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454
weeks since a direct correlation exists between success of endoscopic intervention
and degree of encapsulation [ 9 ] and early intervention is associated with poor out-
comes [ 10 ].
Over the last few years, few studies have reported that even selected patients with
infected WON who are clinically stable, can be managed without debridement with
supportive care, antibiotics and percutaneous drainage [ 11 – 13 ]. Prior to advent of
endoscopic drainage, symptomatic WON was traditionally managed by surgical
debridement, which usually required multiple sessions and had signifi cant morbidity including organ failure, external fi stulas, and incisional hernias. Endoscopic
necrosectomy must be avoided till a well-defi ned capsule has developed and success of debridement has been shown to be directly associated with the degree of
encapsulation [ 14 , 15 ]. Besselink et al. [ 16 ] showed that mortality after surgical
necrosectomy in patients with necrotizing pancreatitis (more than 80 % with
infected necrosis) decreased signifi cantly with increasing the time interval from
initial admission (8 % vs. 45 % vs. 75 % for more than 30 days, 15–29 days and
1–14 days respectively; p < 0.001).
Which Modality to Choose
The Diminishing Role of Open Necrosectomy
Open necrosectomy with wide drainage and placement of abdominal drains for
lavage was the most common approach for patients with infected pancreatic necrosis . This usually required repeat interventions and was associated with signifi cant
morbidity 34–95 % and mortality ranging from 11 to 50 % [ 17 – 22 ]. The re-
intervention rates in high volume series from Europe and the United States have
been high 30–70 %. A study from Fernandez del Castillo et al. in which 167 patients
with suspected pancreatic necrosis underwent single step debridement and abdominal closure were noted to develop post operative pancreatic fi stula s in 41 %, enteric
fi stulas in 15 %, endocrine pancreatic insuffi ciency in 16 % and exocrine insuffi ciency in 20 % patients. Post-operative intensive care unit stay was needed in 57 %
patients [ 18 ]. Even though there is no prospective comparison between open and
laparoscopic necrosectomy, Tan et al. retrospectively reviewed their data of 76
patients with severe acute necrotizing pancreatitis who underwent either open or
laparoscopic necrosectomy and showed that laparoscopic group was associated
with signifi cantly lower complications (including pancreatic fi stulae, infections)
and length of hospitalization. There was however no difference in overall mortality
in the two groups [ 23 ]. Bakker et al. compared surgical necrosectomy with endo-
scopic transgastric necrosectomy in a randomized controlled trial (ten patients in
each group) [ 24 ]. They showed that patients undergoing endoscopic necrosectomy
had lower systemic infl ammatory response as measured by IL-6 levels (p = 0.004)
and also lower composite clinical end point of major complications including new
A. Singh and A. Gelrud
455
onset organ failure, pancreatic/enterocutaneous fi stula, intra-abdominal bleeding or
death (20 % vs. 80 %, risk difference 0.60, 95 % CI 0.16–0.80, p = 0.03).
A meta-analysis of comparative studies (one randomized and three clinical controlled trials) published by Cirocchi et al. compared open necrosectomy (ON) with
minimally invasive necrosectomy (MIN) in patients with infected pancreatic necrosis (total of 336 patients, 215 with MIN and 121 with ON) [ 25 ]. MIN included lapa-
roscopic transperitoneal, retroperitoneal as well as endoscopic procedures. They
showed that MIN was associated with signifi cantly lower incidence of multi-organ
failure (OR 0.16, 95 % CI 0.06–0.39, p < 0.001), surgical reintervention (OR 0.16,
95 % CI, 0.00–3.07, p = 0.19), incisional hernias (OR 0.23, 95 % CI 0.06–0.90,
p = 0.03), new onset diabetes (OR 0.32, 95 % CI 0.12–0.88, p = 0.03) and need for
pancreatic enzymes (OR 0.005, 95 % CI 0.04–0.57, p = 0.005) compared to open
necrosectomy. There was also trend towards lower mortality , intra-abdominal bleeding, pancreatic fi stula and entero-cutaneous fi stulae formation after MIN but these
did not achieve statistical signifi cance. Signifi cant heterogeneity amongst the
included studies was a major limitation of this analysis.
Minimally Invasive Necrosectomy (MIN)
Even though there is data to show the MIN is associated with better outcomes compared to open surgical necrosectomy, there is wide variation in the technique for
MIN depending on the route and instrumentation used. These techniques include
laparoscopic necrosectomy (trans or intraperitoneal), retroperitoneal necrosectomy
(video assisted retroperitoneal debridement or sinus tract endoscopy with debridement) and percutaneous approach. The instruments used for these can include laparoscopes, fl exible endoscopes and nephroscopes. Hence the published data for MIN
is severely limited by lack of randomized trials, small numbers of patients and
marked heterogeneity in the techniques.
Laparoscopic Necrosectomy
Laparoscopic necrosectomy was fi rst described by Gagner et al. in 1996 [ 26 ]. In the
fi rst published series of laparoscopic intraperitoneal necrosectomy in 2000, Zhu
et al. performed laparoscopic debridement in ten patients followed by large volume
peritoneal lavage for 7–14 days [ 27 ]. Interestingly all surgeries were done within
24–72 h after disease onset and they reported 30-day mortality of 30 % without any
other major complications ( pancreatic fi stula , abscess or bleeding). Another retrospective series was published from China by Zhou et al. in 2003 in which laparoscopic debridement was done in patients with early as well as later stage of severe
acute pancreatitis with 92 % resolution of collections at 6 months following 2–7
weeks of drainage [
28 ]. Parekh for the fi rst time in 2006, published a retrospective
40 Endoscopic or Minimally Invasive Debridement of Walled-Off Pancreatic Necrosis?
456
series of 19 patients with persistently symptomatic or infected pancreatic necrosis
who underwent hand assisted laparoscopic debridement [ 29 ]. All procedures were
done at least 3 weeks after onset of symptoms (median 65 days). One patient
required conversion to open surgery while two others required open surgery during
follow-up and there were two deaths. Pancreatic fi stulae developed in 11 out of 14
patients treated primarily with laparoscopic intervention.
Repeat surgery is needed in up to 20 % of patients and external drainage is
needed in majority of the patients undergoing laparoscopic debridement (range 9
days–7 weeks based on studies in Table 40.2 ) [ 27 – 29 ]. There is also high incidence
of pancreatic fi stula formation though lower than that associated with open debridement. Laparoscopic cholecystectomy can be done at the same time as laprascopic
necrosectomy. In a systematic review of minimally invasive necrosectomy , Babu
et al. [ 30 ] showed that 11 % patients required laparotomy and mortality was 7 %
though the six studies included in the review were all retrospective, had a total of 46
patients and involved signifi cant variation in patient selection ( timing of intervention, previous interventions and indication for intervention) and operative technique. With the advent of retroperitoneal and endoscopic debridement techniques,
laparoscopic transperitoneal debridement is being used less frequently these days.
Retroperitoneal Necrosectomy
Alverdy et al. described the technique of laparoscopic intracavitary debridement
after percutaneous drain placement in two patients with WON in 2000 for the fi rst
time [ 31 ]. This was followed by a case series of ten patients with confi rmed infected
pancreatic necrosis who underwent retroperitoneal necrosectomy as the primary
modality for debridement [ 32 ]. A median of two explorations was needed with a
median inpatient stay of 42 days. One patient required conversion to open laparotomy due to bleeding from injury to splenic vessels and a total of two patients died
post procedure.
Castellanos et al. [ 33 ] performed translumbar retroperitoneal debridement in 15
patients with mortality of 27 % and complications in 40 % (6/15) patients (one pancreatic fi stula , one duodenal, one colonic perforation, two pseudocysts and one lumbotomy eventeration). Only one patient required pancreatic enzyme and insulin
replacement during follow up. Numerous smaller, retrospective case series have
confi rmed the use of retroperitoneal debridement for infected WON [ 32 , 34 , 35 ].
The major studies that investigated role of retroperitoneal necrosectomy for WON
are listed in Table 40.3 .
Hovarth et al. for the fi rst time reported prospective data of a step up approach in
a multicenter trial involving 40 patients with infected pancreatic necrosis . All
patients initially underwent percutaneous drains and if more than 75 % of necrosis
persistent after 10–14 days, more invasive (VARD or open necrosectomy) were
performed. Thirty-one (77 %) patients had less than 75 % decrease in necrosis and
25 out of these underwent VARD. VARD was successful in 60 % patients while
remaining had conversion to open surgery .
A. Singh and A. Gelrud
457
Table 40.2 Outcomes of laparoscopic transperitoneal debridement for
Author/year N
Infected
necrosis n (%)
Time to surgery after
disease onset (days)
Success
n (%)
Re-intervention
n (%)
Morbidity/
complications, n (%)
Mortality
n (%)
Gagner 1996 [
26 ] 8 NA NA 6 (75) 38 % NA 0
Zhu 2001 [
27 ] 10 0 1–3 7 (70) NA NA 10 %
Zhou 2003 [
28 ] 13 4 (31) NA 12 (92) 0 NA 15 %
Parekh 2006 [
29 ] 19 9 (47) NA 16 (84) 11 % 21 % 11 %
Bucher 2008 [
46 ] 8 8 (100) 31 (13–59) 8 (100) 25 % 0 0
Tan 2012 [
23 ] 25 25 (100) 30 (13–46) NA 4 % 48.3 % 4 %
40 Endoscopic or Minimally Invasive Debridement of Walled-Off Pancreatic Necrosis?
458
Table 40.3 Review of studies of retroperitoneal necrosectomy
Author/year N
Infected
necrosis n
(%)
Time to surgery
after disease
onset (ds)
Success
n (%)
Necrosectomy
Sessions per patient
Need for
laparotomy, n (%)
Morbidity/
complications n (%) Mortality (%)
Gambiez 1998 [
47 ] 20 13 (65) 18 (13–26) 75 % 5 ± 4 NA 60 % 10 %
Carter 2000 [
32 ] 10 10 (100) 40 (13–187) 80 % 2.4 (1–4) 1 (7 %) 28 % 20 %
Castellanos 2002 [
33 ] 15 15 (100) NA 73 % 1 0 40 % 27 %
Connor 2005 [
34 ] 47 38 (41) 28 (3–161) 75 % 3 (1–5) 12 (26 %) 92 % 19 %
Cheung 2005 [
35 ] 8 4 (50) 3–22 weeks 62.5 % NA 3 (37.5 %) 50 % 12.5 %
Horvath 2010 [
48 ] 25 25 (100) 80 (33–208) 60 % 1 (1–2) 10 (40 %) 42 % 4 %
Raraty 2010 [
49 ] 137 88 (64) 32 (1–181) 84 % 3 (1–9) 19 (14 %) 55 % 19 %
Bakker 2012 [
24 ] 10 9 (90) 59 (29–69) 60 % 1 (1–2) 4 (40 %) 80 40 %
Baush 2012 [
50 ] 14 13 (93) 39 (15–184) 57 % NA 3 (21 %) 57 % 21 %
Castellanos 2013 [
36 ] 32 32 (100) 19 (11–28) NA 3 (1–10) NA 9.3 % 15.6 %
Zhao 2014 [
51 ] 17 17 (100 %) 29 (14–45) NA 2 2 (12 %) 9 (53 %) 0
A. Singh and A. Gelrud
459
In a systematic review of nine reports on retroperitoneal necrosectomy [ 30 ], 141
patients were evaluated. There was signifi cant heterogeneity in the technique and
inclusion criteria, but the overall mortality for retroperitoneal debridement was
16 % and 13 % patients required laparotomy. The complication rate was 41 % and
majority of the patients required more than one debridement session. Castellanos
et al. [ 36 ] updated their prospectively collected data of retroperitoneal necrosec-
tomy by describing 32 patients who underwent the procedure for confi rmed infected
pancreatic necrosis . A median of three debridement sessions was performed, with a
reported mortality of 15.6 % and morbidity of 9.3 %. There was clinical complete
resolution of symptoms in 27/32 patients after a median follow up of 84 months. It
is important to note that they did not use the step up approach or percutaneous catheter drainage prior to retroperitoneal debridement. Most of the studies for VARD
have used catheter drainage for lavage of the necrotic cavity for many days though
no consensus on the optimal drainage exists.
Percutaneous Drainage
Percutaneous approach involves placement of percutaneous drains in to the collections under ultrasound or CT guidance followed by frequent fl ushing of the cavity.
The three main advantages of percutaneous drainage are that the drain tract can be
used in future for further necrosectomy (either video assisted or endoscopic ), the
complications and mortality associated with percutaneous drainage are low and percutaneous drainage can be performed in critically ill patients early in the course of
disease when a well defi ned capsule is not present. But since no debridement is done
initially, the success rate is not very high and more invasive interventions are usually
needed, particularly in large cavities or if infection is present). Even though the data
is mainly retrospective and from small sized studies, approximately 44 % patients
can avoid further invasive interventions after percutaneous drainage of pancreatic
necrosis [ 37 ]. In a systematic review, Baal et al. evaluated percutaneous catheter
drainage (PCD) as the primary intervention for management of pancreatic necrosis
[ 38 ]. They found that no additional surgical intervention was needed in 55.7 % of
the patients and mortality in the PCD group was 15.4 %.
Endoscopic Necrosectomy
Over the last decade endoscopic necrosectomy has emerged as the most common
debridement intervention for walled-off necrosis due to improvements in technology, endoscopist expertise and use of carbon dioxide for insuffl ation. Multiple
non- randomized studies have shown the effi cacy of endoscopic transmural
necrosectomy in managing walled-off necrosis. Baron et al. for the fi rst time in
1996 published a case series of 11 patients who had cystgastrostomy and
40 Endoscopic or Minimally Invasive Debridement of Walled-Off Pancreatic Necrosis?
460
nasocystic irrigation for walled off necrosis. Trans-luminal direct endoscopic
necrosectomy was fi rst reported in 2000 [ 39 ]. Since then multiple studies have
shown effi cacy of transgastric access into the retroperitoneum and debridement
of necrotic tissue followed by placement of stents to allow for subsequent drainage [ 24 , 40 , 41 ].
EUS guidance should be used when puncturing the gastric wall if a defi nite
bulge is not seen endoscopically or if gastric varices are present [ 42 ]. EUS also
helps assess the degree of necrotic debris inside the cavity. Once the cavity is
punctured, it is followed by balloon dilatation and placement of plastic or metal
stents. This allows for access to the retroperitoneum for debridement, which can
be done using various tools including forceps, snares, baskets, nets as well as vigorous irrigation. The data about placement of nasocystic drains and use of hydrogen peroxide is still not conclusive. Repeat debridement can be done using the
cystgastrostomy tract.
A multi-center study from the United States involved 104 patients with symptomatic WON who underwent direct endoscopic necrosectomy with successful
resolution in 91 % patients after a mean period of 4.1 months and a median of
three procedures [ 9 ]. Peri-procedural complications occurred in 14/103 patients
and included signifi cant bleeding requiring blood transfusion and 2 deaths. In the
fi rst randomized trial comparing endoscopic transgastric necrosectomy with surgical necrosectomy (ten patients in each group, PENGUIN trial: the Pancreatitis
Endoscopic Transgastric vs Primary Necrosectomy in Patients with Infected
Necrosis), Bakker et al. showed that endoscopic necrosectomy reduced proinfl ammatory response and was associated with markedly decreased incidence of
major complications or death (20 % vs. 80 %) [ 24 ]. The endoscopic approach
involved transgastric puncture, balloon dilation, followed by retroperitoneal
drainage and necrosectomy while surgical approach consisted of video-assisted
retroperitoneal debridement (VARD) or laparoscopic if VARD was not feasible.
Patients who underwent endoscopic transgastric necrosectomy had lower post
procedure IL-6 levels (p = 0.004), lower incidence of new onset multiple organ
failure (0 % vs 50 %; p = 0.03), lesser pancreatic fi stula s (10 % vs 70 %, p = 0.02)
and a non-signifi cant trend towards lower mortality (10 % vs. 40 %; p = 0.3). The
data about long-term outcomes of endoscopic transluminal necrosectomy is still
limited but promising. Seifert et al. showed an 84 % clinical success rate with 26
% complication rate and 7.5 % mortality in 93 patients undergoing endoscopic
necrosectomy after a mean follow-up interval of 43 months. The mean number of
endoscopic procedures required was six and only 4 % patients required surgical
interventions while 16 % had recurrent pancreatitis episodes [ 40 ]. The studies
that reported outcomes for endoscopic debridement of WON are listed in Table
40.4 . It is important to note that most of these studies are non-randomized, retro-
spective, observational studies. The overall success of endoscopic debridement in
these studies ranges from 69 % to 100 % with a mortality of 0–15 %. The number
of debridement sessions reported range from 1.4 to 6 though one study reported
up to 15 debridement sessions.
A. Singh and A. Gelrud
461
Table 40.4 Review of studies with endoscopic debridement
Author/year N
Infected
necrosis n (%)
Time to surgery after
disease onset (days)
Success
n (%)
Necrosectomy
Sessions per
patient
Need for
surgery, n (%)
Morbidity/
complications n (%)
Mortality
n (%)
Seifert 2000 [
39 ] 3 1 (33) 14–64 100 % NA 0 NA 0
Seewald 2005 [
52 ] 13 13 (100 %) NA 77 % 1 (1–4) 4 (31 %) 30 % 0
Charnley 2006 [
53 ] 13 11 (85 %) 27 100 % 4 (1–10) 2 (15 %) NA 15 %
Papachristou 2007 [
41 ] 53 26 (49 %) 49 (20–300) 81 % 3 (1–12) 12 (23 %) 49 % 6 %
Voermans 2007 [
54 ] 25 19 (76 %) 84 (21–385) 93 % 2 (1–4) 2 (8 %) 40 % 0
Hocke 2008 [
55 ] 30 30 (100 %) NA 97 % 2.7 (1–16) 3 (10 %) 10 % 7 %
Escourrou 2008 [
56 ] 13 13 (100 %) 28 (21–32) 100 % 1.8 (1–3) 0 46 % 0 %
Seifert 2009 [
40 ] 93 50 (54 %) 43 84 % 6 14 (15 %) 26 % 8 %
Ross 2010 [
57 ] 15 9 (60 %) 29 (4–207) 100 % 1.4 0 13 % 0 %
Gardner 2011 [
9 ] 104 40 (39 %) 63 91 % 3 (1–14) 1 (1 %) 14 % 2 %
Bakker 2012 [
24 ] 10 19 (100 %) 59 (29–69) 100 % 3 (2–6) 2 (20 %) 20 % 10 %
Smoczynski 2014 [
58 ] 112 NA 16.3 weeks (3–78 weeks) 93 % 2.7 (1–6) 7 (6.25 %) 26 % 1.8 %
40 Endoscopic or Minimally Invasive Debridement of Walled-Off Pancreatic Necrosis?
462
Step-Up Approach
A step-up approach that aims at control of infection source rather than complete
removal of infected necrosis has been proposed. In the PANTER trial ( minimally
invasive step up approach vs. maximal necrosectomy in patients with acute necrotizing pancreatitis), Van Sanvoort et al. randomized patients with necrotizing pancreatitis and confi rmed or suspected infection in the necrosis to either primary open
necrosectomy or a step-up approach [ 13 ]. The step-up approach involved either
percutaneous or endoscopic drainage followed by VARD if no improvement. They
showed that primary end point of death or major complications was seen in 40 %
patients with minimally invasive step up compared to 69 % patients who underwent
primary open necrosectomy (RR = 0.57, 95 % CI 0.38–0.87, p = 0.006). A very
important outcome of the study was that up to 40 % of patients with infected necrosis could be managed by drainage along thus obviating the need for debridement.
The limitations of this study included not using laparoscopic necrosectomy instead
of open necrosectomy in patients undergoing surgery and endoscopic necrosectomy
was not performed in majority of the patients (only 5 % of the patients in the step
up group underwent endoscopic necrosectomy).
More prospective trials comparing percutaneous drainage , VARD, endoscopic
necrosectomy and hybrid techniques (combination of drainage techniques) are
needed. In a recently published retrospective, observational study of 100 patients
with symptomatic walled-off necrosis, Bang et al. [ 43 ] showed that adoption of a
step-up approach for WON based on collection size, location and response to intervention led to improved treatment success compared with the conventional endoscopic management (91 % vs. 60 %, p < 0.001). Management based on step-up
algorithm was the only predictor of treatment success on multivariate logistic
regression analysis (OR 6.51, 95 % CI 2.19–19.37 p = 0.001). But confl icting data
exists as well. Kumar et al. compared step up approach with direct endoscopic
necrosectomy in a recently published matched cohort study (12 patients with
infected WON in each group) [ 44 ]. They showed that direct endoscopic necrosec-
tomy led to higher rates of clinical success (11/12 vs 3/12), decreased need for
surgical intervention, lesser new antibiotics use, respiratory failure, endocrine insuffi ciency, shorter length of stay and lower health care utilization. To compare the
outcomes between endoscopic step up and surgical step up approaches, the results
of ongoing randomized controlled, superiority multicenter trial from the Netherlands
(the TENSION trial) will be important [
45 ].
Conclusion/Recommendations
• Open surgical debridement of walled-off necrosis is associated with higher mor-
bidity and mortality compared to minimally invasive necrosectomy approaches
and should be avoided unless absolutely necessary (evidence quality high; strong
recommendation)
A. Singh and A. Gelrud
463
• Step-up approach starting with percutaneous drainage and followed by
endoscopic or retroperitoneal debridement if percutaneous drainage fails should
be adopted (evidence quality high; strong recommendation)
• If accessible endoscopically, endoscopic debridement should be preferred over
retroperitoneal debridement (evidence quality moderate; weak
recommendation)
A Personal View of the Data
Multi disciplinary approach is imperative. Debridement should be avoided in the
early stages of necrotizing pancreatitis if possible. Around 15–20 % of WON with
infection can be managed conservatively with antibiotics, though very close monitoring for any change in clinical status is very important. If absolutely necessary,
percutaneous catheter drainage should be used in early stages, in 20–25 % of
patients this approach will be curative. If no improvement despite antibiotics and
catheter drainage, minimally invasive debridement should be considered. The
choice is determined by local expertise and location of the WON. For endoscopically accessible WON collections, transmural approach should be preferred. It is
associated with decreased systemic infl ammatory response and is also without
external fi stulae or drains and still allows repeat debridement sessions to be performed. VARD should be considered if no improvement despite endoscopic necrosectomy and percutaneous drainage or if the collection is not accessible
endoscopically or to large. Laparoscopic transperitoneal debridement followed by
open necrosectomy should be reserved if none of the above interventions lead to
clinical improvement or if the necrosis is extensive and cannot be fully debrided by
endoscopic or retroperitoneal approaches.
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40 Endoscopic or Minimally Invasive Debridement of Walled-Off Pancreatic Necrosis?