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Management ofInfected Necrosis: Step- Up Approach

Downloaded from https://onlinelibrary.wiley.com/doi/ by Universität Bern, Wiley Online Library on [22/08/2023]. See the Terms and Conditions (https://onlinelibrary.wiley.com/terms-and-conditions) on Wiley Online Library for rules of use; OA articles are governed by the applicable Creative Commons License

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28 Horvath K, Freeny P, Escallon J etal. Safety and efficacy of

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29 van Baal MC, van Santvoort HC, Bollen TL etal.

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30 Boxhoorn L, van Dijk SM, van Grinsven J etal. Immediate

versus postponed intervention for infected necrotizing pancreatitis. N Engl J Med 2021;385(15):1372–1381.

31 Tenner S, Baillie J, DeWitt J, Vege SS; American College of

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32 Villatoro E, Mulla M, Larvin M. Antibiotic therapy for

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34 van Brunschot S, van Grinsven J, van Santvoort HC etal.

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35 Park DH, Lee SS, Moon S- H etal. Endoscopic ultrasound-

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37 Varadarajulu S, Phadnis MA, Christein JD, Wilcox CM.

Multiple transluminal gateway technique for EUSdrainage of symptomatic walled-

off pancreatic necrosis.

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38 Varadarajulu S, Bang JY, Phadnis MA, Christein JD,

Wilcox CM. Endoscopic transmural drainage of peripancreatic fluid collections: outcomes and predictors of treatment success in 211 consecutive patients. JGastrointest Surg 2011;15(11):2080–2088.

39 Varadarajulu S, Tamhane A, Blakely J. Graded dilation

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41 Bang JY, Hasan M, Navaneethan U, Hawes R, Varadarajulu

S. Lumen-

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42 Boxhoorn L, Verdonk RC, Besselink MG et al. Comparison

of lumen-apposing metal stents versus double-pigtail plastic stents for infected necrotising pancreatitis. Gut2022;72(1):66–72.

43 Arvanitakis M, Dumonceau J- M, Albert J etal. Endoscopic

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Minimally invasive and endoscopic versus open necrosectomy for necrotising pancreatitis: a pooled analysis of individual data for 1980 patients. Gut 2018;67(4):697–706.

47 Seewald S, Groth S, Omar S etal. Aggressive endoscopic

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Management ofInfected Pancreatic Necroses: An Endoscopic Approach

Todd H. Baron

Division of Gastroenterology and Hepatology, University of North Carolina, Chapel Hill, NC, USA

Pancreatic Necrosis

Pancreatic fluid collections (PFC) can occur as a complication of acute pancreatic injury (acute pancreatitis, trauma, surgical resection or injury to the pancreas during abdominal surgery) or chronic injury (chronic pancreatitis, autoimmune pancreatitis). At the basis of this pancreatic injury is disruption of the main pancreatic duct and/or side branches. Acute necrotizing pancreatitis (ANP) is at the severe end of a spectrum of inflammation associated with pancreatitis, resulting in cell death. Pancreatic necrosis is defined as nonviable pancreatic parenchyma usually with associated peripancreatic fat necrosis and occurs in 20–30% of all episodes of pancreatitis[1]. The resultant devitalized tissue becomes a potential bed for infection. Approximately 30% of patients with pancreatic necrosis develop infection of the necrotic tissue[2]. The amount of necrotic tissue is the strongest predictor of mortality necrotic pancreatitis. Fortunately, with early recognition and improvements in critical care most patients survive the early phase of systemic inflammatory response syndrome (SIRS) and many survive multisystem organ failure. Even with aggressive intravenous fluid replacement, nutritional support, and early intervention of pancreatic necrosis, the presence of pancreatic necrosis is associated with an overall increase in mortality as compared to interstitial or edematous pancreatitis. The mortality rate from sterile pancreatic necrosis is approximately 13% and rises to 35% when infected[2].

ANP is detected radiographically on contrastenhanced CT (CECT) by the presence of non- enhancing pancreatic parenchyma. In the first few weeks after onset of ANP, pancreatic necrosis and/or peripancreatic fat necrosis can evolve into more organized processes that expand the initial area of necrosis. If this

process occurs prior to 4weeks after the onset of ANP it is termed an acute necrotic collection, which is potentially amenable to endoscopic drainage. After 4weeks from onset of ANP such collections are termed walledoff pancreatic necrosis[3]. Both of these processes contain variable amounts of fluid (pancreatic juice) and solid debris (pancreatic and/or peripancreatic fat necrosis). Infected necrosis refers to bacterial invasion of necrotic pancreatic tissue and can lead to clinical infection, sepsis, and death. Infected necrosis is rare during the first week after onset of ANP[4,5]. Evidence suggests no absolute correlation between the extent of necrosis and the risk of infection and duration of symptoms. The mortality rate is substantially increased when infection occurs and most patients will require intervention and drainage.

Mechanical Intervention

Mechanical intervention for infected pancreatic necrosis can be surgical, percutaneous, and endoscopic. Open surgical therapy is not considered as firstapproach[6] and has largely been replaced by minimally invasive approaches[7,8] using flexible endoscopic, rigid endoscopic (via percutaneous catheter sites)[9], percutaneous drain placement, and laparoscopic approaches, alone or in combination [5]. It has been more than 25years since the first report of endoscopic drainage for pancreatic necrosis [10]. Optimal management of necrotizing pancreatitis requires a multidisciplinary team including dedicated surgeons, interventional radiologists, and gastrointestinal endoscopists. Such a multidisciplinary team needs to be involved from the onset of the disease to decide if, when, and how an intervention needs to be performed.

line

The Pancreas: An Integrated Textbook of Basic Science, Medicine, and Surgery, Fourth Edition. Edited by Hans G. Beger, Markus W. Büchler, RalphH. Hruban, Julia Mayerle, John P. Neoptolemos, Tooru Shimosegawa, Andrew L. Warshaw, David C. Whitcomb, and Yupei Zhao. © 2023 John Wiley & Sons Ltd. Published 2023 by John Wiley & Sons Ltd. Companion website: www.wiley.com/go/beger/thepancreas4e

Transmural Drainage 261

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Intervention in asymptomatic or minimally symptomatic patients with sterile necrosis is not indicated regardless of size, location, and extension [11,12]. For patients with sterile WOPN and persistent gastric outlet, intestinal, or biliary obstruction due to mass effect, intervention may be undertaken at least 4weeks after onset of symptoms, the timing dependent on severity. In patients with persistent symptoms such as pain and “failure to thrive” the form and timing of intervention is debated and current intervention can be considered 8weeks after onset[12].

In clinically stable patients with infected necrosis, it is advisable to continue supportive care with antibiotic therapy directed empirically or by culture data and delay surgical, radiologic, or endoscopic approaches for more than 4 weeks in order to facilitate the formation of WOPN with liquefaction of the contents. Indeed, in a recent landmark randomized trial of patients with infected necrosis, there was a significant improvement in outcome when endoscopic intervention was delayed until patients developed WOPN[1]. Prompt drainage is required for patients with infected necrosis and clinical instability. In these cases, minimally invasive methods of drainage are preferred. Distinguishing sterile from infected necrosis can be difficult but is important as the presence of infection alters prognosis and management. Percutaneous fine- needle aspiration (FNA) of pancreatic and peripancreatic collections for the detection of infection should not be routinely performed. It may postpone interventions, give false negative results or induce secondary infection [5]. Suspicion of infection is usually based on clinical deterioration despite medical support, high fever with rising inflammatory markers and/or positive blood cultures. The presence of gas on imaging studies is highly suggestive of infection, likely due to fistula, but it is only present in a minority of cases[13,14]. Infection can be confirmed by FNA or through cultures obtained at the time of drainage, and can be used to guide antibiotic therapy[11].

The goals of endoscopic therapy for infected WON are: (i) drainage of fluid and removal of solid components using a transmural approach (transgastric or transduodenal), and (ii) treatment of pancreatic ductal (PD) leaks and/or disruptions using a transpapillary approach, in selected patients. Theoretically, addressing pancreatic disruptions may lead to better long-

term outcomes[15]. However, despite the relatively high incidence of ductal disruptions in patients with WOPN, subsequent disconnected duct syndrome following endoscopic therapy is uncommon[16]. Transpapillary endoscopic drainage as primary therapy of WOPN is not an adequate method to remove solid debris. Removal of solid debris is vital to any type of intervention during transmural drainage, which can be “mechanical,” by irrigation, or a combination.

In case of proven or suspected infected necrotizing pancreatitis, intervention should be delayed when possible until ≥4 weeks after onset of ANP [17,18]. Endoscopic transmural access can be undertaken for acute necrotic collections as early as 2–3weeks after the onset of acute pancreatitis in the setting of sepsis as long as they are deemed to be organized as determined by CT or MRI[19–21].

Transmural Drainage

The evolution of endoscopic therapy of WOPN began as with pseudocyst drainage using small diameter transmural tracts (8 mm) and placement of 10Fr plastic stents, in addition to a nasocystic irrigation tube[10]. Early in the endoscopic experience many patients required adjunctive percutaneous drains, especially to treat large paracolic gutter extensions[22]. Larger diameter transmural dilations were then added to the irrigation approach. Nasocystic irrigation tubes can be used for continuous flushing with sterile fluid per 24 hours or by bolus lavage every 3–4 hours for several days to weeks depending on the volume of debris and patient tolerance and may avoid the need for subsequent necrosectomy. However, they are uncomfortable, and with the advent of largetransluminal metal stents, their use is decreasing.

Direct endoscopic necrosectomy (DEN) was introduced by Siefert[23], and subsequently Seewald[24] as a method to remove necrotic tissue by passing forward or sideviewing endoscopes transmurally into the collection; baskets, grasping forceps, and snares are used to remove solid debris[25]. Transmural placement of large diameter covered (esophageal) SEMS or large diameter (15–20 mm) self- expandable lumen- apposing metal stents (LAMS) can not only avoid the need for additional endoscopic intervention by allowing egress of fluid and debris, but also facilitate passage of endoscopes into the necrotic cavity to perform direct necrosectomy while preventing the need for repeated balloon dilation of the gastric or duodenal wall to enter the cavity. Indeed, in most Western countries a commercially available LAMS that has an electrocautery tip and which is specifically designed for use with endoscopic ultrasound (EUS) scopes has greatly simplified the technical aspects of the procedure [26]. Instillation of hydrogen peroxide into the necrotic cavity may facilitate removal of necrotic debris during DEN and reduce the likelihood of further necrosectomies[27].

In conjunction with percutaneous drain placement, hybrid approaches have also been described [28]. In some patients with peripheral collections that are not accessible from a transluminal approach, a percutaneous drain is placed. Subsequently, a large- bore selfexpandable metal stent is placed through the

diameter

Management ofInfected Pancreatic Necroses: An Endoscopic Approach

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262

percutaneous tract to allow for direct endoscopic necrosectomy with a flexible endoscope.

A dual- modality drainage technique using CT- guided percutaneous irrigation/drainage catheter placement is followed directly by endoscopic transmural drainage. The percutaneous catheter is used for irrigation, with egress internally through the transmural tracts. This allows avoidance of direct endoscopic necrosectomy. Using this approach with endoscopically placed plastic stents resulted in decreased length of hospitalization and number of radiological and endoscopic procedures compared with either modality alone [29]. This approach also hastened resolution, but also prevented development of external fistulae and bleeding related to percutaneous manipulations. Surprisingly, the introduction of LAMS did not appear to offer an advantage to plastic stents at the same institution[30].

For complex organized necrosis, a multi-

gateway approach[31] has been described, which utilizes two or more transmural entry approaches to permit irrigation and improved drainage. Nasocystic irrigation enters one site and egresses from another.

Transmural Entry Devices

Devices used to perform transmural puncture of WOPN can be divided into cautery and non- cautery devices. Cautery devices include standard diathermy wires (needle knives), specialized fistulotomy devices (Cystotome CST- 10; Cook Endoscopy, Winston- Salem, NC, USA) and specialized stent delivery systems with cautery incorporated (AXIOS- EC; Boston Scientific, Marlborough, MA, USA). Non- cautery devices include 19- gauge EUS- FNA needles.

The collection is punctured transmurally using EUS guidance to be certain of the puncture site and to avoid vessels using Doppler. Fluid is aspirated during the procedure and sent for microbial analysis including Gram stain and culture. The procedure can be performed with or without fluoroscopy.

length (10 or 15

mm) LAMS (AXIOS; Boston Scientific) with luminal diameters of 15–20 mm and electrocautery incorporated delivery systems are now commonly used due to ease of placement [32]. With commercially available electrocautery- equipped LAMS delivery systems the stent is placed in a single- step (puncture and stent deployment). One needs to be particularly careful of proper device deployment, particularly the final, crucial step involving proximal flange release. Some endoscopists prefer to place a plastic double- pigtail stent through the LAMS to prevent occlusion due to impaction of necrotic material and contact of the stent edge against the inner wall of the cavity.

Direct endoscopic necrosectomy (DEN) can be performed using a standard forward- viewing endoscope during the initial endoscopic procedure after balloon dilation of the tract (12–20 mm) or the LAMS lumen (Fig.29.1) to its maximal diameter although placement of the LAMS alone may be adequate to resolve WOPN (Fig.29.2). In one study, LAMS alone allowed complete resolution of WOPN without necrosectomy in approximately half of 136 patients [33]. Patients with collections ≥10

cm in size, paracolic extension, or ≥30% solid debris within the collection were more likely to require additional intervention. Some authors advocate scheduled endoscopic debridements at intervals ranging from days to weeks depending upon inpatient or outpatient status, severity of illness, anticipated volume of residual necrosis, and findings on follow- up CT or MRI. Internal drains are endoscopically removed several weeks after complete resolution of the collection and after removal of external drains (if placed) to prevent persistent pancreatico- cutaneous fistula. Patients

Stent Placement

Antithrombotic agents should be discontinued whenever possible prior to transmural drainage, and certainly prior to direct endoscopic necrosectomy. In case of severe bleeding during the procedure which cannot be treated endoscopically, immediate assistance of an interventional radiologist should be requested. Endoscopic drainage and necrosectomy are preferably performed with patients under deep sedation or general anesthesia. Plastic stents are not ideally suited to drain WOPN because of their small diameter. The use of large- diameter fully covered self- expandable metal stents are used instead. Specially designed biflanged short

Figure29.1 Image after direct endoscopic necrosectomy through

a LAMS. The LAMS was removed at the end of the procedure as seen alongside a portion of the necrotic debris removed during the procedure.

(a) (b)

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Adverse Events ofEndoscopic Therapy ofPancreatic Necrosis 263

Figure29.2 Endoscopic resolution of WOPN using a 20 mm luminal apposing metal stent. (a) Coronal CT image showing classic WOPN;

(b) coronal CT after resolution with LAMS in place and plastic double- pigtail stent within it.

with infected necrosis continue antibiotic therapy, either empirically or based upon culture data obtained during drainage and/or debridement. All procedures should be performed with carbon dioxide (CO2) insufflation since fatal gas embolism has been described.

Tools for performing DEN include standard snares, baskets, large caliber grasping forceps, and retrieval nets. Recently, an endoscopic morcellator has become available to enhance removal of necrotic tissue[34].

radiology support. The most feared adverse events of transmural drainage are bleeding and perforation. Bleeding after transmural drainage may be managed supportively, endoscopically, surgically, or with angiographic embolization. If perforation occurs during attempted transgastric drainage and is limited to the gastric wall (does not involve the collection), it may be successfully managed nonsurgically if a stent is not mistakenly placed through the perforation and outside the gastric wall. If egress of gastric contents is prevented, the gastric wall rapidly closes with conservative treat-

Results ofEndoscopic Therapy ofPancreatic Necrosis

ment consisting of nasogastric suction and antibiotics. If plastic stents were used during initial placement, large-

diameter covered SEMS can be used to close perforation There are many series showing that endoscopic treatment of WOPN is successful in achieving nonsurgical resolution in the majority of patients with central pancreatic necrosis[18,35]. The outcomes appear to be improving with the use of large- diameter metal stents with clinical resolution of WOPN occurring in 90%[26,36,37].

at the transmural site and tamponade bleeding. Infectious

adverse events usually occur from inadequate drainage

of fluid and/or solid debris. Stent migration into the col-

lection through the gastric or duodenal wall may occur

during or after endoscopic stent placement. Endoscopic

retrieval is possible if the collection has not completely

collapsed and the transmural tract is still patent. Fatal air

embolism has been reported following DEN [38]. This

Adverse Events ofEndoscopic Therapy ofPancreatic Necrosis

has prompted the use of CO

rather than air insufflation

during drainage and necrosectomy.

Endoscopic therapy may be associated with adverse Life- threatening adverse events may arise following attempted endoscopic drainage of pancreatic necrosis. It is recommended that endoscopic drainage be performed with the availability of surgical and interventional

events and/or failures that require surgical management. It is possible that the outcome of surgical therapy may be adversely altered when compared to those patients undergoing primary surgical therapy.

Management ofInfected Pancreatic Necroses: An Endoscopic Approach

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What is clear is that if endoscopic therapy is undert aken, commitment is required by the endoscopist, clinical care team, and most importantly the patient. Endoscopic debridement is a time- consuming, labor- intensive process not for the uncommitted [39] or the faint of heart since adverse events occur more

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266

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Minimally Invasive Debridement andLavage ofNecrotizing Pancreatitis

Kulbir Mann and Michael G.T. Raraty

Liverpool University Hospitals NHS Foundation Trust, Royal Liverpool University Hospital, Liverpool, UK

Introduction

The prevalence of acute pancreatitis has increased over the decades according to the Global Burden of Disease Study in 2017. Prevalence has increased from 3,038,787in 1990 to 6,115,833in 2017with an age standardized prevalence rate of 67.2in 1990 to 76.2 per 100,000in 2017[1]. This is an increase of 13.3% and given that approximately 20–30% of patients develop moderate to severe pancreatitis, there is a significant impact on survival and burden on health resources[2]. The revised Atlanta criteria classifies acute pancreatitis into stages based on organ failure and local complications. If organ failure exists for more than 48 hours then the patient has severe pancreatitis. It is this set of patients that will need intervention as acute necrotic and peripancreatic fluid collections develop into walled- off necrosis or pseudocysts [3]. Necrotizing pancreatitis consists of necrosis of peripancreatic tissue and of the pancreatic parenchyma and comprises 5–10% of all cases[4]. The pathological process leads to maturing collections that afford the opportunity of specifically targeted intervention in a minimally invasive manner. This chapter will focus on three minimally invasive techniques: minimal access retroperitoneal pancreatic necrosectomy (MARPN), single port retroperitoneal pancreatic necrosectomy (SPRPN), and laparoscopic approaches to necrosectomy.

Minimal Access Retroperitoneal Pancreatic Necrosectomy

The original technique published from Liverpool in 2003gained access to the necrotic cavity using a percutaneous drain placed under CT guidance[5,6]. The optimal retroperitoneal path is on the patient’s left flank, inferior

to the spleen, superior to the kidney and posterior to the splenic flexure, Figs30.1 and30.2. This drain can be used alone to evacuate liquefied necrosis and can be used as a single strategy in 9% of patients, in modern step- up approach strategies, and even higher in other reported cohort studies[7,8]. The first ever attempt to perform a MARPN was under sedation, in the operating room in a patient who was unable to tolerate a general anesthetic. This strategy is still possible but it is preferred to give the patient anesthesia and muscle relaxant. Patients are placed on the operating table in a supine position with the patient tilted allowing the drain tract to be as horizontal as possible. They are placed at the edge of the table with a sandbag placed under the left- hand side of the patient for additional positioning. The surgeon can either sit at the patient’s left or stand and vary the table height. Under fluoroscopic guidance a guidewire is placed through the pigtail drain, ensuring it passes through into the cavity with enough length to allow the drain to be removed. After making a 1 cm skin incision, a renal dilator set is used to dilate the track following the guidewire, ensuring not to pass further than necessary. Once the dilatation is complete, a 24Fr Amplatz sheath is inserted over the guidewire and fixes the position of the track, and frequently a significant amount of pus and liquid debris drains. A nephroscope with a wide- bore operating channel is then passed through the sheath and warm saline irrigation commences. This allows direct visualization of the necrotic cavity and piecemeal evacuation using laparoscopic grasping forceps, Fig.30.3. The initial procedure does not afford significant necrosectomy as the debris is adherent to granulating cavity walls, and removal can lead to significant bleeding. At the end of the procedure the wire is replaced through the sheath and then an irrigation device is placed into the cavity, over the wire at a pre- measured distance to ensure it is not placed too

Spleen

(a) (b)

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Colon

Figure30.1 Preferred retroperitoneal approach to infected

pancreatic necrosis, avoiding the spleen, left kidney, and colon. Source: Raraty etal. Trattamento miniinvasivo della pancreatite acuta necrotizzante. In: Pedrazzoli S, ed. Neuro Trattato di Tecnica Chirurgica Pancreas: Peritoneo, Retroperitoneo, Surrene, Milza. Milan: UTET, 2006.

Kidney

Acute Complications 267

next few weeks whilst the NG tube is slowly pulled back. A median of three procedures has been reported to completely clear the necrotic cavity[5].

A similar technique using video- assisted debridement was described in 2001where the patient is placed in a similar position to MARPN [9]. A 4–5 cm incision is made below the costal margin at the mid- axillary line close to the percutaneous drain. Blunt dissection is performed through the muscle layers of the abdomen to locate the percutaneous drain and enter the cavity. A laparoscope is inserted into this cavity and a parallel laparoscopic grasper or suction device to perform the necrosectomy under direct vision. Once the necrosectomy is performed two large- bore drains are placed, deep and superficial with an irrigation catheter. The fascia is closed to perform closed irrigation and the skin can be closed or left open. This technique has been part of regular practice in many centers and employed in step- up trials for the management of necrotizing pancreatitis[10].

medially. The irrigation device consists of a 28Fr chest drain with a 10/12Fr irrigation nasogastric tube sutured to it, Fig.30.4. The cavity is irrigated with 0.9% saline at 125 ml/h and after 1–2 weeks, the necrosis is easier to remove with clearly demarcated cavity walls, allowing a larger necrosectomy. Once the cavity appears clear and granulating, the MARPN procedure can cease and a CT scan is performed to check for cavity resolution. The irrigation rate can slowly be reduced and eventually the drain replaced with a single NG, sutured in place, which can be flushed if required. The patient can then be discharged and the cavity will slowly granulate and close over the

Acute Complications

Intervention for necrotizing pancreatitis brings with it a further set of complications adding to an already significant pancreatitis burden. There is commonly a physiological systemic inflammatory response as a contained infected collection is released systemically and patients can become septic. In MARPN patients, this has been reported at 12% with multiorgan failure and with 41% of patients requiring an ITU admission. MARPN remains

Figure30.2 (a, b) Radiological access to the necrotic cavity via the left flank. Tilting the patient with left side up facilitates access to the

necrotic cavity.

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