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B. Shakhsheer and J. Alverdy
475© Springer International Publishing Switzerland 2016
J.M. Millis, J.B. Matthews (eds.), Diffi cult Decisions in Hepatobiliary
and Pancreatic Surgery, Diffi cult Decisions in Surgery: An Evidence-Based
Approach, DOI 10.1007/978-3-319-27365-5_42
Chapter 42
Surgery or Endotherapy for Large Duct
Chronic Pancreatitis
Jason B. Liu and Marshall S. Baker
Abstract For chronic pancreatitics who have a glandular morphology character-
ized by a dilated main pancreatic duct, pain is thought to be due to ductal hypertension and glandular/capsular stretch. Decompression of the pancreatic duct by either
endoscopic transampullary stenting or surgical drainage is the principle method of
treating symptoms in these patients. Surgical intervention is commonly thought to
carry increased risk of perioperative morbidity, thus current practice involves an
intervention sequence starting with endoscopic stenting and falling back to surgery
in cases of recalcitrant pain. There is, however, little evidence to argue that an
“endoscopy fi rst” approach is better than early surgical intervention. Few studies
prospectively examine outcomes of endoscopy compared to surgery in terms of pain
relief, morbidity and mortality, number of repeated interventions, and preservation
of pancreatic function. The evidence that is available suggests surgical management
of large duct chronic pancreatitis results in better long term outcomes when compared to endoscopic therapy without incurring prohibitive risk of signifi cant perioperative morbidity. In our view, surgical drainage of the pancreas should be considered
as a primary method of managing patients with chronic pancreatitis and a dilated
main pancreatic duct.
Keywords Chronic pancreatitis • Endoscopy • Surgery • Outcomes • Large duct
J. B. Liu
Department of Surgery , University of Chicago, Pritzker School of Medicine ,
5841 S. Maryland Ave. Rm O-217 MC6040 , Chicago , IL 60637 , USA
e-mail:
jason.liu@uchospitals.edu
M. S. Baker (
*)
Department of Surgery, Division of Surgical Oncology , University of Chicago, Pritzker
School of Medicine , 5841 S. Maryland Ave. Rm O-217 MC6040 , Chicago , IL 60637 , USA
NorthShore University Health System , 2650 Ridge Ave. Walgreen Bldg., 2nd fl oor ,
Evanston , IL 60201 , USA
e-mail:
mbaker3@northshore.org
476
Introduction
Pain is the symptom leading to treatment in patients with chronic pancreatitis. For
some patients, obstruction of the main pancreatic duct by stones or by progressive
fi brosis in the pancreatic head results in a marked dilation of the main pancreatic
duct. Ductal and parenchymal hypertension and capsular stretch are purported to be
the major etiologic factors of pain in these patients. In later stages of the disease, the
pain may be neuropathic in nature, driven by nerve injury from repeated bouts of
retroperitoneal infl ammation.
Endoscopic or surgical decompression of the pancreatic duct is the mainstay of
therapy for chronic pancreatitics with dilation of the main pancreatic duct. Both
methods aim to alleviate pain by promoting adequate drainage of the pancreas
thereby relieving ductal and parenchymal hypertension. To date, there is no clear
consensus as to which modality is superior in relieving pain and improving quality
of life , or as to when to use one approach over the other. In general, current practice
involves a conservative “step up” approach in which patients are fi rst managed medically with diet modifi cation (e.g. alcohol abstinence, low fat diet, enzyme supplementation), then endoscopically with transampullary stenting, and are lastly referred
to consider surgery when other modes of therapy fail to alleviate or control pain.
There is little evidence to suggest that this is the most effi cacious way to manage
these patients. Longitudinal studies show that of all patients with chronic pancreatitis, up to 75 % will require surgical management at some point during the course of
their disease [ 1 , 2 ]. Prospective studies evaluating endoscopic methods in isolation
fi nd these methods to be safe, technically successful and achieve long-term pain
relief. Similar claims are made for surgical therapies when examining resection ,
decompression and hybrid resection-drainage procedures in isolation [ 2 – 9 ].
This chapter attempts to answer the question which mode of therapy, early endoscopic or surgical intervention for patients with large duct chronic pancreatitis, is
best by means of an evaluation of the literature focused on studies that offer comparisons between endoscopic and surgical approaches.
Search Strategy
A literature search was performed to identify relevant studies comparing the outcomes of endoscopic and operative interventions in the treatment of large duct
chronic pancreatitis. A PICO approach was constructed for the search (Table
42.1 ).
English language publications between August 1, 2000 and August 1, 2014 involving adult patients aged 18 years or older were queried from the following databases:
PubMed, Science Citation Index/SCI-Expanded, and Cochrane Evidence Based
Medicine . A combination of the following terms in their various forms were used to
complete the search: “chronic pancreatitis,” “ surgery ,” “ endoscopy ,” “extracorporeal shockwave lithotripsy,” “drainage,” “decompression,” “outcomes,” “ pain ,”
J.B. Liu and M.S. Baker
477
“Izbicki pain score,” “ pancreatectomy ,” “ resection ,” “endocrine function,” and
“exocrine function.” Articles were excluded if they examined either surgical therapies alone or endoscopic therapies alone. One paper was exempt from the publication date limitation due to its relevance to the discussion and was included. In all,
three randomized controlled trials, six cohort studies, three review articles, two systematic reviews, and one study protocol were evaluated. The data was classifi ed
using the GRADE system. A summary of discussed data is provided in Table 42.2 .
Results
Pain Relief
In general, comparative studies have demonstrated that both endoscopic and surgical methods of pancreatic duct drainage provide effective improvement in patients’
symptoms with most studies demonstrating an advantage to surgical intervention
with regard to both initial rates of improvement in symptoms and durability of the
response.
The North American Pancreatitis Study 2 (NAPS2) was a prospective, 20-center
case-control study of 1000 recurrent acute pancreatitis and chronic pancreatitis
patients in the United States in which standardized questionnaires were used to
capture information on the use and effectiveness of medical, endoscopic , and surgical therapies. Gland morphology was not considered in this study. The authors analyzed their cohort of patients who only had chronic pancreatitis with regard to the
frequency of endoscopic and surgical therapies, and their subjective effectiveness
[ 5 ]. Of the 515 patients studied, 185 (35.9 %) underwent endoscopic pancreatic duct
stenting with reported effectiveness in 87 (47 %) patients. Fifty-one (9.9 %) patients
underwent a surgical drainage procedure, which was effective in 36 (70.6 %)
patients. Overall, endotherapy was considered effective in 42.8 % of patients compared to 68.5 % in patients treated with either surgical drainage or resection
(p < 0.0001). Surgical procedures, however, were performed less frequently than
endoscopic procedures (32.8 % vs. 60.8 %, p < 0.0001). Studying their group of
patients that participated in NAPS2, Clarke et al. reported that endoscopically managed patients achieved clinical success in 51 % of patients [ 6 ]. Of those who failed
endotherapy and subsequently underwent surgery , 50 % had successful outcomes .
The NAPS2 did not record the specifi c symptom being treated with each procedure,
Table 42.1 PICO table for management of large duct chronic pancreatitis
P (Patients)
I
(Intervention)
C
(Comparator) O (Outcomes)
Patients with large
duct chronic
pancreatitis
Surgery Endoscopy Pain relief, morbidity/ mortality, need
for repeated interventions, progression
to endocrine/exocrine insuffi ciency
42 Surgery or Endotherapy for Large Duct Chronic Pancreatitis
Table 42.2 Summary of clinical outcomes comparing surgery and endoscopy in the treatment of large duct chronic pancreatitis
Author
Year
N
Follow up (months)
Pain relief
b
Morbidity
Mortality
Repeated
intervention
d
Endocrine
insuffi ciency
f
Exocrine
insuffi ciency
f
Quality of evidence (grade)
Endoscopy
Surgery
p
Endoscopy
Surgery
p
Endoscopy
Surgery
p
Endoscopy
Surgery
p
Endoscopy
Surgery
p
Endoscopy
Surgery
p
Clarke 2012 146 96 51 % 50 % NR 12 % NR NR 0 % NR NR – – – – – – – – – Very low
Cahen 2007 39 24 32 % 75 % 0.007 58 % 35 % 0.15 5 % 0 % 0.49 8 (1–21) 3 (1–9) <0.001 17 % 5 % 0.48 33 % 5 % 0.05 Moderate
Cahen 2011 31 79 38 % 80 % 0.042 – – – – – – 2 (0–43) 0 (0–20) 0.51 44 % 20 % 0.32 38 % 13 % 0.13 Moderate
Dite 2003 72 60 15 % 33.8 % 0.002 8 % 8 % NR 0 % 0 % NR 6 (4–9) 1 (1–3) NR 34.2 % 38.8 % NR 28.6 % 47.2 % 0.003 Low
Glass 2014 515 72 38.8 % 69.6 % <0.0001 – – – – – – – – – – – – 39.8 % 67.2 % 0.0008 Very low
Hirota
c
2011 68 40 0.21 0.16 NS – – – – – – – – – – – – – – – Low
Hong 2011 62 60 47 % 77 % 0.04 7 % 14 % 0.66 0 % 3 % 1 2 (1–4) 1 (1–2) <0.001 65 % 87 % 0.16
g
54 % 29 % 0.17 Low
Rutter 2010 292 58 – – – 32 % 32 % NA 0 % 5 % NA 2.1 0.43 <0.001
e
– – – – – – Low
Non - Op Non - Op Non - Op
Nealon
a
1993 32 47 13 % 94 % <0.001 – – – – – – – – – 15 % 83 % 0.001 7 % 79 % <0.001 Low
NR not reported, NS not signifi cant, Non-Op : non-operative management
a
Secondary analysis from [ 9 ]
b
Percentage of partial and complete pain relief
c
Incidence of acute pancreatitis per person-year
d
Median (range)
e
Comparison between means
f
New onset endocrine or exocrine insuffi ciency unless otherwise specifi ed
g
Preservation of independent endocrine function
479
and effectiveness was reported as the interpretation of the treating physician. There
was little effort to control for disease morphology – to limit the study to patients
with diffuse dilation of the main pancreatic duct and no pancreatic head mass. There
was also a relatively limited effort to use standardized methods to assess pain in
these studies.
A smaller retrospective study of 62 patients with chronic pancreatitis and main
pancreatic duct dilation treated with either endoscopic intervention or surgical
drainage calculated the Izbicki pain scores before and after intervention [ 7 ]. They
demonstrated a signifi cant difference in complete or partial pain relief over a 5-year
follow up period in those who underwent surgery (77 % vs 47 %, p = 0.04).
Very few prospective randomized studies have compared the outcomes of medical and surgical management of chronic pancreatitis patients with regard to pain .
The earliest study reported by Nealon and Thompson was done at a time when
endoscopic procedures had not been fully developed [ 8 ]. This study randomized
17 patients with mild/moderate pancreatitis and non-debilitating abdominal pain
to either non-operative (medical, non-endoscopic intervention) or operative management with a mean follow up period of 39 months. One quarter of patients in the
non-operative group remained with mild/moderate pancreatitis while the others
progressed to more severe symptoms. Seventy-eight percent of patients in the
operated group remained with mild/moderate pancreatitis at the end of follow up.
Unfortunately, no objective measures of pain were used in this study. Substantial
pain relief was reported in 16/17 (94 %) patients in the surgical group compared
to only 2/15 (13 %) patients in the non-operative group [ 9 ]. At a time in which
endoscopic decompression was not readily available, the investigators concluded
that surgical ductal decompression delayed the progression of chronic
pancreatitis.
In 2003, Dite et al. published a pseudo-randomized (i.e. 1:1 alternating patient
allocation) prospective study of 72 patients embedded in a cohort of 140 patients
[ 10 ]. All patients had failed medical management for at least 3 years. Endoscopy did
not utilize extracorporeal shock wave lithotripsy, and surgery entailed both drainage
and resection procedures. At 5-year follow up, complete pain relief as assessed by
the Melzack score was achieved in a greater number of patients who underwent
surgery compared to endotherapy (34 % vs. 15 %, p = 0.002).
The most well done prospective randomized trial was carried out by Cahen et al.
and published in the New England Journal of Medicine in 2007 [ 11 ]. For this study,
the authors randomized 39 patients with advanced chronic pancreatitis and proximal obstruction of the pancreatic duct without pancreatic head enlargement to multimodal endoscopic therapy or operative decompression. The primary end point was
the average Izbicki pain score during a median of 24 (range 6–24) months of follow
up. Patients who underwent surgery reported an Izbicki pain score signifi cantly
lower than those who underwent endotherapy (mean difference 24, 95 % confi dence
interval [CI], 11–36, p < 0.001). Moreover, after surgical drainage, pain relief was
present by 6 weeks postoperatively and persisted during the follow up period.
Complete or partial pain relief was achieved in 32 % of patients in the endoscopy
group and 75 % of patients in the surgery group (p = 0.007). The study was prema-
42 Surgery or Endotherapy for Large Duct Chronic Pancreatitis
480
turely terminated on the basis of a signifi cant difference in outcome favoring the
surgical group. After 79 months of follow up, 31 of the 39 patients were re- evaluated
[ 12 ]. The Izbicki pain score difference in favor of the surgical group was no longer
signifi cant (39 vs. 22, p = 0.12). However, the secondary outcome measure of either
partial or complete pain relief was still signifi cantly higher in the surgically treated
group (80 % vs. 38 %, p = 0.042).
A more recently published Cochrane review pooled the data from these two randomized studies [ 9 ]. Of the 111 patients, surgery achieved a higher proportion of
patients with pain relief compared to endoscopy (RR 1.62, 95 % CI, 1.22–2.15).
The proportion of patients with complete pain relief was higher in the surgical group
(RR 2.45, 95 % CI, 1.18–5.09), but there was no difference in the proportion of
patients with partial pain relief.
Morbidity and Mortality
Proponents of endoscopic management of chronic pancreatitis cite high morbidity
and mortality in those undergoing surgical intervention as the primary reason for
pursuing endoscopy prior to or in place of surgery . Both comparative studies and
longitudinal examinations of endoscopic and surgical drainage in isolation generally support the contention that the absolute risk of peri-procedure morbidity is
higher in the surgically treated patients. But, there is no clear indication from the
existing literature that the increased morbidity is prohibitive or that it justifi es an
“endoscopy fi rst” or “endoscopy alone” approach to these patients.
In their cohort of endoscopically managed patients, Clarke et al. reported an
overall complication rate of 12 % of which 59 % were hospitalizations for postprocedure monitoring [ 6 ]. There were no deaths. In a retrospective study of 292
patients with chronic pancreatitis of any morphology, Rutter et al. reported an
equivalent complication rate of 32 % between patients treated by endoscopy and
by surgery [ 13 ]. Infectious complications were more common in patients managed surgically (14.1 % vs. 0.7 %, p < 0.001), while acute on chronic pancreatitis
and formation of pseudocyst were more often seen in patients after endoscopic
treatment (14.7 % vs. 5.1 % and 14.7 % vs. 10.1 %, respectively). Hong et al.
noted a trend toward increased rates of complication following surgical management , but that trend did not achieve statistical signifi cance (14 % vs. 7 %,
p = 0.66) [ 7 ].
Similarly, Dite et al. reported 8 % morbidity and no mortality in both their endoscopic and surgical groups when they combined their randomized and nonrandomized groups [ 10 ]. Cahen et al. also demonstrated no signifi cant difference in
morbidity and mortality between the endoscopic and surgical groups (58 % vs.
35 %, p = 0.15 and 5 % vs. 0 %, p = 0.49, respectively) [ 11 ].
None of these studies formally grade the complications that happen following
either endoscopic or surgical interventions. Given this, we have a very limited
understanding of the true burden that these procedures bring to patients.
J.B. Liu and M.S. Baker
481
Repeated Interventions, Hospitalizations, and Costs
The need for repeated interventions, prolonged hospitalization, and increased costs
have been identifi ed as potential disadvantages to endoscopic therapy. Rutter et al.
reported patients with an initial surgical intervention had the fewest consecutive
interventions compared with endotherapy [ 13 ]. Of the 99 surgically treated patients,
13 (13 %) required a second intervention, and 9 (9 %) required up to four interventions. Of the 150 endoscopically managed patients, 47 (31 %) patients needed a
second intervention and 63 (42 %) patients received up to 12 interventions. Patients
with an initial surgical intervention had the lowest number of subsequent interventions compared with patients who had an initial endoscopic intervention (mean
number, 0.43 vs. 2.1, p < 0.001). Furthermore, the intervention-free interval was signifi cantly longer after initial surgical treatment compared with endotherapy (mean
months, 18.8 vs. 4.8, p < 0.001). Patients treated endoscopically spent a signifi cantly
greater number of days hospitalized compared to those who underwent surgery
(mean days, 25.3 vs. 34.4, p < 0.001). However, the single mean admission time in
patients with surgical treatment was longer than those who received endoscopic
therapy (mean days, 20 vs. 10.7, p < 0.001).
A small retrospective study of 65 patients with chronic pancreatitis and main
pancreatic duct dilation treated with either endoscopic or surgical drainage done by
Hirota et al. reported no difference between groups in the number of total hospitalized days per year (29.3 vs. 18.6, p = 0.055) over an average follow up period of 40
months [ 14 ]. However, the number of hospitalizations per year was signifi cantly
more frequent in those treated endoscopically compared to those managed surgically (1.6 vs. 0.67, p < 0.001). They did not report the indications for repeated hospitalizations. Hong et al. were able to demonstrate similar results [ 7 ]. They reported
a signifi cantly greater number of interventions in the endoscopy group compared to
the surgery group (median number of procedures, 2 vs. 1, p < 0.001). Although
patients undergoing endotherapy had a shorter initial hospital stay (mean days, 12
vs. 28, p < 0.001), they had a signifi cantly greater number of readmissions at 5-year
follow up compared to the surgical group (median, 2 vs. 0, p < 0.001).
Interestingly, when Hirota et al. stratifi ed their endoscopy group into patients that
required endoscopic therapy for shorter than or longer than 1 year, they noted that
patients who required endoscopic therapy for longer than 1 year had signifi cantly
greater annual hospitalized days (41.3 vs. 18.6, p = 0.0016), more frequent annual
hospitalizations (2.5 vs. 0.67, p < 0.0001), and incurred greater annual costs ($20,300
vs. $10,200, p = 0.0027) [
14 ]. They concluded endoscopic therapy should not persist
past 1 year of therapy before considering surgery .
Dite et al. reported an average of six endoscopic interventions per patient (range
4–9) compared to one surgical intervention per patient (range 1–3) [
10 ]. When
including the initial endoscopic or surgical intervention, Cahen et al. reported more
overall diagnostic and therapeutic interventions in the group treated with endotherapy compared to the group treated with surgery (median, 8 vs 3, p < 0.001) [ 11 ].
This trend continued to hold true at their long-term analysis (median, 12 vs. 4,
p = 0.001) [ 12 ]. There was no difference in median hospital length of stay (13 vs. 11,
42 Surgery or Endotherapy for Large Duct Chronic Pancreatitis
482
p = 0.33), rate of readmission (2 vs. 0, p = 0.194), or costs ($31,048 vs. $25,042,
p = 0.29). Nine (47 %) patients treated initially with endoscopy underwent surgical
intervention at the time of the long-term analysis.
Endocrine and Exocrine Insuffi ciency
Disease progression results in exocrine and endocrine insuffi ciency. Both endoscopic and surgical modalities have been shown to delay the progression of pancreatic insuffi ciency. Some studies have demonstrated an advantage to surgery
compared to endoscopy in terms of the time to exocrine insuffi ciency. Others have
shown no advantage.
In the NAPS2 cohort, Glass et al. reported perceived improvement in exocrine
insuffi ciency in patients treated with surgery compared to endoscopy (93 % vs.
55 % over 5 years of follow up, p = 0.0008) [ 5 ]. However, Hong et al. demonstrated
no signifi cant difference in either endocrine or exocrine preservation or deterioration at 12-month or 60-month follow up (Table 42.2 ) [ 7 ].
As mentioned earlier, Nealon and Thompson evaluated the outcomes of pancreatic function in patients undergoing operative management compared to medical
management [ 8 ]. Their grade of disease was based wholly upon endocrine and exocrine function. New onset endocrine and exocrine pancreatic insuffi ciency were
respectively observed in 2/13 (15 %) patients and 1/15 (7 %) in the surgery group
compared to 10/12 (83 %) patients and 11/14 (79 %) patients in the non-operative
group [ 4 ]. They did not report the time to diagnosis of new insuffi ciency during their
follow up period.
Dite et al. examined body weight changes and new onset diabetes mellitus during
their 5-year follow up period [ 10 ]. Patients who underwent surgery gained signifi -
cantly more body weight compared to those who underwent endotherapy (47.2 % vs
28.6 %, p = 0.003). There was no difference in new onset diabetes mellitus between
groups. Cahen et al. reported preservation of exocrine function in patients who
underwent surgery, but no difference in new onset endocrine insuffi ciency between
groups [ 11 ]. A pooled analysis also demonstrated no signifi cant difference in endo-
crine insuffi ciency between surgical and endoscopic management (RR 0.98, CI
0.55–1.76). Long-term analysis by Cahen et al. trended towards a greater loss of
pancreatic exocrine and endocrine function in the endoscopy group but this was not
signifi cant [ 12 ].
Timing of Intervention
Few studies have adequately compared surgical to endoscopic therapy head-to-head
with the intent to identify appropriate timing of intervention. Most patients with
chronic pancreatitis present for intervention late in the course of the disease and are
a heterogeneous group in terms of glandular morphology. Nealon and Thompson
J.B. Liu and M.S. Baker
483
were the fi rst to demonstrate early surgical intervention in patients with mild to
moderate disease had better pain control and sustained pancreatic function relative
to best medical management [ 8 ]. A more recent study by Ahmed Ali identifi ed sur-
gery within 3 years of the onset of symptoms, fewer than fi ve previous endoscopic
treatments, and the absence of preoperative opioid use as independent factors associated with achievement of greater postoperative pain relief [ 15 ]. The two currently
available randomized studies by Dite et al. and Cahen et al. seem to show improved
results from surgery but also identify a benefi t in select patients treated with endoscopy alone. From the available data we can surmise that surgical intervention early
in the disease course might mitigate disease progression, reduce pain durably, and
slow deterioration of pancreatic function. There is, however, probably a cohort of
patients that would benefi t permanently from one or two transampullary stenting
procedures. Unfortunately no consensus as to the sequence or the timing of endoscopy and surgery presently exists. The Dutch Pancreatitis Study Group is currently
recruiting patients for the ESCAPE trial (Early Surgery versus Optimal Current
Step-Up Practice for Chronic Pancreatitis trial; ISRCTN 45877994), which will
help to answer the question of whether early surgical intervention improves pain
control and pancreatic function compared to the current “step up” approach [ 4 ].
Recommendations
Quality evidence includes only patients with severe late-stage chronic pancreatitis.
This is a heterogeneous population of patients with variable glandular morphology,
degrees of fi brosis and calcifi cation, and narcotic addiction. The available studies
are themselves also variable in terms of the way pain assessments are made, and the
types of endoscopic and surgical interventions evaluated. Nevertheless, most investigations would support the contention that endoscopic drainage offers less durable
symptom relief in patients with advanced chronic pancreatitis and a dilated main
duct compared to surgical management (evidence quality moderate). Patients managed endoscopically require more repeated interventions than patients who undergo
early surgical intervention. This translates to more hospitalization days and to
greater costs. There appears to be no difference in the morbidity and mortality
between each method (evidence quality low). There is no long-term difference in
the preservation of endocrine and exocrine function (evidence quality low). Our
recommendation is to consider surgical decompression for dilated duct chronic pancreatitis early in the course of its management.
A Personal View of the Data
The pain associated with chronic pancreatitis is debilitating. For patients with a diffuse dilation of the main pancreatic duct, surgical and endoscopic decompression
can offer signifi cant improvement in symptoms and allow patients to return to high
42 Surgery or Endotherapy for Large Duct Chronic Pancreatitis