insert mul-tiplee stents in a sequential fashion, in this population, 53 (91 %) received a single endoprosthesis.. In the remainder five patients multiple stent insertion was applied, withh a maximum of three stents.
MorbidityMorbidity and mortality
Onee procedure related death was recorded (Mortality rate 2 %). This patient died of a cerebrall infarction, a day after surgical intervention for a duodenal perforation causedd by ERCP. In addition, procedure related complications occurred in two patientss (Procedure related complication rate 4 %); a mild flare-up of pancreatitis which wass treated conservatively, and a liver abscess which was surgically drained.
ï o oo ENDOSCOPIC BILIARY DRAINAGE
Stentt related complications were observed in 28 patients (Stent related
complication-raterate 50 %); stent occlusion occurred in 27 cases and in one case the stent dislocated.
Alll of these cases were successfully treated by stent exchange.
Long-termLong-term results
Mediann follow-up was 45 months (range 0-182) after stent insertion. Overall, endo-scopicc treatment achieved stricture resolution in 22 patients {Overall success rate 38
%)%) {Table 2). In three of these cases the cholangiogram still showed some residual
narrowingg of the CBD after stent extraction, but no signs of functional obstruction (easyy passage of a 6.5 Fr catheter and rapid runoff of contrast were present).
Duringg the follow-up period, five patients (9 %) died of unrelated causes with a stent stilll in situ. On average, stent insertion was continued for a three year period in these patients.. Therefore, endoscopic treatment was not considered successful. Furthermore, 299 patients (50 %), underwent additional treatment modalities because endoscopic stentingg failed to resolve the stricture. Seventeen of these patients (29 %) underwent bypasss surgery (hepatojejunostomy in 4 and choledochojejunostomy in 13 patients). In 122 patients (21 %), surgery was contraindicated or refused by the patient. A metal stent wass inserted in n and one patient is still treated with repeated plastic endoprosthesis exchanges.. Of the 22 patients that were successfully dilated, 18 (31 %) are still alive and nonee developed a recurrent stenosis after a median follow-up of 85 months.
Besidess presence of acute peri-pancreatic inflammation no other predictors of suc-cessfull outcome were identified with multivariate analyses {table 3). A sub-analysis off these 12 patients revealed a success rate of 92 % in this group, as opposed to only 244 % in the group without concomitant acute pancreatitis (Table 2).
Forr the group as a whole, a longer stent duration was not associated with a more suc-cessfull outcome. To shed more light on the required duration of stenting of fibrotic strictures,, we further analysed this subset of patients without signs of acute pancre-atitis.. As shown graphically {Figure 1), when stenting successfully resolved the stric-ture,, this was almost always accomplished after three stent exchanges. Because stentss were changed electively every three months, this covers a one year stenting period.. As seen in figure 2, continued stent insertion beyond this time, almost never leadd to additional stricture resolution.
DISCUSSION N
Approximatelyy 10 to 30 % of patients with chronic pancreatitis will develop a com-monn bile duct obstruction during the course of their disease(i-4). Accepted indica-tionss for drainage are cholestasis, jaundice, and cholangitis. Besides symptomatic relief,, prevention of secondary biliary cirrhosis is an important goal of treatment. Endoscopicc stenting is often chosen as the initial treatment for biliary strictures in CP,, in analogy with therapy for postoperative benign biliary strictures. In the latter case,, results of endoscopic stenting are favourable and treatment success is reported
inn the range of 43 to 83 % (y, 8, 11). This study evaluates whether these positive resultss can indeed be extrapolated to strictures caused by CP. It encompasses the experiencee of a large endoscopic unit and is one of the largest series to date, with a mediann follow-up of 45 months. Although this study is retrospective, all follow-up dataa were obtained prospectively from multiple sources.
Thee main finding of this study was that a differentiation should be made between CBD stenosess due to compression by an oedematous inflamed pancreas and fibrotic stric-tures.. In the first case, endoscopic treatment is highly successful because the obstruc-tionn is only temporal and resolves spontaneously when the inflammation subsides. On thee other hand, in true fibrötk sLrictures, endoscopic treatment resulted in permanent dilationn of only one out of four strictures. Furthermore, extending the duration of stent therapyy beyond a one-year period, has no additional benefit in this latter group. Thee lack of differentiation between fibrotic and non-fibrotic stenosis is probably the majorr explanation for the wide range of success rates reported earlier (from 10 to 95 %)(io-i7).. Inclusion of diverse aetiologies of the biliary stenosis is probably another explanation.. Vitale et al. for instance, also included strictures caused by stone dis-ease(i8). .
Accordingg to our results, morbidity and mortality of endoscopic treatment of CBD stricturess due to chronic pancreatitis is acceptable. Procedure related mortality rate wass 2 % in this study, which is in accordance with previous literature(io-i7). Importantly,, this death seemed related to the patient's co-morbidity and not to the proceduree itself.
Plasticc stent dysfunction remained a frequent long-term complication and occurred inn almost half of the patients despite elective three monthly stent exchanges. In some smalll series these complications are described less frequently{n-i3). However, the presentt data are in accordance with our own previously published data and thee largest reported series by Farnbacher et al. (10, 15). Although cumbersome for patients,, stent associated complications can usually be controlled safely by removal orr exchange of the plastic prosthesis. Preliminary reports indicate that in a selected groupp of patients in whom plastic stent therapy failed and surgery is contraindicat-ed,, metal expandable stents show favourable results(ic)).
AA possible way to improve the outcome of endoscopic stenting might be sequential insertionn of multiple plastic stents (e.g. insertion of as many stents possible at the firstfirst ERCP and increasing the number at subsequent procedures). This follows the assumptionn that aggressive stenting with multiple stents results in stronger radial dilationn forces leading to improved stricture resolution. In a small series of nine patientss this approach was successful in 44 % of patients(20,2i). Use of multiple stentss may also lower the incidence of stent obstruction.
Givenn the disappointing results of endoscopic stent therapy in fibrotic strictures, it iss questionable whether it should be considered an appropriate first-line therapy in CP.. On the one hand, one may argue that it does prevent surgery in one quarter of
io22 ENDOSCOPIC BILIARY DRAINAGE
patients.. On the other hand, it requires multiple invasive procedures, which in the endd will not result in stricture resolution in the majority of cases. When patients are treatedd endoscopically, results should be evaluated after a one-year period. If the stricturee has not resolved by this time, surgery should be considered. Furthermore, iff other pancreatitis related complications require intervention (i.e. pancreatic duct stenosis),, surgery might be considered at an even earlier stage, as in these cases suc-cessfull therapeutic endoscopy is even less likely.
Tablee 1. Patient and drainage characteristics. Patients Patients
Agee (median, years) Genderr Male Female e Causee of pancreatitis Alcohol l Stonee disease Divisedd pancreas Idiopathic c Other r Unknown n Durationn disease (median,, months) Concomitantt acute pancreatitis s Cholestasis s Jaundice e Sphincterotomy y Pancreaticc duct stenosis Numberr ERCP's (median' Durationn drainage
(median,, days)
Numberr stent exchanges
(median) ) Maximumm nr stents 1 > i i AllnAlln = s8 544 (19-85) 444 (76%) 144 (24 %) 377 (64%) 11 (2%) 11 (2%) 133 ( 2 2 % ) 22 (3%) 44 (7%) 233 ( 0 - 1 7 6 ) 122 (21 %) 588 (100%) 266 (45%) 255 (43%) 188 (31%) 33 (1-18) 274(33 ~ 2706) 22 (0 - 17) 533 (9i%) 55 (9) SuccessSuccess n = 22 (}8 %) 54 4 16 6 6 6 9 9 1 0 0 1 1 2 2 3 3 11 1 2 2 2 7 7 1 0 0 7 7 2 2 (19-85) ) (73%) ) (27%) ) (41%) ) (46%) ) (5%) ) (9%) ) (00 - 1 0 9 ) (500 %) ( 1 0 00 %) (322 %) (455 %) (322 96) ( 2 - 8 ) ) 160(666 - 2706) 0 0 2 0 0 2 2 ( 0 - 6 ) ) (91%) ) (9%) ) failurefailure n = 36 (62%) 54 4 28 8 8 8 aR R 1 1 1 1 3 3 1 1 2 2 59 9 1 1 36 6 19 9 15 5 11 1 3 3 320 0 2 2 33 3 3 3 (322 - 76) (78%) ) ( 2 2 % ) ) (78%) ) (3%) ) (3%) ) (8%) ) (3%) ) (6%) ) (11 -176) (33 %) ( 1 0 00 %) (533 %) (422 %) (311 96) (11 -18) (33 - 2623) (00 - 17) (92%) ) (8%) )
1044 ENDOSCOPIC BILIARY DRAINAGE
Tablee 2. Treatment failures; subdivided in fibrotic strictures and strictures caused by
periductall swelling due to concomitant acute pancreatitis (AP).
CauseCause of treatment failure All strictures n=n= 36 (62%)
Mortalityy 1 (2%) Morbidityy requiring surgery 1 (2%) Deathh with stent in situ 5 (9%) Insufficientt stricture resolvementt 29 (50%) FibroticFibrotic strictures n=n=3535((776%) 6%) 11 (2%) 11 (2%) 55 <n%) 288 (61%) StricturesStrictures due to AP n=n= 1 (8%) 00 (0%) 00 (0%) 00 (0%) 11 (8%)
Tablee 3. Multivariate analyses; prognostic factors of successful endoscopic drainage.
Variable Variable UnivariateUnivariate p value Multivariate p value OddsOdds ratio (95% CI) Odds ratio (gf/o CI)
Male e Agee < 54 yr. Acutee pancreatitis Acoholl abuse Sfincterotomy y Jaundice e Drainagee < 274 days 0.8 8 i-3 3 33 3 0.18 8 0.9 9 0.4 4 2 . 0 0 (0.22 - 2.5) (0.44 - 3.3) (4-00 - 333) (0.055 - 0.63) (0.33 - 2.5} (o.rr -1.3) (0.77 - 5.0) 0.66 6 0.74 4 O.OOI I 0 . 0 0 6 6 1.0 0 O.I2 2 0.2I I 333 (2-9-333) 0.211 (0.01 - 3.3) 3.11 (0.4-25) 0.005 5 0.28 8 0.30 0
Figuree 1. Figure 1: Number of stent exchanges in patients in whom biliary stenting
resultedd in successful resolution of fibrotic CBD stricture; n=n (24 %). Patients s
4 4
00 1 Numberr of stent exchanges
22 3 6 ->-- (exchanges unknown: n = 1)
Figuree 2. Number of stent exchanges in patients in whom biliary stenting failed to resolve
fibroticc CBD stricture: n= 35 (76 %).
111 12 13 17 Numberr of stent exchanges
i o 66 ENDOSCOPIC BILIARY DRAINAGE
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