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446 3 HEPATOBILIARY AND PANCREAS CANCER
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PCNs, more recent reports have noted an increased diagnostic
yield with CE-EUS putatively because it can detect small lesions
that could be missed on contrast enhanced CT or EUS-FNA
(Kamata etal. 2018; Zhong etal. 2019).
Radiological Features of Concern
in PCNs
There are certain radiological features that are considered to
have a high risk of harboring or predicting progression to
malignancy and therefore, these patients should be referred for
surgery. These include presence of a vascularized or enhancing
MN and MPD dilation > 1 cm as discussed later in this chapter.
There are other radiological features such as MPD dilation
>5mm, cyst size ≥3 cm, rapid growth rate (>2.75mm/year) or
thick vascularized cyst walls that are also considered important
but are not strong standalone predictors of malignancy and
warrant further investigation and closer surveillance if surgical
resection is not pursued as noted below.
Size
The size of the PCN can help guide decision-making in
management of mucinous PCNs but is not a factor when it
comes to management of non-mucinous PCNs. That is
because SCNs do not have a higher malignancy potential
regardless of their dimensions and do not need a surgical
referral unless symptomatic but SPNs are referred for surgical
resection even if they have a smaller diameter due to their
inherent risk of malignancy. On the other hand, a larger
diameter of a mucinous PCN has shown some association
with an increased risk of high-grade dysplasia or invasive cancer though the data for it remains inconclusive and an optimal
size cut-off for surgical resection remains debated. Various
surgical case series have shown a cyst size of ≥30mm can positively predict presence of high-grade dysplasia or invasive
cancer in around ~ 30% of the case (Nguyen etal. 2015; Robles
etal. 2016; Sahora etal. 2013) but other studies have not been
able to reproduce these findings (Del Chiaro et al. 2017).
Therefore, different guidelines have recommended a different
size cut-off necessitating further evaluation. The current IAP
and AGA guidelines suggest proceeding with an EUS FNA for
any mucinous cystic lesion with a size ≥30 mm whereas the
European guidelines use a cutoff of ≥40mm in IPMNs and
MCNs for consideration of surgery (European Study Group
on Cystic Tumours of the, P. 2018). Some centers strongly
consider EUS and FNA in PCNs over 2 cm in size where the
diagnosis of a non-mucinous cyst may make a difference in
management such as avoiding a long surveillance time period
in younger patients. Using the cyst diameter in conjunction
with other risk factors is considered more appropriate since it
increases the sensitivity to detect malignancy as opposed to
the cyst diameter alone (Ohtsuka etal. 2012).
Growth Rate
It has been reported that the PCN growth rate on surveillance
is a more accurate predictor for progression rather than cyst
size. Even though an increase in cyst size ≥3
mm/2 years has been noted to confer a higher risk of
>5
high-grade dysplasia or invasive cancer (5-year risk for developing malignancy is 45% for BD-IPMNs regardless of the
original cyst size) (Kang etal. 2011; Kwong etal. 2015), data
supporting this is limited. Additionally, high interobserver variability in the measurement of the cyst size (as high as 4mm)
has been noted which makes drawing conclusions from comparisons between surveillance cross-sectional imaging challenging to interpret (Dunn et al. 2016). Nevertheless, the
IPMNs and MCNs in surveillance should be further evaluated
with an EUS and FNA when cross-sectional imaging shows a
rapid increase in size.
mm/year or
Mural Nodules (MN) or Solid Component
Mural nodules are solid expressions of tumor proliferation
and presence of a MN within the PCN is one of the strongest predictors for presence of underlying high-grade dysplasia (in MD-IPMNs) or invasive cancer (in BD-IPMNs and
MD-IPMNs) with an OR 9.3 (CI 5.3–16.1) (Anand etal. 2013).
The presence of a MN within a PCN should warrant further
evaluation with an EUS ± FNA and if a question remains about
a mucin clot versus an MN, if available, CE-EUS could be considered. The dimensions of the growing MN are a result of the
neoplastic burden in the PCN and risk of malignancy seems
to be directly correlated to the size of MN. This is why new
guidelines recommend surgical resection for all PCNs with
MN ≥5mm (European Study Group on Cystic Tumours of the,
P. 2018; Kwong etal. 2015; Tanaka etal. 2017).
Dilation of Main Pancreatic Duct (MPD)
MPD dilation in IPMNs is a result of mucin produced by the
neoplastic cells in the duct walls and is thought to be an
indicator of an underlying high-grade lesion. All MD-IPMNs
warrant surgical resection but MPD in BD-IPMNs represents
somewhat of a challenge from a management perspective even
though there is some consensus that the larger the duct diameter, the higher the risk of high dysplasia and invasive cancer.
This is because most data that defines risk of malignancy in
IPMNs is from retrospective surgical case series as noted earlier in this book chapter, that fail to accurately identify the true
incidence of malignant progression in this population due to an
inherent selection bias. It is reasonable to further work-up all
such patients with MPD dilation to rule out other possible
benign and malignant etiologies such as ductal hypertension
from mucin plugging, obstructive chronic pancreatitis
(pancreatic duct stricture or stones), and solid obstructive
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tumors especially in the head of the pancreas. Even though
using MPD dilation alone to guide management decision in
patients with BD-IPMNs is fraught with a risk of possible overtreatment as stated above, most authors agree that patients with
an IPMN and MPD diameter of ≥10mm should undergo surgery if they are reasonable surgical candidates. This is supported by multiple surgical series showing a rate of ~60%
(range 36–100%) for high grade dysplasia and a rate of ~44%
(range 11–81%) for pancreatic cancer as well as a 40% risk of
IPMN related death on five-year follow up in a non-operated
cohort of patients with presumed IPMNs (Crippa etal. 2017;
Salvia etal. 2004; Suzuki etal. 2004). It is not as straightforward
for patients with an MPD diameter between 5 and 9mm where
though some studies have suggested a high risk of malignancy
of around ~ 60% (Hackert et al. 2015), others have shown a
five-year disease specific survival to be > 95% (Crippa et al.
2017). Therefore, most authors suggest further evaluation with
an EUS and FNA in this patient population. An abrupt change
in the caliber of the MPD with upstream dilation is another
concerning feature that should always warrant further investigation with an EUS and FNA as well.
Management of PCNs
Management decisions for PCNs are nuanced and it is necessary
to incorporate a multitude of factors that can influence this decision-making including clinical and radiological data as well as the
patient fitness for surgery. This is why it is of utmost importance
that the decision should be deferred to a multidisciplinary group
including gastroenterologists, radiologists, and surgeons. At baseline, all patients with a suspected PCN should get a thorough history and physical examination. Clinical variables such as patient
age, family history, presence of symptoms, other medical comorbid conditions, perceived cancer risk, and patient preference for
management should all be carefully evaluated. A dedicated
pancreatic imaging should also be performed for all patients with
a suspected PCN to evaluate for the presence of concerning features that have been described above (MRI/MRCP is preferred
though a pancreatic protocol CT is a reasonable alternative). If
there are any cross-sectional imaging characteristics of concern,
an EUS should be performed along with FNA for cytopathology,
biomarkers, and molecular testing where the expertise is available. All the information obtained should then be used to decide
about the need for ongoing surveillance versus surgical resection
of the PCN.
Surveillance
Surveillance is usually necessary for only PCNs that have a risk
of progression to malignancy. i.e., BD-IPMNs and MCNs in
patients who are surgically fit. The diagnosis of a mucinous
PCN (BD-IPMN and MCN) can remain uncertain even if EUS
and FNA is done since histopathology is usually not available.
In such cases, surveillance is continued as one would for a
mucinous PCN. Surveillance is a reasonable option for most
patients with PCNs because there is strong evidence supporting
low risk of progression and an indolent course in majority of
these lesions especially in absence of any concerning radiographic features (Arlix etal. 2012; Lawson etal. 2015; Mukewar
etal. 2017; Nagata etal. 2016). The aim of surveillance is to
recognize PCNs likely to harbor high-grade dysplasia or
pancreatic cancer and intervene early.
The optimal surveillance intervals remain controversial due to
a paucity of high-quality data. At this time, most guidelines
stratify surveillance intervals based on cyst size even though, as
stated in the chapter earlier, it is a questionable marker for predicting risk of progression to malignancy in PCNs. This because
it is the most practical PCN feature that can be utilized in this
setting. It is important to have an experienced radiologist review
high-quality imaging for all new diagnoses of PCNs to ensure
there are no concerning features such as development of a mural
nodule or solid component either within the cyst or the pancreatic
parenchyma, MPD dilation >5mm, cyst size ≥3 cm, rapid growth
rate (> 3mm/year or > 5mm/2 years) or thick vascularized cyst
walls. After this determination is made, two short term surveillance imaging in six months should be undertaken to ensure stability of the lesion. Further surveillance can then be carried out
based on the cyst size and other features as shown in Figure 2.
There are no recommendations on how long surveillance should
be continued or when surveillance should be stopped.
There are other important factors to consider for surveillance of PCNs:
1 Surveillance should be continued till the patient is no longer a
surgical candidate.
There is no good long-term data about modification of sur-
veillance intervals once the cyst stability has been demon-
strated over five years and the benefit of prolonged follow-up
in reducing cancer-related mortality has not been proven.
One study has shown a low risk of progression after five
years in such patients (Moris et al. 2017) and AGA guide-
lines even advocate for discontinuation of surveillance after
five years. But most authors agree that the risk of progression
is not reduced despite cyst stability at 5 years with data from
genetic studies demonstrating that progression can take up
between 15 and 20 years and others showing progression to
invasive cancer in BD-IPMNs up to 16 years after diagnosis
(Khannoussi etal. 2012; Yachida et al. 2010). Therefore, it
is reasonable that patients who remain surgical candidates
should continue surveillance. But it is also important to
account for new comorbid conditions and determine risks
of surgery as patients age so that surveillance can be discon-
tinued when the risks of surgery can no longer be justified.
2 There should be consistency in the use of imaging modality to
avoid variability.
An important variable that is considered when making
management decisions about PCNs is the overall cyst size
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Figure 2 A) Large IPMN with a central mass B) BD-IPMN with cancer as
seen on EUS.
and/or increase in cyst size on surveillance imaging. As discussed earlier, there is a significant variability in evaluation
of cyst size between different imaging modalities (CT vs MRI
vs EUS) (Dunn etal. 2016) and using a consistent imaging
modality can help avoid this variability that can sometimes
lead to unwarranted testing and procedures.
3
Patients on surveillance with a new diagnosis of diabetes
warrant evaluation and a closer surveillance.
New-onset diabetes in patients with IPMNs, especially in
those above the age of 50 have been noted to have increased
risk of high-grade dysplasia or pancreatic cancer (Leal etal.
2015; Mimura etal. 2010). Therefore, a short-term surveillance in six months should be considered either with MRI/
MRCP or EUS in these patients.
Patients with high-risk features detected on surveillance should
4
be referred for surgery.
Patients who are noted to have high risk features such as
MPD dilation > 1 cm, develop an enhancing MN or a solid
component in the cyst or develop obstructive jaundice on
surveillance should undergo resection. But shorter interval
surveillance (3–6 months) can be considered in patients
with the features mentioned above, who opt for increased
surveillance over surgery due to operative risk or personal
preference.
Surgery
Several factors play an important role when it comes to surgical
decision making for patients with PCNs. As mentioned previously, there are some clinical and cyst features that have a high
risk of harboring/progression to high grade dysplasia and/or
invasive cancer. These include a PCN causing obstructive jaundice, presence of a vascularized or enhancing MN, MPD
dilation >1 cm, and presence of cytology suggesting malignancy. If any of these features are present, surgical resection is
strongly considered though it must be recognized that current
guidelines and their recommendations do not have strong
scientific backing with a low specificity for predicting progression to high grade dysplasia and invasive cancer. Therefore, all
final surgical decisions should be individualized to each patient.
Consideration for the clinical features mentioned above as well
as patient-related factors such as age, life expectancy, overall
health status, and motivation for surgery should be undertaken. Type of surgery is usually determined by the location of
the PCN in the pancreas, and is also a major consideration in
this decision-making because a pancreaticoduodenectomy for
a lesion in the head of pancreas has a significantly different risk
of mortality and morbidity as opposed to a distal pancreatectomy for a lesion in the tail of the pancreas.
In cases with IPMNs or MCNs suspected to have malignant
progression, surgery should target complete removal of the
tumor along with appropriate lymphadenectomy and negative
resection margins should be ensured via intraoperative frozen
sections. Parenchyma sparing pancreatectomy is not always the
best approach for these patients due to the high risk of harboring malignancy and this is mostly reserved for resection of
cases with symptomatic SCAs.
Follow up after Surgical Resection of a PCN
Patients with surgically resected SCA, pseudocyst or other
benign cyst and MCN without an associated pancreatic cancer
do not require post-operative surveillance but all patients with
IPMN including the ones with negative surgical margins should
undergo long-term surveillance after surgery as there is a considerable risk of development of a new IPMN that will require
surgery and/or concomitant pancreatic ductal adenocarcinoma
which can develop even more than 10 years after the initial
operation (Ikeuchi etal. 2010; Sahora etal. 2016). The recurrence rates for IPMNs are reported in around 1–20% of the case
whereas the risk of malignancy is around 2–7.8% (Chari etal.
2002; Miller etal. 2011; Salvia etal. 2009; White etal. 2007).
The recommended follow up interval is shorter (6 months) for
high-risk patients such as those with family history of pancreatic
cancer and a positive surgical margin while it is longer (12
months) for other patients (Tanaka etal. 2017). This is thought
to be a result of the “field defect” mentioned earlier in the
chapter present in the entire pancreatic parenchyma that predisposes the remnant to development of new IPMNs, progression of any remaining IPMNs or development of concomitant
pancreatic cancer.
Endoscopic Ablation
The variable clinical behavior and morbidity of surgical
approach for PCNs makes it necessary to venture into minimally invasive options for treatment of PCNs. Along these
lines, endoscopic ultrasound guided ablation of the PCNs has
been investigated using ethanol alone or ethanol followed by
the instillation of the chemotherapy agent paclitaxel. Paclitaxel
works by stabilizing microtubules thus inhibiting cell replication and is hydrophobic which improves retention in the cyst
by decreasing peri-cystic leakage. The results have been mixed
with varying degrees of success including imaging guided cyst
resolution rates of around 33–79% of the cases and varying
22 MANAGEMENT OF CYSTIC NEOPLASMS OF THE PANCREAS 449
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degrees of epithelial ablation on histopathology of resected
specimens (DeWitt etal. 2009; DiMaio etal. 2011; Gan etal.
2005; Gomez et al. 2016; Moyer et al. 2016). The technique
is in infancy stages with multiple issues that still need to be
sorted out including concerns with incomplete epithelial infiltration from the ethanol as well as need for ongoing surveillance imaging once the cyst has collapsed which is challenging.
Additionally, there are no data supporting eradication of the
risk of malignant progression with decreasing cyst size and
development of pancreatic ductal adenocarcinoma (PDAC) at
the site of a previously treated BD-IPMN after 41 months of
follow up has been reported (Gomez etal. 2016). Complication
rates are reported in around ~12% of the cases and include
fever, abdominal pain, pancreatitis, peritonitis, and splenic
vein obliteration (DeWitt etal. 2014; Gan etal. 2005; Oh etal.
2008). Due to the reasons mentioned above, routine use of EUS
guided ablation of the PCNs is currently not recommended and
should only be considered at large volume centers in patients
who refuse surgery or are high risk surgical candidates. This
should ideally be done in a clinical trial setting to obtain more
data on appropriate technique and materials as well as on the
long-term outcomes of this procedure.
EUS guided radiofrequency ablation (RFA) has also been
evaluated in a few human case series but has mostly been
limited to patients with pancreatic cancer and pancreatic
neuroendocrine tumors. A small study has evaluated EUS
guided RFA for PCNs in six patients (4 with mucinous cysts,
one with BD-IPMN and 1 microcystic adenoma) and demonstrated image guided resolution in two cases and a ~50%
decrease in size in three of the cases (Pai etal. 2015). Reported
adverse outcomes were self-limiting abdominal pain in two
patients. While these results are promising, more research on
this technique is needed before a verdict can be reached on
its efficacy.
Comparison of Different Society
Guidelines for Management of
Pancreatic Cystic Neoplasms
Different organizations have published guidelines on management
strategies for patients with PCNs. Even though there are remarkable similarities between most of these guidelines, which is
reassuring, there are some notable differences which is why the
authors of this chapter felt that including a summary about these
is necessary. Most guidelines focus on management of incidentally discovered pancreatic cystic lesions such as ACG, AGA,
ASGE, European guidelines, and American college of radiology
guidelines. The revised Fukuoka guidelines, which are the most
comprehensive in the authors’ opinions, only focus on IPMNs.
Major differences include when to recommend for evaluation with EUS-FNA and surgical resection . Studies have also
attempted to compare these guidelines in their ability to recognize high risk PCNs using surgically resected specimens as the
gold standard. The respective accuracy, sensitivities, and specificities of the guidelines are: AGA guidelines 2015 – 49.6%, 23.5%
and 84.3%, Revised Fukuoka guidelines 2017 – 41.2%, 39.7% and
43.1%, and European guidelines 2018 – 58%, 67.7% and 45.1%
respectively (Ardeshna etal. 2022). The suggested algorithm currently used at the author's institution for management of PCNs is
displayed in Figure 3 below.
Conclusion
Pancreatic cystic neoplasms have increased in incidence over
the years and represent a major diagnostic and management
dilemma for gastroenterologists, resulting in significant uncertainty and anxiety to patients and providers. A large majority
of these PCNs are BD-IPMNs and the current evidence for
management is severely lacking in high quality research.
Regardless, it is imperative that all management decisions should
be tailored to individual patients based on their specific clinical
factors, radiographic features of their PCN, and their surgical
candidacy. More prospective multicenter studies evaluating different management approaches as well as innovation in the currently available techniques for the accurate diagnosis of PCNs are
much needed to help streamline decision making in this challenging field.
Key Take Home Messages
• Only mucin producing PCNs (MCNs and IPMNs) have a
clinically relevant risk of malignant transformation
• Most controversy surrounds management of BD-IPMNs
since differentiation from other types of PCNs is challenging and there is paucity of high-quality data for optimal
management.
• Identification of SPNs, MD-IPMNs, pNETs and larger
MCNs is less challenging and the accepted approach is
surgical resection if the patient is a suitable candidate
Areas for Further Research
Improved non-invasive surveillance methods for medium risk
lesions
Chemopreventive regimens for low risk lesions
Trusted Websites for Further Reading
https://www.pancreaticcancer.org.uk/information/just-diagnosed-
with-pancreatic-cancer/pancreatic-cysts
https://www.mayoclinic.org/diseases-conditions/pancreatic-
cysts/diagnosis-treatment/drc-20375997
450 3 HEPATOBILIARY AND PANCREAS CANCER
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Yes
Surgical candidate
No
No more studies
Yes
Surgery
MRI of remnant
pancreas every 2
years
< 2cm
MRI in
6 months X1, then annually until no longer a
surgical candidate
*Any high-risk stigmata: 1)Obstructive jaundice, 2) mural nodule≥5 mm, 3) main duct
Yes
≥10 mm 4) Clinically symptomatic
* Order MRI/MRCP for cyst≥1.5 cm if not previously done
No
Worrisome features
Clinical:1) pancreatitis, 2) new onset or exacerbated diabetes, 3)
unintended weight loss,
Imaging: 1) cyst ≥3cm 2) mural nodule any size, 3) enhancing cyst walls,
4) pancreatic duct caliber change and distal pancreatic atrophy, 5) cyst
size increase ≥ 3mm over serial studies
Yes, EUS: fluid for CEA,glucose,cytology;
cyst wall or nodule (When possible) for path
High risk EUS stigmata:
1) mural nodule ≥5 mm
2) main duct features
3) + cytology (suspicious or positive
for malignancy)
then annually unless no longer a surgical candidate. Surgery always
an option in appropriate candidates.
No
No
≥ 2cm
MRI in 6 months X2,
No
Figure 3 Suggested Algorithm for management of pancreatic cystic lesions (Adapted from Tanaka et al., 2017).
Conflict of Interest Statements
Umar Hayat MD: The author has no significant conflicts of
interest with any companies or organization whose products or
services may be discussed in this article.
Mahnur Haider MD, MPH: The author has no significant
conflicts of interest with any companies or organization whose
products or services may be discussed in this article.
Amitabh Chak MD: Amitabh Chak is a consultant for US
Endoscopy, a subsidiary of Steris, Inc.
Brooke Glessing MD: The author has no significant conflicts of interest with any companies or organization whose
products or services may be discussed in this article.
Funding sources: None
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