Introduction
Primary sclerosing cholangitis (PSC) is a chronic inflammatory and cholestatic disorder
of the intra- and extra-hepatic bile ducts, closely associated with inflammatory bowel
disease (IBD) [1]
[2]
[3]
[4]. Dominant strictures develop in 45 % to 58 % of PSC patients and it is characterized
by a stenosis ≤ 1.5 mm in the common bile duct or ≤ 1 mm in the hepatic ducts. Treatment
of a dominant stricture with balloon dilation alone or balloon dilation with stent
placement is attempted to provide biliary drainage and to reduce symptoms. In the
presence of a dominant stricture, the suspicion for cholangiocarcinoma (CCA) is high
and the distinction between CCA and benign inflammatory stricture is often difficult.
ERCP with brush cytology and/or biopsy in combination with fluorescence in situ hybridization
(FISH) provides additional diagnostic yield in such cases. Since patients with PSC
undergo repeated ERCP examinations and have stenotic and narrow bile ducts, they may
be at risk for development of ERCP-related adverse events (AEs), in particular bacterial
cholangitis. Rates of post-ERCP AEs vary widely between studies ranging from 2.5 %
to 14 % [5]
[6]
[7]
[8]
[9]. Some studies have shown that ERCP is associated with increased risk of AEs in patients
with PSC when compared to non-PSC patients [6]
[7]
[8]
[9]
[10].
In our earlier study, although the overall risk of post-ERCP AEs was low at 4.3 %,
cholangitis was the most common AE [9]. With the increased frequency of ERCP performed in PSC patients for surveillance,
factors that could potentially reduce the procedure related AEs need to be determined.
We hypothesized that biliary aspiration prior to contrast indication during ERCP may
reduce the pressure in the biliary system and thus decrease the overall AE rate, particularly
the risk of cholangitis in patients with PSC. We also hypothesized that avoiding biliary
stent placement after dilation of dominant bile duct strictures in PSC may lead to
a decrease in cholangitis risk mainly due to elimination of stent dysfunction risk.
Based on these observations, we changed our ERCP approach in which bile aspiration
was performed prior to contrast injection in all patients undergoing ERCP for PSC.
Also, dominant strictures were treated with balloon dilation alone without stent placement.
Our aim was to validate this approach to ERCP interventions in PSC patients with the
objective of decreasing AEs.
Patients and methods
All consecutive patients with PSC who underwent ERCP from 2002 to 2012 at Cleveland
Clinic were retrospectively analyzed using the electronic medical records database.
A total of 156 patients were included in this group. For the purpose of discussion,
we will consider this as group I.
The second group of patients were prospectively recruited from 2012 – 2014, in which
routine bile aspiration (3 – 5 ml of bile) prior to contrast injection during ERCP
was performed. Also, if a dominant stricture was identified, balloon dilation alone
was performed without placement of a biliary stent. This constituted the second group
(46 patients), which for the purpose of discussion, we will consider as group II.
In group II, all patients with inadvertent pancreatic duct cannulations received rectal
indomethacin for prophylaxis against post-ERCP pancreatitis (PEP). If patients received
multiple ERCPs, the first ERCP at our institution was included in our study.
Inclusion and exclusion criteria
All patients with PSC > 18 years of age, who underwent ERCP were included in the study.
Patients who had undergone liver transplantation or hepatico-jejunostomy and those
with active cholangitis prior to the procedure were excluded from the study.
ERCP procedures
In group 1, according to our usual ERCP protocol, wire-guided cannulation of the bile
duct was accomplished using a sphincterotome and guidewire or extraction balloon and
guidewire. Needle knife sphincterotomy was used if access could not be obtained by
standard cannulation equipment. Inadvertent cannulation or injection of the pancreatic
duct was followed by placement of a prophylactic pancreatic stent to reduce the risk
of pancreatitis. Dominant strictures were dilated with a dilating balloon followed
by stenting which was removed after 2 weeks. Patients were sent home with 5 days of
antibiotics following the procedure to prevent cholangitis. All patients received
prophylactic intravenous antibiotics during the procedure. Brush cytology specimens
were collected prior to dilation for cytology and/or FISH if a dominant stricture
was encountered. FISH was only used during the last year of the study period (2012).
Our traditional approach for cannulation in our institution is dye-free guidewire
cannulation. ERCP procedures were performed by experienced interventional endoscopists
using standard endoscopic equipment. All the endoscopists performing ERCP in our study
had performed a minimum of 1000 ERCPs prior to the study and had an annual ERCP volume
of 400 procedures.
In group II, bile aspiration was performed immediately after biliary cannulation and
prior to contrast injection. The other change we instituted was that biliary stents
were not placed after balloon dilation of dominant biliary strictures. The ERCP technique
did not change during the study period. Data were prospectively collected on therapeutic
procedures during ERCP such as sphincterotomy (both biliary and pancreatic), presence
of dominant stricture, stricture dilation, biliary and pancreatic stent placement,
biliary stone extraction.
Our earlier publication discussed the prospectively maintained database of bile obtained
during ERCP [11]
[12]. The database was established in 2012 and includes bile samples linked to demographic,
clinical, and cholangiographic information. The study was approved by the Cleveland
Clinic Institutional Review Board registered with the National Institute of Health
(NIH) clinical trial registry. (NCT01565460).
Adverse events
Post-ERCP AEs were defined based on the ASGE workshop [13]. AEs was recorded up to 30 days following the procedure. PEP was defined as onset
of new abdominal pain and three fold elevation in serum amylase and/or lipase 24 hours
after the procedure up to 2 weeks. Cholangitis was defined as presence of fever, leukocytosis
or positive blood cultures requiring intravenous antibiotics within 14 days after
ERCP. Bleeding was defined as clinical evidence of hemorrhage with a decrease in hemoglobin
greater than 2 g/dL and/or the need for endoscopic or other methods of obtaining hemostasis
within 14 days after ERCP. Perforation was defined as extravasation of contrast or
presence of peritoneal or retroperitoneal free air on imaging after the procedure.
The timing of the AE was recorded.
Outcome measures
The primary outcome measure was to compare rates of AEs and in particular cholangitis
between the groups. Our secondary outcome measure was to investigate the risk factors
predicting the 30-day AEs specifically whether incorporation of a change in our approach
(bile aspiration and balloon dilation without stent placement) impacted the overall
risk of cholangitis and overall AEs.
Statistical analysis
Descriptive statistics were computed for all factors. These include medians, 25th
and 75th percentiles, range or mean and standard deviation for continuous factors
and frequencies and percentages for categorical factors. Baseline patient characteristics,
procedure outcomes, and AEs were calculated for groups I and II.
Logistic regression models were constructed by including variables that had significant
univariable associations with post-ERCP AEs, and then performing backward stepwise
selection with a removal criterion of P > 0.05. R 2.10.1 software (The R Foundation for Statistical Computing, Vienna, Austria)
was used to perform all analyses.
Results
Baseline and procedural characteristics
A total of 202 consecutive patients with PSC underwent ERCP during the study period
from 2002 – 2014. The baseline, procedural characteristics and outcomes of 156 patients
in group I (2002 – 2012) and 46 patients in group II (2012 – 2014) were analyzed.
The demographic, clinical and procedural characteristics between the two groups are
shown in [Table 1]. The mean age of the patients undergoing ERCP in group II was significantly higher
at 54.9 years when compared to 43.7 years in group I (P < 0.001). The other basic demographic characteristics were not significantly different
between the patient groups. Primary cannulation was achieved in 91 % (142/156) and
95.6 % (44/46) in groups I and II respectively. Dye-free guidewire cannulation was
successfully performed in 138/142 (97.2 %) and 43/44 (97.7 %) in groups I and II respectively.
For those who failed primary cannulation, pre-cut sphincterotomy with needle knife
was performed to achieve access. The distribution of PSC was predominantly intrahepatic
in group II and extrahepatic in group I at diagnosis. (P = 0.001). However, most of the procedural characteristics did not significantly differ
between the two groups. There was no difference in the number of patients with native
papillae in group I and group II (26.3 % vs. 34.8 %, P = 0.60) respectively. Biliary sphincterotomy was done in 24.3 % (38 /156) in group
I and 23.9 % (11/46) in group II. Dominant strictures were found in 23 % (36/156)
in group I and 23.9 % (11/46) in group II. Bile duct brushings for cytology was performed
in 52.5 % (82/156) and 45.6 % (21/46) in groups I and II respectively. Biliary stents
were placed in 53.2 % (83/156) in group I and none in group II.
Table 1
Comparison of demographic, clinical and procedure characteristics between the two
groups.
|
Variable
|
Group I (n = 156)
|
Group II (n = 46)
|
P value
|
|
Demographic and patient characteristics
|
|
Gender (%)
|
|
|
0.32
|
|
|
52 (33.3)
|
19 (41.3)
|
|
|
|
104 (66.7)
|
27 (58.7)
|
|
|
Race (%)
|
|
|
0.23
|
|
|
128 (82.1)
|
36 (78.3)
|
|
|
|
15 (9.6)
|
7 (15.2)
|
|
|
|
3 (1.9)
|
1 (2.2)
|
|
|
Age at diagnosis, mean (SD), years
|
40.65 (14.7)
|
44.8 (19.8)
|
0.12
|
|
Age at ERCP, mean (SD), years
|
43.77 (18.9)
|
54.96 (15.8)
|
< 0.001
|
|
BMI, mean (SD)
|
28.13 (12.9)
|
25.48 (5.7)
|
0.18
|
|
Disease Characteristics
|
|
Location of PSC at diagnosis (%)
|
|
|
0.001
|
|
|
37 (23.7)
|
24 (52.2)
|
|
|
|
7 (4.5)
|
3 (6.5)
|
|
|
|
60 (38.5)
|
7 (15.2)
|
|
|
Dominant stricture at diagnosis (%)
|
|
|
0.07
|
|
|
94 (60.3)
|
35 (76.1)
|
|
|
|
36 (23.1)
|
11 (23.9)
|
|
|
Mayo risk score, mean (SD)
|
1.15 (1.5)
|
–0.13 (8.3)
|
0.07
|
|
PSC Severity (%)
|
|
|
0.05
|
|
|
32 (20.5)
|
16 (34.8)
|
|
|
|
81 (51.9)
|
15 (32.6)
|
|
|
|
43 (27.6)
|
15 (32.6)
|
|
|
Bilirubin, mean (SD)
|
3.97 (5.5)
|
1.99 (4.2)
|
0.02
|
|
Procedural characteristics
|
|
Primary cannulation (%)
|
|
|
0.06
|
|
|
142 (91.0)
|
44 (95.7)
|
|
|
|
12 (7.6)
|
2 (4.3)
|
|
|
Precut with needle knife (%)
|
|
|
0.59
|
|
|
143 (91.7)
|
44 (95.7)
|
|
|
|
11 (7.1)
|
2 (4.4)
|
|
|
Biliary sphincterotomy (%)
|
|
|
0.60
|
|
|
75 (48.1)
|
19 (41.3)
|
|
|
|
38 (24.4)
|
11 (23.9)
|
|
|
|
41 (26.3)
|
16 (34.8)
|
|
|
Pancreatic sphincterotomy (%)
|
|
|
0.74
|
|
|
149 (95.5)
|
44 (95.6)
|
|
|
|
4 (2.6)
|
2 (4.4)
|
|
|
|
1 (0.6)
|
0 (0)
|
|
|
Accidental passes into pancreatic duct (%)
|
|
|
0.52
|
|
|
138 (88.5)
|
44 (95.6)
|
|
|
|
15 (9.6)
|
2 (4.4)
|
|
|
Contrast inject into pancreatic duct (%)
|
|
|
0.41
|
|
|
127 (81.4)
|
41 (89.1)
|
|
|
|
27 (17.3)
|
5 (10.9)
|
|
|
Brushings (%)
|
|
|
0.49
|
|
|
72 (46.2)
|
25 (54.3)
|
|
|
|
82 (52.6)
|
21 (45.7)
|
|
|
Biliary stent placement (%)
|
|
|
0.001
|
|
|
73 (46.8)
|
22 (100)
|
|
|
|
83 (53.2)
|
0 (0)
|
|
|
Adverse events (%)
|
0.31
|
|
|
140 (89.7)
|
45 (97.8)
|
|
|
|
5 (3.2)
|
1 (2.2)
|
|
|
|
7 (4.5)
|
0 (0)
|
|
|
|
4 (2.6)
|
0 (0)
|
|
|
Post-ERCP pancreatitis/cholangitis (%)
|
|
|
0.18
|
|
|
144 (92.3)
|
45 (97.8)
|
|
|
|
12 (7.7)
|
1 (2.2)
|
|
SD, standard deviation; BMI, body mass index; IHD, intrahepatic distribution; EHD,
extrahepatic distribution; PEP, post-ERCP pancreatitis
Adverse events
The overall AE rates were 10.3 % (16/156) in group I and 2.1 % (1/46) in group II.
There was no case of cholangitis in group II as opposed to 7 (4.4 %) in group I. There
were 5 (3.2 %) cases of post-ERCP pancreatitis in group I versus 1 (2.1 %) in group
II. All patients with post-ERCP pancreatitis were managed conservatively; none requiring
admission to the intensive care unit. Bleeding was reported in 4 (2.5 %) patients
in group I, compared to none in group II. There were no cases of perforation or procedure-related
mortality.
Among the 46 patients in group II, 22 patients had aspiration and dilation of stricture
without stent placement, while the remaining 24 patients had aspiration alone. Dominant
strictures were seen in 11 patients, while the remaining patients had strictures from
PSC. There were no adverse events in the 22 patients who had aspiration with dilation,
while 1 of the remaining 24 patients developed post-ERCP pancreatitis.
In patients with acute cholangitis, the mean time to occurrence of cholangitis following
ERCP was 5.1 days. The mean length of stay for cholangitis was 7.4 days. Among the
7 patients with cholangitis in group I, 6 patients had biliary stent placement following
dilation of dominant biliary strictures. Among the 6 patients, only 1 patient required
ERCP which was performed 11 days after the initial procedure with stent clogging.
The remaining patients were treated with intravenous antibiotics with clinical improvement.
Among the 6 patients with PEP, the mean time to develop pancreatitis was 1.6 days
following the procedure. The mean length of stay of 6.6 days. Four patients developed
procedure related bleeding; only one of whom required admission to the hospital for
blood transfusion.
Post-ERCP AEs
Univariate analysis
[Table 2] summarizes factors associated with development of any post-ERCP AE. Age and gender
did not influence the rate of AEs in this study. Biliary sphincterotomy, pancreatic
sphincterotomy, accidental wire passage into the pancreatic duct, and biliary stent
placement were associated with increased risk of AEs. Aspiration alone did not impact
the risk of AEs.
Table 2
Univariate Analysis for development of any post-procedure adverse event.
|
Characteristic
|
Adverse event
|
P Value
|
|
No
(n = 185)
|
Yes
(n = 17)
|
|
Gender (%)
|
|
|
0.99
|
|
|
65 (35.1)
|
6 (35.3)
|
|
|
|
120 (64.9)
|
11 (64.7)
|
|
|
Age at diagnosis, mean (SD), yrs
|
41.6 (16.2)
|
41.5 (14.8)
|
0.97
|
|
Age at ERCP, mean (SD), yrs
|
46.2 (19.1)
|
47.5 (15.6)
|
0.78
|
|
BMI, mean (SD)
|
27.7 (12.0)
|
25.9 (6.9)
|
0.54
|
|
Smoker (%)
|
|
|
0.87
|
|
|
143 (77.3)
|
12 (70.6)
|
|
|
|
7 (3.8)
|
1 (5.9)
|
|
|
|
33 (17.8)
|
4 (23.5)
|
|
|
Alcohol (%)
|
|
|
0.89
|
|
|
159 (85.9)
|
15 (88.2)
|
|
|
|
17 (9.2)
|
1 (5.9)
|
|
|
|
5 (2.7)
|
1 (5.9)
|
|
|
Location of PSC at diagnosis (%)
|
|
|
0.51
|
|
|
57 (30.8)
|
4 (23.5)
|
|
|
|
10 (5.4)
|
0 (0)
|
|
|
|
59 (31.9)
|
8 (47.1)
|
|
|
Dominant strictures
|
|
|
0.18
|
|
|
121 (65.4)
|
8 (47.1)
|
|
|
|
40 (21.6)
|
7 (41.2)
|
|
|
PSC severity (%)
|
|
|
0.33
|
|
|
45 (24.3)
|
3 (17.7)
|
|
|
|
85 (45.9)
|
11 (64.7)
|
|
|
|
55 (29.7)
|
3 (17.7)
|
|
|
Mayo risk score, mean (SD)
|
0.9 (4.3)
|
0.9 (1.3)
|
0.92
|
|
Bilirubin, mean (SD), mg/dl
|
3.4 (5.1)
|
5.4 (6.7)
|
0.13
|
|
Precut with needle knife (%)
|
10 (5.4)
|
3 (17.7)
|
0.13
|
|
Biliary sphincterotomy (%)
|
|
|
0.02
|
|
|
40 (21.6)
|
9 (52.9)
|
|
|
|
56 (30.3)
|
1 (5.9)
|
|
|
Pancreatic sphincterotomy (%)
|
3 (1.6)
|
3 (17.7)
|
0.003
|
|
Accidental passes into pancreatic duct (%)
|
13 (7.0)
|
4 (23.5)
|
0.001
|
|
Contrast injection into pancreatic duct (%)
|
|
|
0.07
|
|
|
157 (84.9)
|
11 (64.7)
|
|
|
|
26 (14.1)
|
6 (35.3)
|
|
|
Brushings (%)
|
|
|
0.90
|
|
|
89 (48.1)
|
8 (47.1)
|
|
|
|
94 (50.8)
|
9 (52.9)
|
|
|
Biliary stent placement (%)
|
|
|
0.0001
|
|
|
102 (55.1)
|
17 (100)
|
|
|
|
83 (44.9)
|
0 (0)
|
|
SD, standard deviation; BMI, body mass index; IHD, intrahepatic distribution; EHD,
extrahepatic distribution
Multivariate analysis
On bivariate analysis, a change in ERCP approach was associated with decreased risk
of overall AE (0 % vs. 18.6 %, P = .03). [Table 3] summarizes the factors associated with development of any post-ERCP AE. On multivariate
analysis, biliary stent placement (OR 4.10 (1.32 – 12.71); P = .02) was associated with increased risk of AEs. Bile aspiration prior to contrast
injection did not impact the overall risk. (OR 0.18 (0.02 – 1.43); P = .10).
Table 3
Adjusted odds ratios of each factor on any post-procedure adverse events on multivariate
logistic regression analysis.
|
Variable
|
Odds ratio (95 % CI)
|
P value
|
|
Biliary aspiration
|
0.18 (0.02 – 1.43)
|
0.10
|
|
Presence of dominant stricture
|
0.90 (0.16 – 5.04)
|
0.91
|
|
Biliary stent placement
|
4.10 (1.32 – 12.71)
|
0.02
|
|
PSC Severity
|
|
|
1[*]
|
|
|
|
1.95 (0.48 – 7.82)
|
0.35
|
|
|
1.12 (0.19 – 6.42)
|
0.89
|
PSC, primary sclerosing cholangitis
* Because all patients receiving the treatment approach had no adverse event, its effect
could not be evaluated in multivariate logistic regression.
Cholangitis
On bivariate analysis, a change in ERCP approach was associated with decreased risk
of cholangitis (0 % vs. 10.2 %, P = .02). [Table 4] summarizes factors associated with development of post-ERCP cholangitis. On multivariate
analysis, only biliary stent placement (OR 5.43, 1.38 – 21.38; P = .02) was associated with increased risk of post procedure bacterial cholangitis.
The independent effect of the change in ERCP approach could not be investigated on
multivariate analysis for both cholangitis or other AEs as there were no patients
with cholangitis or other AE.
Table 4
Adjusted odds ratios of each factor on post-procedure cholangitis on multivariate
logistic regression analysis.
|
Variable
|
Odds ratio (95 % CI)
|
P value
|
|
Biliary Aspiration
|
0.22 (0.03 – 1.84)
|
0.16
|
|
Presence of dominant stricture
|
2.32 (0.67 – 8.04)
|
0.18
|
|
Biliary stent placement
|
5.43 (1.38 – 21.38)
|
0.02
|
|
PSC Severity
|
|
|
1[*]
|
|
|
|
1.39 (0.33 – 5.91)
|
0.66
|
|
|
0.84 (0.12 – 5.83)
|
0.86
|
PSC, primary sclerosing cholangitis
* Because all patients receiving the treatment approach had no adverse event, its effect
could not be evaluated in multivariate logistic regression.
Discussion
PSC is a chronic progressive inflammatory disorder of intrahepatic and extrahepatic
bile ducts. The disease course is characterized by the development of clinically significant
biliary strictures, cholangitis, and/or CCA necessitating multiple endoscopic biliary
interventions. Use of endoscopic interventions may improve survival and postpone the
need for liver transplantation [14]
[15]. In this study, we changed the ERCP approach in PSC patients by performing biliary
aspiration prior to contrast injection and avoiding biliary stent placement and studied
its impact on post-ERCP AEs in patients with PSC. We observed that this change in
approach during ERCP in PSC patients was associated with a decreased risk of cholangitis
and overall AEs. Biliary stent placement increased the risk of AEs.
ERCP AEs are associated with significant health care expenditure in the United States
[16]
[17]. Our study was aimed to propose approaches to decrease the overall risk of AEs in
patients with PSC. PSC patients are at increased risk for developing cholangitis,
particularly after ERCP [8]
[9]
[10]. In a study from Mayo clinic, cholangitis was found to occur at a significantly
higher rate in PSC patients undergoing ERCP when compared to non-PSC patients (3.6 %
vs. 0.2 %), with a direct correlation between the length of the procedure and the
rate of cholangitis [8]. Other studies also have demonstrated the increased risk of ERCP AEs in PSC patients,
particularly cholangitis in the context of complex biliary cannulation [6]
[7]
[15]. The anatomy of the bile ducts with multiple strictures and poor biliary drainage,
the duration and complexity of the procedure are the possible factors that additionally
increase the risk of AEs. We hypothesized that biliary aspiration during ERCP would
decrease the pressure within the biliary system and reduce the AE rates, especially
the risk of bacterial cholangitis in PSC patients. Indeed in this study, the group
of patients who underwent bile aspiration prior to contrast injection had lower rates
of AEs. Of particular interest, no episode of post-ERCP cholangitis was observed in
any of these patients while the rate of post-ERCP cholangitis in the traditional group
approached 4.5 %.
Although cholangitis is not as common as pancreatitis following ERCP, the fatality
rate associated with infections is higher than pancreatitis [5]. Dominant strictures in PSC are associated with increased risk of bile stasis, and
warrant repeated endoscopic therapy with endoscopic balloon dilation for improved
outcomes. In the presence of dominant strictures, short term stenting (less than 11
days) and endoscopic balloon dilatation alone without stenting have been found to
be associated with decreased risk of cholangitis [18]
[19]. In our study, we observed that incidence of cholangitis was 4.4 % in group I. Given
the increased risk of cholangitis, we changed our ERCP approach by aspirating bile
and avoiding stent placement. With this approach, none of the patients in group II
had cholangitis. Institution of the new approach with bile aspiration prior to contrast
injection could be the reason for the absence of cholangitis. In fact, recommendations
from the American Association of Liver Disease (AASLD) do not endorse stenting, since
there is no strong evidence demonstrating additional benefit of stenting over endoscopic
dilatation. Stenting should be reserved for strictures that are refractory to dilatation
[20].
PEP is a common AE of ERCP. In the largest series of ERCP in PSC patients from Finland,
the rate of PEP was 9.0 % [7]. In our study PEP rate was 3.2 % and 2.1 % in group 1 and 2 respectively which is
comparatively lower than the other studies. Prophylactic pancreatic stent placement
and rectal nonsteroidal anti-inflammatory drugs were routinely used in patients in
group II and pancreatic stent was routinely used in group I which could explain the
low rates of PEP [21]
[22]. Biliary sphincterotomy, inadvertent pancreatic duct injection or guidewire passage,
prior history of PEP and difficult cannulation has been proposed as risk factors for
PEP [11]
[23]
[24]
[25]
[26]
[27]
[28]
[29]. In our study, biliary or pancreatic sphincterotomy did not significantly increase
the risk of ERCP AEs. Although, these factors were significant on univariate analysis,
the factors became insignificant on multivariate analysis because of low number of
AEs.
There are several limitations to this study including a heterogeneous patient population
undergoing ERCP procedures over a 13-year period. Although statistically not significant,
there was a trend towards a higher Mayo PSC risk score in group 1. Also, there were
more patients with intrahepatic PSC in group II compared to group I. This heterogeneity
could have contributed to the difference in AEs between the 2 groups. Thus, sicker
patients may be at higher risk for post-procedure AEs such as cholangitis. In addition,
the number of AEs was low, limiting the power of the study. This was particularly
the case in group II where there were no cholangitis episodes and only 1 patient had
PEP. The improved operator experience in group II could also explain the decreased
AE. The other question that remains to be evaluated is whether the avoidance of biliary
stents translates to a long-term clinical benefit. We will need long term follow-up
of the patient groups to answer the above question. There is one ongoing randomized
controlled trial to address this question and until then, we do not know the long-term
impact of either technique. (NCT01398917) The strengths of this study are the large
sample size, and the use of electronic medical records across the Cleveland Clinic
Health System which includes multiple hospitals in the community, thus allowing capture
of nearly all AEs even after patient discharge from the main campus hospital and thus
making it possible to report the 30-day AEs in this study with high degree of accuracy.
Conclusions
In summary, changing our approach at ERCP in PSC patients, by aspirating bile prior
to contrast injection and avoiding stent placement after dilatation of dominant strictures
was associated with a decreased risk of post ERCP AEs particularly the risk of bacterial
cholangitis. The role of this approach in reducing the post-ERCP adverse event rates
in patients with PSC needs further assessment in randomized studies.
