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Systematic review

Meta-analysis of randomized clinical trials on safety and


efficacy of biliary drainage before surgery for obstructive
jaundice
Y. Fang1 , K. S. Gurusamy4 , Q. Wang2 , B. R. Davidson4 , H. Lin3 , X. Xie1 and C. Wang1
1
Department of Neurosurgery, 2 Department of Endocrinology and 3 Books and Information Centre, West China Hospital, Sichuan University,
Chengdu, China and 4 Department of Surgery, UCL Medical School, Royal Free Campus London, UK
Correspondence to: Mr K. S. Gurusamy, 9th Floor, University Department of Surgery, Royal Free Hospital, Rowland Hill Street, London NW3 2PF, UK
(e-mail: kurinchi2k@hotmail.com)

Background: This meta-analysis aimed to investigate whether preoperative biliary drainage (PBD) is

beneficial to patients with obstructive jaundice.


Methods: Data from randomized clinical trials related to safety and effectiveness of PBD versus no PBD

were extracted by two independent reviewers. Risk ratios, rate ratios or mean differences were calculated
with 95 per cent confidence intervals (c.i.), based on intention-to-treat analysis, whenever possible.
Results: Six trials (four using percutaneous transhepatic biliary drainage and two using endoscopic
sphincterotomy) including 520 patients with malignant or benign obstructive jaundice comparing PBD
(265 patients) with no PBD (255) were included in this review. All trials had a high risk of bias. There was
no significant difference in mortality (risk ratio 1.12, 95 per cent c.i. 073 to 171; P = 060) between the
two groups. Overall serious morbidity (grade III or IV, ClavienDindo classification) was higher in the
PBD group (599 complications per 1000 patients) than in the direct surgery group (361 complications
per 1000 patients) (rate ratio 166, 95 per cent c.i. 128 to 216; P < 0001). Quality of life was not
reported in any of the trials. There was no significant difference in length of hospital stay between the
two groups: mean difference 487 (95 per cent c.i. 128 to 1102) days (P = 012).
Conclusion: PBD in patients undergoing surgery for obstructive jaundice is associated with similar
mortality but increased serious morbidity compared with no PBD. Therefore, PBD should not be used
routinely.
Paper accepted 8 July 2013
Published online in Wiley Online Library (www.bjs.co.uk). DOI: 10.1002/bjs.9260

Introduction

Periampullary cancer is the term used for cancers that


form near the ampulla of Vater1 , and includes cancer of
the head and neck of the pancreas, cancer of the distal end
of the bile duct, cancer of the ampulla of Vater, and cancer
of the second part of the duodenum. Surgical resection
is generally considered the only curative treatment for
malignant obstructive jaundice due to periampullary
cancer. Approximately 20 per cent of periampullary
cancers presenting to surgeons are resectable2 4 . There
is considerable variation in resectability rates (1495
per cent)5 . The higher resectability rates may reect
referral of patients already considered resectable by the
centre referring the patient.
Obstructive jaundice affects various organs and physiological mechanisms in the body, and can result in kidney
failure6 , cardiac dysfunction6 , liver injury7 , haemostatic
2013 British Journal of Surgery Society Ltd
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abnormalities8 and altered body immunity9 . Restoration of


biliary ow before operation (preoperative biliary drainage;
PBD) can be performed by percutaneous transhepatic biliary drainage (PTBD) under radiological guidance or by
endoscopic sphincterotomy (ES) and stent placement10 .
Patients presenting with cholangitis may require PBD to
improve their condition sufciently to allow surgery. However, many physicians perform PBD routinely in all patients
with malignant obstructive jaundice11 with the intention of
relieving the biliary obstruction and reversing the pathophysiological changes caused by obstructive jaundice.
A previous meta-analysis12 showed that PBD for
malignant obstructive jaundice carries no benet and
should not be performed routinely. In a previous Cochrane
review13 , the present authors concluded that there was
no evidence to support or refute PBD for patients with
obstructive jaundice. However, the previous meta-analysis
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Y. Fang, K. S. Gurusamy, Q. Wang, B. R. Davidson, H. Lin, X. Xie and C. Wang

included older trials, which may no longer be relevant to


modern surgical practice, and did not include a recent trial.
Therefore, the review has been updated in line with the
revision of methods in Cochrane reviews14 , to include this
new trial, reanalysing the data and revising the conclusions.

Two authors independently identied trials for inclusion, and two other authors extracted data related to the
above outcomes and assessed the risk of bias in the trials.
All differences of opinion were resolved by discussion.

Assessment of risk of bias


Methods

The systematic review was conducted following the Preferred Reporting Items for Systematic Reviews and MetaAnalyses (PRISMA)15 and Cochrane Collaboration14
guidelines.

Identification of trials and data extraction


Only randomized clinical trials (irrespective of language,
blinding, sample size, or publication status whether
published as full text or just as conference abstract) that
compared PBD (irrespective of whether it was PTBD or
ES) with no PBD in patients with obstructive jaundice
undergoing major surgical procedures were included in
this review. The cause of jaundice could be either benign
or malignant. Quasi-randomized trials (where the methods
of allocating participants to a treatment are not strictly
random, for example date of birth, hospital record number,
alternation) were not considered for inclusion. There was
no restriction of patients based on the bilirubin level at
randomization. Trials were included for meta-analysis
if they reported at least one of the primary outcomes
(mortality, serious adverse events and quality of life) or
secondary outcomes (hospital stay and costs). Serious
adverse events (morbidity) were dened according to
International Conference on Harmonisation of Technical
Requirements for Registration of Pharmaceuticals for
Human Use Good Clinical Practice (ICH-GCP)
guidelines16 , which correspond roughly to grade III and
IV complications in the ClavienDindo classication17,18 .
Duration of hospital stay was dened as hospital stay related
to the PBD and surgery.
The Cochrane Hepato-Biliary Group (CHBG) Controlled Trials Register19 , the Cochrane Central Register of
Controlled Trials (CENTRAL) in the Cochrane Library
(Wiley), MEDLINE (OvidSP), Embase (OvidSP), Science
Citation Index Expanded (ISI Web of Knowledge) and the
metaRegister of Controlled Trials (mRCT) were searched
until February 2012. The search strategies used were the
same as in the old version of the Cochrane review13 . References of the included trials and the mRCT20 , which
includes International Standard Randomized Controlled
Trial Number (ISRCTN) and National Institutes of
Health (NIH) ClinicalTrials.gov registers, were searched
to identify further trials.
2013 British Journal of Surgery Society Ltd
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As there is a risk of overestimation of benecial treatment


effects in randomized clinical trials with a high risk
of bias21 24 , risk of bias was assessed according to the
guidelines of the Cochrane Collaboration and the CHBG
Module14,19 . The assessment of risk of bias in trials was
based on sequence generation, allocation concealment,
blinding of participants, personnel and outcome assessors,
incomplete outcome data, selective outcome reporting,
and vested interest bias14,19,25 .

Statistical analysis
The software package RevMan 526 , provided by the
Cochrane Collaboration, was used for analysis. For
dichotomous variables, the risk ratio with 95 per cent condence interval (c.i.) was calculated. For count data variables
such as serious adverse events, the rate ratio with 95 per cent
c.i. was determined. For continuous variables, the mean difference with 95 per cent c.i. was calculated. If mean values
were not available for continuous outcomes, medians were
used for meta-analysis. If standard deviations were not
available for continuous outcomes, they were calculated
according to Cochrane Collaboration guidelines14 . This
involves assumptions that both groups have the same variance, which may not be true. In order to assess the impact
of such imputations, a sensitivity analysis was performed by
excluding such trials. Random-effects and xed-effect models were used27,28 . Where there was no difference between
the results of random-effects and xed-effect models that
would change interpretation of the results, the results of
the xed-effect model are reported; otherwise, both results
are reported. Heterogeneity was explored using the 2
test, with signicance set at P = 0100, and the amount of
heterogeneity29 was determined by means of I 2 .
All analyses were based on the intention-to-treat
principle30 , if possible. Otherwise, an available case
analysis14,19 was performed. Planned subgroup analyses
included: trials with low risk of bias versus trials with an
unclear or high risk of bias; PTBD or endoscopic method;
and trials with more than 95 per cent of patients having
malignant jaundice versus those with less than 95 per cent.
The rst subgroup analysis based on the risk of bias was not
carried out because of lack of trials. A sensitivity analysis
was performed by excluding trials in which median or
standard deviation was imputed for continuous outcomes.
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British Journal of Surgery 2013; 100: 15891596

Safety and efficacy of biliary drainage before surgery for obstructive jaundice

Records identified through database searches


n = 4412

1591

Additional record identified through other sources


n=1

Records after duplicates removed


n = 3783

Records screened
n = 3783
Records excluded
n = 3768
Full-text articles assessed for eligibility
n = 15
Full-text article excluded (quasi-randomized study)
n=1
Trials included in qualitative synthesis
n = 6 (14 references)

Trials included in quantitative synthesis


(meta-analysis) n = 6
Fig. 1

PRISMA diagram for the study

Bias exploration using a funnel plot31,32 and Eggers


regression method31 were planned but could not be
performed because of the few trials included in this review.
Results

Search results
A total of 4412 references were identied from medical
journal databases. One new reference was identied by
reference search. No new trials were identied through reference searches or the mRCT. In total, 14 references33 46
for six completed randomized trials fullled the inclusion
criteria (Fig. 1). When citing the references for a trial, both
the main publication and any secondary reports are shown.
A total of 520 patients randomized to PBD (265 patients)
or no PBD (255 patients) were included in the six trials.

Description of included trials


Four trials33,36 39,43 used PTBD as the method of drainage
and two trials34,35,40 42,44 46 used ES. The mean duration
of drainage in four trials33 39 varied between 7 and 18 days.
One trial43 had a mean drainage time of 43 days, and in the
most recent trial40 42,44 46 the duration of drainage was
between 4 and 6 weeks. In one trial40 42,44 46 antibiotic
prophylaxis was not administered routinely for drainage
in patients with distal bile duct obstruction, although
2013 British Journal of Surgery Society Ltd
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perioperative antibiotics were given. Antibiotics were used


routinely for PBD and for surgery in the remaining
trials33 39,43 . Two trials34 38 included only patients with
malignant obstructive jaundice. The proportion of patients
with malignant obstructive jaundice in the other four trials
was 95 per cent33 , 92 per cent40 42,44 46 , 77 per cent39 and
60 per cent43 . One trial40 42,44 46 included patients with
bilirubin levels between 40 and 250 l/l. The remaining
trials33 39,43 included patients with minimum bilirubin
levels ranging from 100 to 172 l/l. One trial39 stated
that only patients in an operable condition were included.
Another trial40 42,44 46 stated that the patients were t for
major surgery. One trial40 42,44 46 stated that patients with
ongoing cholangitis were excluded, but the other trials did
not indicate whether such patients were excluded. Most of
the patients included in the trials were patients with distal
common bile duct obstruction. The risk of bias in the
trials and the reasons for postrandomization drop-out are
summarized in Table 1. All trials were of high risk of bias.

Effect estimates
The effect estimates are summarized in Table 2.

Mortality
There was no signicant difference (risk ratio 112, 95
per cent c.i. 073 to 171; P = 060) in mortality between
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Table 1

Y. Fang, K. S. Gurusamy, Q. Wang, B. R. Davidson, H. Lin, X. Xie and C. Wang

Risk of bias in the six included studies


Random
sequence
generation

Allocation
concealment

Blinding

Incomplete
outcome
data

Hatfield et al.33 (1982)

Lai et al.34,35 (1994)


McPherson et al.36 38 (1984)

?
?

?
?

Pitt et al.39 (1985)


van der Gaag et al.4042,4446 (2010)

+
+

?
+

Wig et al.43 (1999)

Reference

Postrandomization dropouts
(no. and reasons)

Selective
reporting

Vested
interest
bias*

?
?

10 (18%): hepatocellular carcinoma


(1); cross-over (1); technical failure
(3); operation unjustified (1);
preoperative deaths (4) (included
for the outcome mortality)
0 (0%)
5 (7%): benign disease (4);
metastatic deposit (1)
4 (5%): reasons not stated
6 (30%): did not meet inclusion
criteria (4); withdrew consent
before group allocation (2)
Not stated

+, Low risk of bias; , high risk of bias; ?, unclear risk of bias. *Present when a trial is conducted or funded by a party that stands to gain or lose
depending on the results of the trial.
Table 2

Effect estimates for preoperative biliary drainage versus direct surgery in patients with obstructive jaundice
Illustrative comparative risks*

Outcome
Mortality
Long-term survival
(follow-up 24 months)
Serious adverse events
Hospital stay (days)

Assumed risk
in control
groups

Corresponding risk for


PBD groups

Relative effect

No. of patients

Quality of
evidence
(GRADE)

133 per 1000


756 per 1000

149 (97, 228) per 1000


719 (600, 826) per 1000

Risk ratio 112 (073, 171)


Hazard ratio 090 (065, 124)

520 (6 studies)
185 (1 study)

Very low
Very low

361 per 1000


Mean 1662

599 (462, 780) per 1000


487 higher (128 lower, 1102 higher)

Rate ratio 166 (128, 216)

503 (6 studies)
271 (2 studies)

Very low#
Very low# **

Values in parentheses are 95 per cent condence intervals (c.i.) unless indicated otherwise. *The basis for the assumed risk is the mean control group risk
across studies; the corresponding risk (and its 95 per cent c.i.) is based on the assumed risk in the comparison group and the relative effect of the
intervention (and its 95 per cent c.i.). Grading of Recommendations Assessment, Development and Evaluation (GRADE) Working Group grades of
evidence: high quality further research is very unlikely to change our condence in the estimate of effect; moderate quality further research is likely to
have an important impact on our condence in the estimate of effect and may change the estimate; low quality further research is very likely to have an
important impact on our condence in the estimate of effect and is likely to change the estimate; very low quality we are very uncertain about the
estimate. All trial(s) had a high risk of bias. Overlaps 1 and 075 or 125. There were few trials to assess publication bias. #I 2 value greater than 40 per
cent; there was also minimal overlap of condence intervals between some of the trials. **Overlaps 0 and minimal clinically important difference.

the two groups (Fig. 2). The mortality rate was 149
per cent (adjusted proportion calculated by multiplying the
risk ratio by the control group proportion; crude rate 40 of
265, 151 per cent) in the PBD group and 133 per cent (34
of 255) in the direct surgery (no PBD) group. There was
no change in the results when a random-effects model was
used. Heterogeneity was not statistically signicant (I 2 = 0
per cent; P = 070). Tests for subgroup differences were not
statistically signicant for the subgroup analyses. Exclusion
of the trial by van der Gaag and colleagues40 42,44 46 , which
measured mortality for up to 120 days (whereas the other
trials measured 30-day or in-hospital mortality), did not
affect the results. The only trial40 42,44 46 that reported
on long-term survival in patients who had successful
pancreatoduodenectomy for cancer found no signicant
difference between the two groups (hazard ratio 090, 95
per cent c.i. 065 to 124).
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Overall morbidity serious adverse events


Morbidity was signicantly higher in the PBD group
than in the control group (rate ratio 166, 95
per cent c.i. 128 to 216; P < 0001) (Fig. 3). There
was no change in results when a random-effects model
was used. Heterogeneity was not statistically signicant
(I 2 = 44 per cent, P = 011). Subgroup differences were
not statistically signicant for the subgroup analysis. A
post hoc sensitivity analysis was performed by excluding
the trials of Lai and colleagues34,35 (severity of complications could not be assessed), Pitt and co-workers39 (this
trial included a signicant proportion of proximal obstructions) and van der Gaag et al.40 42,44 46 (routine antibiotic
prophylaxis was not used for distal obstructions). There
was no change in the results with any of these sensitivity
analyses.
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Safety and efficacy of biliary drainage before surgery for obstructive jaundice

1593

Mortality rate
Reference

PBD
33

Hatfield et al.
Lai et al.34,35
McPherson et al.3638
Pitt et al.39
van der Gaag et al.4042,4446
Wig et al.43

4 of 29
6 of 43
11 of 34
3 of 37
15 of 102
1 of 20

Total

40 of 265

Direct surgery Weight (%)


4 of 28
6 of 44
6 of 31
2 of 38
12 of 94
4 of 20
34 of 255

Risk ratio

Risk ratio

117
171
181
57
360
115

097 (027, 349)


102 (036, 293)
167 (070, 398)
154 (027, 870)
115 (057, 233)
025 (003, 205)

1000

112 (073, 171)

Heterogeneity: 2 = 299, 5 d.f., P = 070; I 2 = 0%


Test for overall effect: Z = 053, P = 060

001

01

Favours PBD

10

100

Favours direct surgery

Forest plot comparing mortality in trials that used preoperative biliary drainage (PBD) before surgery and those that did not
(direct surgery). A MantelHaenszel xed-effect model was used for meta-analysis. Risk ratios are shown with 95 per cent condence
intervals

Fig. 2

Weight (%)

log [rate ratio]

s.e.

Hatfield et al.33

192

062

47

682 (202, 2299)

Lai et al.34,35

039

033

165

148 (077, 282)

McPherson et al.3638

076

047

81

214 (085, 537)

Pitt et al.39
van der Gaag et al.4042,4446

003
062

039
020

118
450

103 (048, 221)


186 (126, 275)

Wig et al.43

006

036

139

106 (052, 215)

1000

166 (128, 216)

Reference

Total

Rate ratio

Heterogeneity: 2 = 897, 5 d.f., P = 011; I2 = 44%


Test for overall effect: Z = 378, P < 0001

Rate ratio

005

02

Favours PBD

20

Favours direct surgery

Forest plot comparing serious adverse events in trials that used preoperative biliary drainage (PBD) before surgery and those that
did not (direct surgery). Data are shown in a logarithmic scale. An inverse-variance xed-effect model was used for meta-analysis. Rate
ratios are shown with 95 per cent condence intervals

Fig. 3

Quality of life

Costs

None of the trials reported on quality of life.

None of the trials reported this outcome.

Hospital stay
Meta-analysis of two trials39 42,44 46 showed a signicantly
longer hospital stay in the PBD group in the xed-effect
model (mean difference 426 (95 per cent c.i. 092 to
761) days; P = 001) but not in the random-effects model
(mean difference 487 (128 to 1102) days; P = 012).
Heterogeneity was statistically signicant (I 2 = 68 per cent,
P = 008). No subgroup analysis was performed because
there were only two trials for this outcome. Sensitivity
analysis, excluding the trial of van der Gaag et al.40 42,44 46
in which the mean and standard deviation were imputed
from median and interquartile range values, resulted in
the inclusion of only one trial39 . This trial39 showed a
signicantly longer hospital stay in the PBD group.
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Discussion

This review shows that the combination of PBD and


surgery increased the rate of serious adverse events
compared with that for direct surgery without PBD, and
had no signicant advantages. Overall mortality in patients
with obstructive jaundice undergoing surgery following
PBD was no different from that with no PBD. One of the
factors explored was whether this represents the current
situation, as many of the trials were old. The mortality rate
was therefore calculated excluding the trial by van der Gaag
and colleagues40 42,44 46 from 2010, which contributed
nearly 40 per cent of patients in the review. There was no
change in the results. The main question is whether this is
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Y. Fang, K. S. Gurusamy, Q. Wang, B. R. Davidson, H. Lin, X. Xie and C. Wang

lack of evidence of effect or evidence of lack of effect. There


is currently no accurate way of determining this. The
denition of imprecision of results used by the Grading of
Recommendations Assessment, Development and Evaluation (GRADE) handbook for grading quality of evidence
and strength of recommendations was therefore utilized,
as recommended by the Cochrane Collaboration47,48 . The
total number of events in this review was less than 300
and condence intervals of mortality overlap no effect
and appreciable benet or appreciable harm. Thus, a
difference in mortality between the two groups cannot be
ruled out. The only trial40 42,44 46 reporting on long-term
survival showed no difference between the groups. Again,
condence intervals were wide, so a difference in long-term
survival between the two groups cannot be ruled out.
Overall serious morbidity was higher in the PBD group
than in the control group. This difference was unaffected
by different statistical methods and various sensitivity
analyses. There was heterogeneity in this outcome, mainly
because of the magnitude of the effect rather than the
direction of the effect the serious adverse event rate
was higher in the PBD group but there is uncertainty
regarding the actual value. The denitions used for serious
adverse events were those used by regulatory authorities,
such as the Food and Drug Administration, the Medicines
and Healthcare Products Regulatory Agency and the
Japan Society of Quality Assurance in the USA, Europe
and Japan respectively16 , for adverse events related to a
pharmacological intervention. Serious adverse effects of
this ICH-GCP classication correspond roughly to grade
III or IV events in the ClavienDindo classication17,18 .
Inevitably, some information will be lost by using such
classications, which pool complications together.
None of the trials reported on quality of life.
Theoretically, decompression of the biliary obstruction
may improve quality of life by reducing symptoms of biliary
obstruction such as itching, but it may produce anxiety by
delaying surgery and as a result of complications related
to the PBD procedure. From the patients perspective,
long-term survival and quality of life are the important
determinants that should guide the healthcare provider
regarding use of the procedure. However, in the absence
of differences in long-term outcome, short-term outcomes
such as morbidity and hospital stay remain important. From
a healthcare funding perspective, cost per quality-adjusted
life-year, which takes into account long-term survival and
quality of life together with short-term outcomes such as
morbidity (and the cost for management of the morbidity),
and hospital stay are important determinants with respect
to funding or not funding the treatment. As morbidity
was higher in the PBD group and may be associated

with reduced quality of life and substantial costs for the


treatment of these complications, funding for routine PBD
may be inappropriate.
An important question to be answered is whether PBD
was performed appropriately in the trials. The criteria
used to assess the success and the duration of PBD
varied between studies. A short drainage time may not be
sufcient to demonstrate benet, but long drainage may
increase the risk of PBD-related complications and allow
cancer progression. There is little information available
on the optimal duration of drainage, and also considerable
controversy regarding the method of drainage and the
type of stent used49,50 .
All of the trials had a high risk of bias. Allocation was
unclear in most of the trials. Blinding of outcome assessors
was not performed in most trials, and most of the trials
had postrandomization drop-outs. From the information
available regarding postrandomization drop-outs, there
was no specic pattern in the reasons for drop-out.
Considering that the PBD intervention was carried out
before surgery, and that surgery was not performed in
patients who did not meet the inclusion criteria or who
refused the surgery, it appears that postrandomization
drop-outs are inevitable. Although an available case analysis
may be appropriate when the drop-outs are not related to
the intervention25 , strict intention-to-treat analysis has
to be followed in this situation because some patients
could become unresectable during PBD (while awaiting
denitive surgery). Overall, the risk of bias was high and
the true effect may be different from that obtained in this
meta-analysis. The effect of PBD on mortality appeared
to be consistent, whereas the magnitude of its effect on
serious adverse events was not consistent across trials.
However, as far as directness of evidence is concerned,
surrogate outcomes were not used and so there is no
concern regarding the directness of short-term mortality
and morbidity. Although there was no information on
long-term survival and quality of life, it is likely that PBD
has only a short-term effect (benecial or harmful).
As there were no language, publication status or sample
size restrictions14 , any bias due to trial selection was
minimized in this study. It was not possible to assess
reporting bias because of the small number of trials. PBD
has now been available for several years, including the
premandatory trial registration era. Thus, there may be
unreported or unidentied trials. Of the six trials identied,
one40 42,44 46 included patients with bilirubin levels
between 40 and 250 l/l. In the remaining trials33 39,43
minimum bilirubin levels ranged from 100 to 172 l/l.
Thus, the results of this review are applicable to patients
with either mild or severe obstructive jaundice, although

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British Journal of Surgery 2013; 100: 15891596

Safety and efficacy of biliary drainage before surgery for obstructive jaundice

not to patients with cholangitis or those undergoing


neoadjuvant chemotherapy, who may need drainage while
having chemotherapy.
Based on the above discussion, it appears that there
is no strong evidence to recommend PBD or to refute
its value. PBD may increase the rate of serious adverse
events. It is also an additional intervention associated with
complications that result in further costs to healthcare
funders. Routine use of PBD in patients with obstructive
jaundice who are about to undergo surgery cannot be
recommended outside randomized clinical trials.
Acknowledgements

This paper is based on a Cochrane review most


recently substantively amended in the Cochrane Library
2012, Issue 9 (see http://www.thecochranelibrary.com/
for information). Cochrane reviews are updated regularly
as new evidence emerges and in response to feedback,
and the Cochrane Library should be consulted for
the most recent version of the review. The Cochrane
Collaboration disclaimer states: The results of a Cochrane
review can be interpreted differently, depending on
peoples perspectives and circumstances. Please consider
the conclusions presented carefully. They are the opinions
of review authors, and are not necessarily shared by the
Cochrane Collaboration.
This work was funded by the UK National Institute
for Health Research (NIHR). The views and opinions
expressed are those of the authors and do not necessarily
reect the views of the NIHR, National Health Service or
Department of Health.
Disclosure: The authors declare no conict of interest.
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