Outcome of Endoscopic Minor Papillotomy

 

Department of Medicine, Division of Gastroenterology, Duke University Medical Center. Durham,
North Carolina, USA.
2
Lahey Clinic, Burlington, Massachusetts, USA
ABSTRACT
Context Pancreas divisum has been
associated with recurrent acute pancreatitis,
chronic abdominal pain without elevated
pancreatic enzymes, and chronic pancreatitis.
Prior studies suggest that endoscopic minor
papillotomy benefits certain symptomatic
pancreas divisum patients. However, the data
are quite limited and there is a lack of long-
term follow-up.
Objective To describe a retrospective study
of endoscopic minor papillotomy for pancreas
divisum.
Patients Eighty-nine adult patients who
underwent endoscopic minor papillotomy at
our referral center were included in the study.
Median follow-up was 29 months.
Intervention We conducted a telephone
survey. Fifty-three patients were available for
the telephone survey.
Results Thirty-two patients (60.4%) reported
immediate improvement: however, symptoms
recurred in 17 (53.1% of the immediate
responders). Repeat endoscopic interventions
were performed in 8 patients, with long-term
improvement in two. Overall long-term
improvement was achieved in 17 patients
(32.1%). Results of minor papillotomy were
more favorable for patients with recurrent,
well-defined bouts of pancreatitis (immediate
improvement:
P=0.036;
long-term
improvement: P=0.064) compared to those
with pancreatitis who reported continuous
pain and those without clinical evidence of
pancreatitis (immediate improvement: 73.3%,
42.9% and 44.4%, respectively; long-term
improvement: 43.3%, 21.4%, and 11.1%,
respectively).
Conclusions The long-term benefit from
endoscopic minor papillotomy using strict
criteria is poorer than suggested from
previous studies. However, pancreas divisum
patients with well-defined bouts of
pancreatitis are more likely to benefit from
endoscopic minor papillotomy than those
without symptom-free intervals between
"attacks" and those with pain that is not
associated with elevated pancreatic enzymes.
INTRODUCTION
A minority of patients with pancreas divisum
becomes symptomatic with recurrent acute
pancreatitis [1, 2, 3, 4, 5, 6, 7], chronic
pancreatitis [8, 9, 10], or chronic abdominal
pain without evidence of pancreatitis [11].
The underlying mechanism in these cases is
thought to be a relative outflow obstruction at
the site of the minor papilla due to a true or

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relative stenosis. The finding of chronic
obstructive changes confined to the dorsal
pancreatic duct supports this hypothesis [8,
12, 13, 14]. Surgical sphincteroplasty [15, 16,
17] as well as endoscopic interventions such
as endoscopic minor papillotomy (EMP) [18,
19, 20, 21, 22], insertion of dorsal duct stents
[23, 24, 25], dilation [26, 27] and injection of
botulinum toxin into the minor papilla [28]
have been applied with variable success in
symptomatic patients. Currently it is difficult
to reliably select patients who will benefit
from endoscopic therapy, and data about
long-time results after EMP are lacking. We
wish to report our personal experience of a
large series of EMP for pancreas divisum.
MATERIAL AND METHODS
Patients
The endoscopic database of the Duke
University Medical Center was searched for
patients who underwent EMP for
symptomatic pancreas divisum between June,
1993, and March, 2001. EMP was performed
with either a needle knife over a previously
placed dorsal pancreatic duct stent (as
described elsewhere [29, 30]) or with a
conventional
Erlangen-type
(“pull”)
sphincterotome and subsequent placement of
3 or 5 French stents into the minor pancreatic
duct to protect against early scarring and
obstruction by edema. Pure cutting current
was used. Stents were typically removed
within 2-4 weeks to avoid stent-induced
damage to the pancreatic duct. Patients with
pancreatic resection prior to or within 2 weeks
after EMP (n=2) and those who were less than
18 years at the time of follow-up (n=1) were
excluded. Eighty-nine patients were included
in the study. The median age at the time of
EMP was 49 years (range: 17-78 years); 31
patients (34.8%) were male and 58 (65.2%)
were female.
The ERCP reports of the 89 patients included
in the study were retrospectively reviewed.
Irregularities or dilatations of the pancreatic
ductal system were reported in 61 patients
(68.5%).
Follow-up Study
For patients who met the study inclusion
criteria, a registered nurse or physician
conducted a telephone interview using a
questionnaire. Thirty-three patients had
moved, leaving no forwarding addresses or
telephone number, two patients refused to
participate and one patient was not competent
to answer the questionnaire and was therefore
excluded. Thus, 53 patients (59.6%) were
available for follow-up. The median age at the
time of EMP was 50 years (range: 17-78
years; P=0.377 vs. the 36 excluded patients);
19 patients (35.8%) were male and 34
(64.2%) were female (P=0.825 vs. the 36
excluded patients). Median follow-up was 29
months (range: 13-91 months).
Symptoms
Symptoms before and after EMP were
recorded at the telephone interview. Patients
were grouped into those with recurrent acute
pancreatitis (n=30; 56.6%), those with
pancreatitis and continuous pain or
incomplete relief between bouts (n=14;
26.4%) and those with chronic abdominal
pain but no evidence of pancreatitis (n=9;
17.0%). Relief of symptoms after EMP was
considered “immediate improvement”.
Patients with no symptoms or minimal
symptoms (less or equal to 2 on a VAS scale
from 0 to 10) after EMP and no recurrence of
symptoms were considered as having “long-
term improvement”. Those who had recurrent
symptoms which resolved with repeat EMP
were also considered as having “long-term
improvement”.
STATISTICS
Contingency tables were analyzed by means
of the Fisher's exact test (2x2 tables) or the
hierarchical log-linear models. Age was
analyzed by means of the Student's t-test.
Two-tailed P values less than 0.05 were
considered statistically significant. Statistical
analysis was performed by running the SPSS
8.0 for Windows.

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ETHICS
The study was approved by the Duke
University Medical Center Institutional
Review Board.
RESULTS
Complications
Post-ERCP pancreatitis occurred in 10 of the
89 patients included in the study (11.2%). The
pancreatitis was “mild” in 6 and “moderate”
in 4 patients, according to a commonly used
grading system [31]. In one of those patients,
the pancreatitis was felt to be due to
pancreatic stent occlusion one week after
minor papillotomy. In another, it was related
to proximal stent migration. A 54 year old
female patient died during follow up. She
underwent EMP for pancreatitis and
continuous abdominal pain (RP+CAP).
Repeat ERCP with pancreatic duct stenting
resulted in transient improvements of her
symptoms.
She
finally
underwent
pancreaticoduodenectomy
(Whipple
procedure) for chronic pancreatitis. The
operation was complicated by small bowel
necrosis and sepsis, which led to multiple re-
operations and long term hospitalization. The
patient died 3 years after the initial EMP and
one year after surgery.
A stricture developed in the pancreatic neck
of a 45 year old woman in whom a 5 French,
5 cm pancreatic stent was left in place for 6
weeks after EMP. She became free of
symptoms after stent removal and endoscopic
stricture dilation.
Stenting of the Dorsal Pancreatic Duct
prior to EMP
Six patients had trials of dorsal duct stents
prior to EMP: two developed pancreatic duct
strictures which were thought likely to be
stent induced. The first patient was a 40 year
old woman with a history of pancreatitis and
chronic abdominal pain (RP+CAP). She
responded well to a one month trial of a 5
French, 3 cm stent and subsequent EMP. Her
symptoms recurred after 6 months. At that
time, a mild-to-moderate stricture in the
pancreatic head was demonstrated by ERCP.
Endoscopic stricture dilation resulted in
transient improvement of her symptoms only.
The
patient
underwent
surgical
sphincteroplasty without lasting benefit.
Finally, a lateral pancreaticojejunostomy
(Puestow procedure) was performed. She
continued to have pain requiring narcotic
analgesia.
The second patient was a 60 year old man
with recurrent bouts of pancreatitis and
radiographic findings consistent with chronic
pancreatitis. He underwent repeated stenting
of the dorsal pancreatic duct with 5 French, 3
cm stents over a three year period. During that
time, a stricture developed in the head of the
pancreas, with “upstream” ductal dilatation. It
was not clear if the stricture was the result of
chronic pancreatitis or induced by pancreatic
duct stenting. The patient responded well to
EMP, endoscopic stricture dilation and short
term stenting, but his symptoms recurred after
8 months. 6 years after the initial EMP, he
finally underwent a Puestow-procedure with a
favorable response.
Figure 1.
Outcome after endoscopic minor
papillotomy.
Patients included
89
No long-term improvement
36/53 (67.9%)
Long-term improvement
17/53 (32.1%)
Pancreatic surgery
9 (25.0%)
Refused to participate
2
Lost to follow-up
33
Available for phone survey
53 (59.6%)
No improvement
21 (39.6%)
Immediate improvement
32 (60.4%)
Recurrence
17 (53.1%)
No recurrence
15 (46.9%)
Repeat
Endoscopic intervention
8 (47.1%)
No repeat
endoscopic intervention
9 (52.9%)
6 (75.0%)
2 (25.0%)
Incompetent
1

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Response to EMP
The outcome after EMP is summarized in
Figure 1. Thirty-two out of 53 patients
(60.4%) had immediate improvement after
minor papillotomy; 21 patients did not. Of the
32 patients with immediate response, pain
recurred in 17 (53.1% of the immediate
responders) after a median of 6 months
(range: 1-24 months). Of the 17 patients with
recurrent symptoms, repeat endoscopic
interventions were performed in 8 (EMP in 7
patients, pancreatic stent removal and dilation
of a stent induced stricture in 1 patient), with
long-term improvement in 2 patients.
Summarizing these data: 17 (32.1%) patients
had long term improvement (15 had no
recurrence and 2 required a second
endoscopic intervention) and 36 (67.9%)
patients had no long-term improvement (21
had no initial improvement, 15 had
recurrence).
Nine patients underwent pancreatic surgery
during follow-up: one underwent both major
and minor surgical sphincteroplasty, one had
a pancreatic tail resection; a cystojejunostomy
was performed in 2 and a
pancreaticojejunostomy in 5 patients, one of
whom had recurrent symptoms after
sphincteroplasty of the minor papilla; in 3 of
these patients, pancreaticojejunostomy was
combined with a partial pancreatic resection.
The response to EMP for the different groups
are summarized in Table 1Patients with well
defined bouts of pancreatitis (RP) had
significantly (P=0.036) better immediate
improvement than those with pancreatitis who
reported continuous pain or incomplete relief
between bouts (RP+CAP) and those with
chronic abdominal pain without clinical
evidence of pancreatitis (CAP) (immediate
improvement: 73.3%, 42.9% and 44.4%,
respectively; long-term-improvement: 43.3%,
21.4% and 11.1%, respectively).
Thirty-six (67.9%) of the follow-up patients
had irregularities within the dorsal ductal
system while 17 (32.1%) had normal dorsal
ducts. There was a non-significant trend
towards better outcome for patients with
regular and nondilated dorsal pancreatic ducts
vs. irregular/dilated dorsal duct (immediate
improvement: 76.5% vs. 52.8%, P=0.137;
long-term-improvement: 41.2% versus
27.8%, P=0.360; Table 2). Differences in the
clinical presentation prior to EMP were small
between these groups: RP 11/17 (64.7%) vs.
19/36 (52.8%), P=0.529; RP+CAP 2/17
(11.8%) vs. 12/36 (33.3%), P=0.113; CAP
4/17 (23.5%) vs. 5/36 (13.9%), P=0.245;
regular dorsal duct vs. irregular/dilated dorsal
duct, respectively.
Table 2. Outcome of endoscopic minor papillotomy in respect to pancreatic dorsal duct findings.
Irregular/dilated dorsal duct
(n=36)
Regular dorsal duct
(n=17)
P value
Immediate improvement
19 (52.8%)
13 (76.5%)
0.137
Long-term improvement
10 (27.8%)
7 (41.2%)
0.360
Table 1. Treatment response to endoscopic minor papillotomy.
RP
(n=30)
RP+CAP
(n=14)
CAP
(n=9)
Immediate improvement
22 (73.3%)
P=0.036
6 (42.9%)
P=0.308
4 (44.4%)
P=0.440
Long-term improvement
13 (43.3%)
P=0.064
3 (21.4%)
P=0.804
1 (11.1%)
P=0.290
RP: recurrent acute pancreatitis
RP+CAP: pancreatitis with continuous pain or incomplete relief between bout
CAP: chronic abdominal pain without associated pancreatic enzyme elevations

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DISCUSSION
The prevalence of pancreas divisum in
patients who undergo ERCP is about 4-8% in
Western populations and less than 2% in
Asians [2, 6, 8, 14, 32, 33, 34, 35, 36]. In
most patients, pancreas divisum is an
incidental finding; only a small subset of
these patients develops symptoms. It has been
postulated that minor papilla stenosis is a
necessary predisposing factor in the evolution
of symptomatic disease [4, 11, 16].
Therapeutic interventions aim to relieve the
obstruction by improving pancreatic drainage
via the minor papilla. Surgical
sphincteroplasty has been shown to be
effective [4, 5, 7, 15, 16, 17, 37, 38, 39, 40,
41]. Endoscopic interventions such as minor
papillotomy or dilation and subsequent dorsal
duct stent placement provide less invasive
alternatives. EMP was first described in 1978
[42]. This has been followed by several series
of endoscopic interventions such as EMP,
dorsal pancreatic duct stenting or dilation,
with results comparable to surgical
sphincteroplasty. The only randomized
controlled trial of endoscopic therapy for
pancreas divisum was reported by Lans et al.
[23]: 19 patients with pancreas divisum and
recurrent acute pancreatitis were randomized
to dorsal duct stent placement or no treatment.
Symptomatic improvement was observed in
90% of patients in the stent-group versus 11%
of the controls. The study shows a statistically
significant benefit of dorsal duct stenting but
is clearly limited by the very small number of
patients included.
In the present study, 60% of patients reported
improvement after EMP; however, symptoms
recurred in about one half of these cases. It is
doubtful that patients with transient
improvement are true responders to EMP.
Since there were no controls with sham
procedure, a placebo effect cannot be ruled
out in these patients. Furthermore, in patients
with acute recurrent pancreatitis, it is
impossible to reliably define short term
improvement. These patients might have
experienced a symptom-free interval anyway,
regardless of the endoscopic intervention.
However, 8 out of 16 patients with recurrent
symptoms had sustained improvement for 6
months or longer. It is natural to suspect
restenosis of the papillotomy site in these
patients; restenosis is common both after
surgical sphincteroplasty and EMP. In a series
by Warshaw et al. [16], restenosis occurred in
7 out of 88 patients (8%) after surgical
sphincteroplasty. In these patients, repeat
sphincteroplasty can be technically difficult.
The frequency of restenosis after EMP was
estimated at 19% by Lehman et al. [19], and
at 11.5% by Kozarek et al. [20]. In the present
study, repeat endoscopic interventions for
recurrent symptoms were performed in 8
patients, with favorable long-term response in
only two. Three of the 6 patients who failed to
improve after repeat endoscopic treatment
improved after surgery (data not shown):
sphincteroplasty of the major and minor
papilla in one and lateral pancreat-
ojejunostomy (Puestow) in 2, one of which
was preceded by sphincteroplasty of the
minor papilla with recurrence of symptoms.
We conclude that an attempt at repeat
endoscopic therapy is justified in patients
with recurrent symptoms. However, patients
with ongoing of symptoms often require
surgical sphincteroplasty or a surgical
drainage procedure. Given that the results of
surgical sphincteroplasty are no better than
for endoscopic papillotomy, surgeons are
increasingly recommending pancreato-
jejunostomy for patients who fail endoscopic
therapy if the dorsal pancreatic duct is dilated.
In the present series, which, to the best of out
knowledge, is the largest in the literature,
long-term response to EMP using strict
criteria was only 33%. Previous data suggest
a much less favorable outcome for patients
with chronic pancreatitis or pain alone than
for those with acute recurrent pancreatitis [2,
7, 11, 19, 20, 43, 44]. Our data are in
agreement with this. We grouped the patients
according to their clinical presentation.
Patients with well defined bouts of recurrent
acute pancreatitis had significantly higher
response rates to EMP than those with
pancreatitis and continuous pain, and those
with pain alone. However, even for the

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patients with recurrent acute pancreatitis the
results were sobering, less than half were free
of symptoms at follow up. This is a poorer
result than previously reported (Table 3). This
might be explained partially by chronic
pancreatic damage that is not reversible by
EMP. Sixty-nine percent of the patients
included in the present study had radiographic
changes in the dorsal pancreatic ductal
system, such as strictures or dilatation. Other
authors report radiographic evidence of ductal
changes consistent with chronic disease in 30-
57% of patients with pancreas divisum [8, 14,
27]. In symptomatic patients, the chronic
component likely limits the success of
endoscopic or surgical interventions at the
minor papilla.
The present study suggests that EMP has an
acceptable complication rate: mild or
moderate post-procedure pancreatitis was
Table 3. Review of published data on improvement after endoscopic therapy for pancreas divisum as defined by
resolution of pain or recurrent pancreatitis.
Author
Intervention*
Follow up
(months)
All
Recurrent
pancreatitis
Chronic
pancreatitis
Pain alone
McCarthy 1988 [25]
Stent
Mean: 14
17/19
(89.5%)
NA
NA
NA
Lans 1992 [23]
Stent
Mean: 29
9/10
(90.0%)
9/10
(90.0%)
NA
NA
Barkun 1990 [50]
(abstract)
Dil. +/- Stent
Median: 36
9/20
(45.0%)
NA
NA
NA
Ertan 2000 [24]
Stent
Mean: 24
19/25
(76.0%)
19/25
(76.0%)
NA
NA
Siegel 1990 [21]
EMP + Stent
Mean: 24
26/31
(83.9%)
26/31
(83.9%)
NA
NA
Heyries 2002 [18]
EMP +/- Stent
Median: 39
22/24
(91.7%)
22/24
(91.7%)
NA
NA
Lehman 1993 [19]
EMP
Mean: 20
22/51
(43.1%)
13/17
(76.5%)
3/11
(27.3%)
6/23
(26.1%)
Coleman 1994 [43]
Stent +/- EMP
Mean: 23
21/34
(61.8%)
7/9
(77.8%)
12/20
(60.0%)
2/5
(40.0%)
Liguory 1986 [22]
EMP
Range: 12-30
5/8
(62.5%)
5/8
(62.5%)
NA
NA
Kozarek 1995 [20]
EMP/Stent/EMP+Stent Mean: 26
18/39
(46.2%)
11/15
(73.3%)
6/19
(31.6%)
1/5
(20.0%)
Soehendra 1986 [58]
EMP
Range: 1-8
5/6
(83.3%)
2/2
(100%)
3/4
(75.0%)
NA
Rutkovsky 1992 [49]
(abstract)
EMP
Mean: 21
8/19
(42.1%)
NA
NA
NA
Russell 1984 [39]
EMP
NA
1/5
(20.0%)
NA
NA
NA
Satterfield 1988 [27]
Dil./Stent
Mean: 18
6/10
(60.0%)
6/6
(100%)
0/4
(0%)
NA
Overall
188/301
(62.5%)
120/147
(81.6%)
24/58
(41.4%)
9/33
(27.3%)
Dil.: endoscopic dilation of the minor orifice
EMP: endoscopic minor papillotomy
Stent: prolonged stenting of the minor papilla
NA: not available

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observed in 11% of patients. We accept that
this might be an underestimate due to the
retrospective design of the study. Lehman et
al. reported a similar pancreatitis rate of 13%
[19]; however, rates of up to 70% have been
reported [30].
In our experience, prolonged stenting of the
dorsal pancreatic duct should be avoided
because of the risk of inducing pancreatic
damage [45, 46]. Radiographic changes
affecting the dorsal pancreatic duct occur in
26-89% of patients after prolonged stenting
[20, 24, 47, 48, 49, 50]. In the present study, 2
out of 6 patients who underwent prolonged
stent treatment prior to EMP, and another
patient, in whom a pancreatic stent was left in
place for 6 weeks after EMP, developed
pancreatic duct strictures. Stent occlusion
carries the risk of acute pancreatitis [51] and
sepsis [43]. Two out of the 89 patients
included in the present study who underwent
EMP and placement of a dorsal duct stent
developed pancreatitis due to early stent
occlusion or proximal stent migration. At our
institution, dorsal duct stents are placed after
EMP to prevent obstruction secondary to
edema and early restenosis. Our policy is to
remove the stents within 2-4 weeks if they
have not migrated into the duodenal lumen by
then.
The limited long-term response to endoscopic
interventions emphasizes the importance of
selecting patients who are likely to have a
favorable outcome. Especially for patients
who do not present with well defined bouts of
pancreatitis, non-invasive tests to predict the
outcome of endoscopic or surgical
interventions are desirable. Secretin
ultrasound studies have been used for this
purpose. In experienced hands, complete
imaging of the pancreas with transabdominal
ultrasound is possible in 75-90% of cases [52,
53, 54]. A secretin ultrasound test is
considered pathologic and indicative of true
or relative minor papillary stenosis if
prolonged dilatation of the pancreatic duct is
observed after intravenous secretin. In a study
by Warshaw et al., a positive secretin
ultrasound test predicted a positive outcome
after surgical sphincteroplasty in 92% of
patients with recurrent pancreatitis and
chronic pain [16]; the negative predictive
value of this test was reported as 75-80%
[15]. Despite these promising results, secretin
ultrasound has not gained wide acceptance in
clinical practice. Secretin is expensive, and
until recently has not been widely available
for routine use. With the recent FDA approval
of synthetic porcine secretin, it may be
worthwhile to reevaluate secretin ultrasound.
Secretin stimulated magnetic resonance
cholangiopancreatography [55] may prove to
be an alternative, but has not been evaluated
for this purpose so far. Endoscopic dorsal
duct stenting has been suggested as a
therapeutic trial prior to surgical
sphincteroplasty [21, 56, 57]. Siegel et al.
[57] reported a favorable outcome after
surgery in 10 of 15 patients who had
improved with stenting, but in only one of 5
patients who had not improved with stents.
However; the study was limited by the small
numbers and failure to demonstrate statistical
significance. As discussed above, a negative
of endoscopic dorsal duct stenting is the high
risk of inducing ductal disease.
The results of the present study confirm that,
amongst patients with symptomatic pancreas
divisum, those with acute recurrent
pancreatitis have the most favorable outcome
after EMP. In patients with recurrent
symptoms after initial response repeat
endoscopic treatment can be attempted;
however, surgical interventions may
eventually be required. Prolonged stenting of
the dorsal pancreatic duct can induce
irreversible ductal damage and should
therefore be avoided. The low overall long-
term response to EMP underlines the need for
better tests to select patients who are likely to
benefit from endoscopic therapy.
Received January 7
th
, 2004 - Accepted March
2
nd
, 2004
Keywords
Cholangiopancreatography,
Endoscopic
Retrograde;
Pancreas,
/abnormalities; Pancreatitis, /etiology,

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/prevention and control, /therapy; Recurrence,
/prevention and control; Sphincterotomy,
Endoscopic; Treatment Outcome
Abbreviations CAP: chronic abdominal pain
without associated pancreatic enzyme
elevations; EMP: endoscopic minor
papillotomy; RP: recurrent acute pancreatitis;
RP+CAP: pancreatitis with continuous pain or
incomplete relief between bout
Correspondence
Henning Gerke
Division of Gastroenterology
Department of Medicine
Duke University Medical Center
Box 3189
Durham, NC 27705
USA
Phone: +1-919.684.3894
Fax: +1-919.684.4695
E-mail address: gerke003@notes.duke.edu
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