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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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AA prospective randomised trial of
tannenbaumtannenbaum type teflon coated
stentsstents versus polyethylene stents
forfor distal malignant biliary obstruction
A.M.. van Berkel, IX. Huibregtse, J.J.G.H.M. Bergman, E.A.J.. Rauws, M.J. Bruno, K. Huibregtse
Departmentt of Gastroenterology and Hepatology
Academicc Medical Center, Amsterdam, The Netherlands
1 1
ABSTRACT T
Objective:Objective: Stent clogging is a major limitation in the palliative treatment of malignant
biliaryy obstruction. Preliminary studies suggested improved duration of patency of a Tannenbaumm design stent with a stainless steel mesh and an inner Teflon coating (TTC).. We compared the patency of a TTC stent to conventional polyethylene (PE) stentt in a prospective randomised trial.
Methods:Methods: Between February 1998 and September 1998 we included 60 patients with
distall malignant bile duct obstruction. Diagnosis included carcinoma of the pan-creass (N=57) and ampullary cancer (N=3). There were 29 men 31 women with a mediann age of 77 years. Stent diameter (10 Fr) and length (9 cm) were similar but bothh stent design and material were different: a Tannenbaum design stent with a stainlesss steel mesh and an inner Teflon coating and an Amsterdam type Polyethylenee stent.
Results:Results: Sixty patients were evaluated; thirty in the TTC and thirty the PE group. Early
complicationss occurred in two patients in each group. Stent dysfunction occurred in eighteenn of TTC and twelve of PE stents. Median stent patency was 102 days for TTC andd 142 days for PE stents (p= 0.41). Median survival did not differ significantly for bothh treatment groups (TTC 121 days, PE 105 days). Stent migration, in all cases proximall into the common bile duct, occurred in 4 patients in the TTC group versus zeroo in the PE group (p=o.o38).
Conclusions:Conclusions: This study did not confirm improved patency of Tannenbaum type
Teflonn coated stents. Proximal migration prompts for additional design modifica-tions. .
I N T R O D U C T I O N N
Biliaryy stent insertion has become a standard palliative treatment for obstructive jaundicee caused by malignancy of the pancreas and biliary system. The standard plasticc stent currently used is the Amsterdam type polyethylene stent with a median patencyy of 3-6 months {1-5).
Changingg the properties of materials used in the manufacturing process of plastic stentss has been explored as a means to improve stent patency. In vitro studies per-formedd by our group have demonstrated a direct relation between the frictional coef-ficientt of a polymer and the amount of encrusted material (6). On these experimen-tall grounds, Teflon appears to be the best polymer for biliary stents.
InIn a non-randomised study Soehendra evaluated a Tannenbaum design Teflon stent andd showed a median stent patency of 15 months (7). Until now these encouraging resultss have not been confirmed in three multi-center randomised trials {8-10). A preliminaryy study by Abedi and co-workers suggested improved duration of patency off a Tannenbaum design stent with a stainless steel mesh between an inner Teflon coatingg and an outer polyamide layer (11). Mean stent patency was 134 days and no occlusionss were noted.
788 ENDOSCOPIC BILIARY DRAINAGE
Wee conducted a prospective randomised trial to compare the patency rate of a con-ventionall polyethylene stent (PE) to a Tannenbaum design stent with a stainless steel meshh between an inner Teflon coating and an outer polyamide layer (TTC) in patientss with an irresectable distal malignant bile duct stricture.
PATIENTSS A N D M E T H O D S
CriteriaCriteria for eligibility
Patientss were included if they had obstructive jaundice due to an irresectable malig-nancyy involving the distal bile duct without having undergone a previous drainage procedure.. Diagnosis of malignancy was based on clinical and imaging findings. No otherr therapy was used to relieve biliary obstruction during the study period. The studyy protocol was approved by the local ethics committee. All patients gave informedd consent prior to entry in the study.
Treatment Treatment
AA diagnostic ERCP was performed to assess biliopancreatic anatomy. When deep cannulationn was successful and cholangiography showed a distal common bile duct stricture,, patients were randomised. Randomisation was performed by computer generatedd random numbers in sealed envelopes. Stenting was carried out using standardd techniques (12).
Stentss were different in design and material but both were straight, 10 Fr wide, and 99 cm long. The conventional Amsterdam type Polyethylene stent has one side flap andd one side hole at each end (PBN Medicals, Denmark). The Tannenbaum design stentt has a thin stainless steel mesh between an inner Teflon coating and an outer polyamidee layer without side holes and four side flaps at each end that do not pene-tratee the lumen of the stent (Olympus, Tokyo, Japan).
Follow-upFollow-up and definition of end points
Patientss were interviewed by telephone at monthly intervals until stent obstruction, death,, surgical treatment or the end of the follow-up period in April 1999. 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. Subsequent treatmentt consisted of exchange of the occluded stent by insertion of a polyethylene stentt or a self-expandable metal stent.
Stentt patency represented the interval between the time of stent insertion and the timee of its replacement or the presence of both jaundice and fever at the time of death.. Complications of ERCP and sphincterotomy were evaluated according to the criteriaa of Cotton (13).
StatisticalStatistical analysis
Patientt survival and stent patency were analysed by means of the Kaplan-Meier methodd and compared using the log-rank test. The Chi-square test was used for comparisonn of categorical data. All tests were two-tailed and p-values <o.o5 were consideredd statistically significant.
RESULTS S
PatientPatient enrolment and characteristics
Betweenn February 1998 and September 1998, 60 consecutive patients were includ-edd in the study. Fifty-seven patients had pancreatic cancer and three had ampullary cancer.. There were 29 men and 31 women with a median age of 77 {range 43-92 years).. Thirty patients were randomised to a TTC stent and thirty to a PE stent. Patientt characteristics were comparable between the two groups (Table 1).
EarlyEarly Results
Stentt insertion was successful in all patients. Procedure-related complications occurredd in 4 patients: perforation in one (PE), haemorrhage in three (TTC 2, PE 1). Alll complications were graded as mild. The patient who suffered a perforation (PE) recoveredd uneventfully after conservative therapy. All three haemorrhages occurred duringg precut papillotomy and were successfully treated by sclerotherapy without thee need for blood transfusion. There was no significant difference in the occurrence off procedure-related complications between the two groups.
Biliaryy drainage was successful in 53 patients (88%). Seven patients had no decline off bilirubin >20% of the pre-procedure value within one week after stent insertion. Inn three of these patients a repeat ERCP and a stent exchange (to PE stent) were per-formedd (TTC 3). Two patients died respectively 9 and 13 days after the procedure withoutt intervention (TTC 2). In the remaining two patients jaundice slowly sub-sidedd without intervention (TTC 1, PE 1).
LateLate results
Stentt occlusion occurred in 30 patients (50%) (Table 2). An ERCP was performed in 233 patients; the remaining 7 were considered unfit for further treatment. Median stentt patency was 102 days (range 4-264, 95% CI 36-168) in the TTC group and 142 dayss (range 7-277, 95% CI 32-252) in the PE group (Figure 1). There was no signifi-cantt difference in stent patency between the two groups (p=o.4i).
Stentt migration, in all cases proximally into the common bile duct, was noted in 4 patientss (13%) in the TTC group. In two patients the stent could not be removed after severall attempts and a second stent was placed through the stenosis alongside the proximallyy migrated stent to ensure adequate drainage. In the remaining patients thee stent could be removed by a dormia basket after papillotomy and a PE stent was insertedd afterwards. In the PE group no stents were found to have migrated. There
8oo ENDOSCOPIC BILIARY DRAINAGE
wass a significant difference in the incidence of stent migration between the two groupss (p=o.o38).
Mediann patient survival was 121 days in the TTC group and 105 days in the PE group (p=o.28). .
DISCUSSION N
InIn vitro studies have suggested that both material as well as design may affect stent
patency.. For example, stents made of Teflon have a lower friction coefficient than otherr plastics and therefore seem more suited to prevent stent blockage (6). With respectt to stent design it has been shown, both in vitro and in vivo, that convention-all polyethylene stents with side holes accumulate significantly more sludge than stentss from the same material without side holes (6;io).
Dataa from clinical studies regarding these issues are not convincing and in fact con-tradictory.. Soehendra and co-workers developed a Teflon stent without side holes, whichh they refer to as the Teflon Tannenbaum stent. The results from their non-ran-domisedd trial indicate a prolonged patency rate {7). From this study design it could nott be inferred whether the absence of side holes, the Teflon material or both were responsiblee for these encouraging initial results. Two other studies looking at each itemm individually did not provide more insight in this matter. Sung and co-workers comparedd in a randomised trial a conventional PE stent with side holes to a PE stent withoutt side holes and did not show a difference in patency rate (14). Our group comparedd a conventional polyethylene stent with side holes to the same design stent madee of Teflon material and also did not show any difference in stent patency (15). Untill now three multicenter randomised trials compared the Teflon Tannenbaum stentt to a polyethylene stent and non of these studies showed any advantage for the Teflonn Tannenbaum stent (8;c))(Table 3).
Abedii and co-workers tested a modified Tannenbaum design stent consisting of a stainlesss steel mesh between an inner Teflon coating and an outer polyamide layer (TTCC stent). Preliminary results from their non-randomised study in 12 patients showedd a mean patency was 134 days and no stent occlusion (n). The authors claim thatt this new stent provides a 20 % greater lumen than a comparable size plastic stent.. Our group however, determined the internal and external diameter of unused biliaryy endoprostheses and could not confirm an increased diameter of the TTC stentt (16). Interestingly, in the study of Abedi, the TTC stent migrated proximally in twoo of twelve patients.
Inn the present randomised study we could not show any difference in patency rate betweenn the TTC stent and the conventional PE stent. In line with the study of Adebi andd co-workers we also observed multiple cases with proximal migration of the TTC stent.. In fact, the difference in the incidence of proximal stent migration between bothh groups (PE o versus TTC 4) was statistically significant.
migra-tion.. In order to improve bile flow these stents were replaced by straight Amsterdam typee stents with one side hole at both ends in which stent migration is prevented by onee side flap, also at both ends. The Tannenbaum stent is designed with four radial sidee flaps that do not penetrate the lumen of the stent. This results in more floppy sidee flaps than is the case with conventional cut side flaps, which, according to our resultss seems unsatisfactory to prevent dislocation. In some centers it is routine practicee to perform a papillotomy to facilitate stent placement and this may even fur-therr contribute to stent migration.
InIn the light of these observations, we performed a crude meta-analysis of all six stud-iess performed with Tannenbaum design Teflon stents and conventional PE stent and foundd a non-significant trend for excess TTC stent migration (p>o.o5) (Table 3). It mustt be noted however, that interpretation of these so-called migrations is difficult becausee in most studies stent migration is not formally defined and it is not noted whetherr stents migrated proximally or distally. To make things even more complicat-ed;; stent migration may remain asymptomatic if the stenosis is still traversed. It may alsoo be wrongly recorded as stent occlusion if the proximal end of the stent gets impactedd in the bile duct wall {proximal migration) or the distal end gets impacted inn the duodenal wall (distal migration). Due to the lack of side holes in the TTC stent thesee conditions mimic stent occlusion but are in fact caused by stent migration. In fact,, the difference between stent dislocation and stent obstruction can only be con-firmedfirmed when the stent lumen is assessed macroscopically or a water immersion test iss performed (17). Unfortunately, in most studies, including our own study, this was nott done.
Inn conclusion, this prospective randomised trial did not confirm the expectations of earlierr studies regarding improved patency rates of Teflon Tannenbaum stents. Thesee stents seem associated with an excess incidence of proximal stent migration, whichh prompts for additional design modifications.
822 E N D O S C O P I C BILIARY DRAINAGE
Tablee l. Patient characteristics.
Noo included Male/Female e Age* * Bilirubinn ** Diagnosis s Pancreatic c Ampullary y cancer r cancer r TTCC stent 30 0 15/15 5 777 (43-93) 2866 (10-837) 30 0 0 0 PEE stent 30 0 14/16 6 788 (61-92) 2244 (64-624) 27 7 3 3
TTC:: Tannenbaum type stent with a thin stainless steel mesh between an inner Teflonn Coating and an outer polyamide layer
PE:: standard Polyethylene stent ** values are median (range) in years *** values are mean (range) in (imol/1
Tablee 2. Results. Complications s Perforation n Haemorrhage e Proximall migration* Stentt dysfunction ERCPP performed noo ERCP performed Patientt survival, days ** Stentt patency, days **
TTCC stent (N= = 0 0 2 2 4 4 18 8 O O 5 5 1 2 1 1 1 0 2 2 =30) ) (9-357)) [52"1 (4--264)) [36-90] ] 168] ] PEE stent (N=3o) ) 1 1 1 1 0 0 1 2 2 1 0 0 2 2 1055 (14-413) [55-155] 1422 (7-277) [32-252] TTC:: Tannenbaum type stent with a thin stainless steel m e s h between an inner
Teflonn Coating and an outer polyamide layer PE:: standard Polyethylene stent
-- p=o.o38
Figuree i . Kaplan-Meier plot of stent patency (p=o.4i). Probabilityy of patency 1,0 0 .bb -.22 . O.O O TTCC Stent PEE Stent 30 0 4 0 0 Timee (weeks)
844 ENDOSCOPIC BILIARY DRAINAGE T3 3 O O ^< < Hi i
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SS o £ ^ too to £ ™^% p p 0 0 0 too to <-> *-" "-1 0 0 o OO 4 * -U HH 4 k 1 WW \ 0 Ï ? s oo dv tf; O O NP P Crr ü£~ < ?^^ # #
0 0 0 o o 0 ^ ^ OQ Q 3 3 o o 3 3 to o to o N? ? ON N CN N G\ G\ 0 0 0 Np p --O --O --O N -2i i > > 3 3 "< < N N ft) ) 0 0 3 3 d5' ' 1-1 1 Cü ü 0 " " 3 3 n n o oREFERENCES S
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