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Endoscopic Treatment ofAcute Biliary Pancreatitis

Ichiro Yasuda1, Tsuyoshi Mukai2, and Toru Ito

Third Department of Internal Medicine, University of Toyama, Toyama, Japan

Department of Gastroenterological Endoscopy, Kanazawa Medical University, Ishikawa, Japan

Pathogenesis ofAcute Biliary Pancreatitis

Acute biliary pancreatitis (ABP) is caused by pancreatic duct obstruction mainly due to bile duct stones. Once a bile duct stone is impacted at the common channel or distal end of the bile duct, pancreatic duct outflow is obstructed directly or by the compression of the pancreatobiliary septum. Previous reports showed that bile duct stone impaction was found in 26–72% of patients who had ABP when surgery was performed soon after the attack[1]. Spontaneous passage of bile duct stones into the duodenum has been described in up to 50% of ABP cases [2,3]. Sphincter of Oddi spasm might be another cause of ABP. Therefore, the diagnosis of ABP is not always easy at the time of diagnosis of pancreatitis.

Biliary pancreatitis, as well as alcoholic pancreatitis, is a major etiology of acute pancreatitis. ABP accounts for 20–71.4% of cases of acute pancreatitis, but the rate varies across countries. Biliary pancreatitis is more common than alcoholic pancreatitis in Greece, Italy, the United Kingdom, Sweden, and the United States of America, whereas alcoholic pancreatitis is the most major cause in Hungary, France, Taiwan, Korea, and Japan[4–9].

patients with acute pancreatitis. Abdominal computed tomography (CT) is also relatively convenient and has high sensitivity in detecting calcified stones (Fig.32.1), but its sensitivity to detect small stones lacking calcification is limited. Endoscopic retrograde cholangiopancreatography (ERCP) may be indicated in highly suspected cases such as those with bile duct dilation and/or cholangitis. However, magnetic resonance imaging (MRI) or endoscopic ultrasonography (EUS) is recommended to be performed before ERCP in such cases because they are safer and more convenient. Magnetic resonance cholangiopancreatography (MRCP) can provide an image similar to ERCP. It has high sensitivity and specificity in detecting common bile duct stones (more than 90%) [10], but its sensitivity decreases in cases with dilated bile duct and small stones[11]. EUS is recognized as the most reliable imaging modality in detecting bile duct stones [12], has fewer complications, and shows higher sensitivity in detecting small bile duct stones than ERCP[13].

Indication ofEndoscopic Treatment

Diagnosis

In addition to the increased levels of serum pancreatic enzymes, such as amylase and lipase, increased levels of hepatobiliary enzymes and bilirubin suggest the possibility of ABP. In such cases, imaging tests are strongly recommended for diagnosis. Although transabdominal ultrasound is the most convenient imaging modality, the extrahepatic bile duct is often difficult to visualize clearly due to the retention of gastrointestinal gas, especially in

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

Endoscopic treatments are indicated for patients with a bile duct stone confirmed on imaging tests or highly suspected from clinical or laboratory findings. In addition, patients with persistent or repeated increasing levels of biliary and pancreatic enzymes are also indicated even if the presence of biliary stone was unclear. In such cases, a dysfunction in the sphincter of Oddi might be a cause of biliary pancreatitis.

The timing of endoscopic treatments is discussed later, but urgent ERCP should be considered when there is evidence of cholangitis and/or ongoing biliary

Outcomes andTiming ofEndoscopic Interventions 279

(a) (b)

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Figure32.1 Computed tomography image of an impacted stone at the duodenal papilla. White arrow indicates an impacted stone. Axial

image (a) and multiplaner reconstruction image (b).

obstruction. However, conservative treatments such as fasting, rehydration, and administration of antibiotics should be attempted first in patients with mild clinical symptoms and with mild abnormal laboratory data.

Several previous studies have suggested the utility of EUS in narrowing down eligible patients by showing that a preceding EUS avoided unnecessary ERCP in 71.2–

75.4% of patients without increasing the risk of adverse events[13–16].

Techniques

The best way to treat biliary pancreatitis is the removal of the bile duct stone. Endoscopic sphincterotomy is generally performed for this. ERCP is initially attempted to confirm the stone in the bile duct, and endoscopic sphincterotomy is then performed using a sphincterotome if a stone is detected on cholangiogram. Subsequently, endoscopic stone extraction is performed using a retrieval basket or balloon. If the stone is impacted at the papilla, precut papillotomy using a needle knife would be preferred to conventional endoscopic sphincterotomy owing to the difficulty in cannulation into the bile duct in such cases (Fig.32.2).

Endoscopic sphincterotomy with subsequent stone extraction is currently a well- established technique with a high success rate (approximately 90%) [17]. However, procedure- related adverse events, including pancreatitis,

hemorrhage, perforation, and cholangitis, can occur in approximately 10% of the cases[18]. Aggravation of pancreatitis is a particularly considerable concern in patients with pancreatitis. Therefore, cannulation and contrast medium injection into the pancreatic duct should be avoided as much as possible; however, there is no evidence that accidental cannulation into the pancreatic duct affects the clinical course or outcome adversely. Recently, the efficacy of pancreatic duct stenting was suggested in ABP following endoscopic sphincterotomy. In a nonrandomized study, complications were less frequent in the pancreatic duct stent group than in the control group without pancreatic duct stent (9.86% vs. 31.43%, P < 0.002) [19]. However, so far, there is no significant evidence to recommend pancreatic duct stenting after endoscopic treatment for ABP.

Outcomes andTiming ofEndoscopic Interventions

Endoscopic treatments for ABP were initially described in 1981[20,21]. Since then, a number of prospective randomized controlled trials (RCTs) have compared early endoscopic treatments with conservative therapy for ABP. However, as several clinical trials and meta- analyses have provided conflicting evidence, the role and timing of endoscopic intervention in ABP remain controversial.

Endoscopic Treatment ofAcute Biliary Pancreatitis

(a) (b)

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280

Figure32.2 Endoscopic view of an impacted stone at the duodenal papilla. A stone is impacting at the biliary orifice (a). Needle knife

papillotomy is preferably performed in such a case. Whitish pus is discharged after cutting up the papilla from the orifice using a needle knife (b).

Two early RCTs showed lower complication rates, shorter hospital stays, and lower mortality rate in the urgent ERCP group than in the conservative group [22,23]. However, another RCT showed that the overall rate of complications was similar in the two groups, and patients in the early ERCP group had more severe complications[24]. The first meta- analysis published in 1999 showed a high success rate of ERCP (92%) and concluded that early ERCP significantly reduced morbidity (25.0% vs. 38.2%, P < 0.001) and mort ality (5.2% vs. 9.1%, P < 0.05) in ABP[25]. However, later studies suggested that early endoscopic intervention was beneficial in further limited patients.

Several studies have concluded that urgent endoscopic intervention should be considered only in patients with severe biliary pancreatitis[26–28]. In a meta-

analysis by Ayub etal.[27], early endoscopic intervention was associated with significant reduction in complications only in predicted severe biliary pancreatitis (odds ratio [OR]

0.27, 95% confidence interval [CI] 0.14 to 0.53), whereas reduction of mortality was not significant in both predicted mild and severe biliary pancreatitis. Later, a metaanalysis by Moretti et al. [28] also reported that a significant difference in the pooled rate for complications was found only in predicted severe pancreatitis (38.5%, 95% CI −53% to −23.9%, P < 0.0001).

Meanwhile, several other studies have suggested that

the benefit of urgent endoscopic intervention was

expected only in cases with cholangitis or cholestasis [29–34]. Petrov et al. [29] reviewed RCTs on early endoscopic intervention versus conservative management in patients with ABP without acute cholangitis. They found that early endoscopic intervention in patients with predicted mild and predicted severe biliary pancreatitis did not lead to a significant reduction in the risk of overall complications and mortality. Later, Van Santvoort etal.[35] conducted a prospective, observational multicenter study including patients with predicted severe ABP without cholangitis. They analyzed the outcomes in patients without and with cholestasis separately and noted that endoscopic intervention was associated with fewer complications as compared with conservative treatment in patients with cholestasis (25% vs. 54%, P = 0.020), whereas it was not associated with reduced complications (45% vs. 41%, P = 0.814) in patients without cholestasis. A Cochrane review by Tse and Yuan[32] in 2012 showed no evidence that early routine ERCP significantly affected mortality or local/systemic complications of pancreatitis, regardless of predicted severity. However, among trials that included patients with cholangitis, the early routine ERCP strategy significantly reduced mortality and local and systemic complications. In addition, among trials that included patients with biliary obstruction, early routine ERCP strategy was associated with a significant reduction in local and systemic complications. Finally, they concluded that early

References 281

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ERCP should be considered only in patients with coexisting cholangitis or biliary obstruction. A systematic review[36] including 8meta- analyses and 12 guidelines documents a consensus among them regarding indication for early endoscopic intervention is indicated only in ABP patients with coexisting cholangitis and/or persistent cholestasis. In addition, most recently, Schepers et al. [37] assessed urgent ERCP with sphincterotomy versus conservative treatment in predicted severe acute biliary pancreatitis without cholangitis in a multicenter RCT. They recorded no relevant differences in a composite of mortality or major complications (new- onset persistent organ failure, cholangitis, bacteremia, pneumonia, pancreatic necrosis, or pancreatic insufficiency) within 6 months between the groups (38% vs. 44%, P = 0.37).

In summary, urgent ERCP is not necessary in mild acute biliary pancreatitis. Moreover, it can also be avoided even in severe acute biliary pancreatitis when cholangitis or persistent cholestasis is not coexistent.

Cholecystectomy After Endoscopic Treatment

Recurrence rates of ABP of up to 61% have been reported in the absence of definitive treatment[38,39]. Therefore, subsequent cholecystectomy after endoscopic treatment of bile duct stones has been recommended to prevent

recurrent attacks of ABP [40,41], although 25–50% of patients do not undergo cholecystectomy for various reasons [42–44]. The Dutch Pancreatitis Study Group assessed the timing of cholecystectomy after mild biliary pancreatitis in a systematic review including 8 cohort studies and 1 RCT (998 patients). In this cohort, cholecystectomy was performed during index admission in 48% of the cases and interval cholecystectomy was performed in 52% of the cases after a median duration of 40days (interquartile range: 19–58days). Before interval cholecystectomy, 18% of the patients were readmitted for recurrent biliary events such as pancreatitis, cholecystitis, and biliary colics. Therefore, cholecystectomy during index admission for mild biliary pancreatitis appeared safe[45]. Conversely, in cases of severe ABP, the current consensus is to postpone cholecystectomy until after resolution of local or systemic complications[39–41,46]. Most recently, the Dutch Pancreatitis Study Group assessed the optiomal timing of cholecystectomy after severe ABP (necrotizing biliary pancreatitis) in a post hoc analysis of a multicenter prospective cohort. It was found that the risk of overall recurrent biliary events prior to cholecystectomy was significantly lower up to 10weeks after discharge (risk ratio [RR] 0.49, 95% CI 0.27 to 0.90, P = 0.02). The risk of recurrent pancreatitis before cholecystectomy was significantly lower up to 8 weeks after discharge. Therefore, they concluded that the optimal timing of cholecystectomy was within 8weeks after discharge (RR 0.14, 95% CI 0.02 to 1.0, P = 0.02).

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and ERCP in the investigation with suspected biliary obstruction caused by choledocholithiasis: a randomized study. Gastrointest Endosc 2008;67:660–668.

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ultrasonography versus endoscopic retrograde cholangiopancreatography in acute biliary pancreatitis: a systematic review. Eur J Gastroenterol Hepatol 2011;23:367–374.

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management of difficult bile duct stones. Dig Endosc 2013;25:376–385.

18 Freeman ML, Nelson DB, Sherman S etal. Complications

of endoscopic biliary sphincterotomy. N Engl J Med 1996;335:909–918.

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sphincterotomy with or without small-

caliber pancreatic stent insertion in patients with acute biliary pancreatitis: better overall outcome with adequate pancreatic drainage. Scand J Gastroenterol 2012;47:729–736.

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management of gallstone pancreatitis. Endoscopy 1981;13:25–26.

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duodenoscopic sphincterotomy for acute gallstone pancreatitis. Surgery 1981;89:424–428.

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Controlled trial of urgent endoscopic retrograde cholangiopancreatography and endoscopic sphincterotomy versus conservative treatment for acute pancreatitis due to gallstones. Lancet 1988;2:979–983.

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biliary pancreatitis by endoscopic papillotomy. N Engl J Med 1993;328:228–232.

24 Folsch UR, Nitsche R, Ludtke R etal. Early ERCP and

papillotomy compared with conservative treatment for acute biliary pancreatitis. The German Study Group onAcute Biliary Pancreatitis. N Engl J Med 1997;336: 237–242.

25 Sharma VK, Howden CW. Metaanalysis of randomized

controlled trials of endoscopic retrograde cholangiography and endoscopic sphincterotomy for the treatment of acute biliary pancreatitis. Am J Gastroenterol 1999;94:3211–3224.

26 Heinrich S, Schafer M, Rousson V etal. Evidence- based

treatment of acute pancreatitis: a look at established paradigms. Ann Surg 2006;243:154–168.

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associated acute

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retrograde cholangiopancreatography useful in the management of acute biliary pancreatitis? A meta-

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with(out) jaundice: an unjaundiced view. JOP 2009;10:1–7.

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treated by early endoscopic intervention. Panminerva Med 2012;54:65–69.

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cholangiopancreatography strategy versus early conservative management strategy in acute gallstone pancreatitis. Cochrane Database Syst Rev 2012;5:CD009779.

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intervention versus early conservative management in patients with acute gallstone pancreatitis and biliopancreatic obstruction: a randomized clinical trial. Ann Surg 2007;245:10–17.

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cholecystectomy for acute biliary pancreatitis: outcomes of cholecystectomy on first admission and after recurrent biliary pancreatitis. World J Surg 2003;27:256–259.

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management of gallstone pancreatitis in England. Ann R Coll Surg Engl 2012;94:402–406.

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cholecystectomy rates during hospitalizations for acute gallstone pancreatitis: a national survey. Am J Gastroenterol 2008;103:2301–2307.

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Strategies forthe Treatment ofPancreatic Pseudocysts andWalled- Off Necrosis After Acute Pancreatitis: Interventional Endoscopic Approaches

Georg Beyer and Julia Mayerle

Department of Medicine II, LMU University Hospital, Ludwig- Maximilians- University, Munich, Germany

Introduction

A series of trials following improvements in intensive care medicine and endoscopic techniques has led to a paradigm shift in the management of fluid collections developing after an attack of acute pancreatitis: if undertaken at all, interventions should be delayed as much as possible and the least- invasive method should be considered first, before escalating treatment (step- up approach) [1–3]. Intervening a post- acute pancreatic fluid collection (PFC) endoscopically is considered safe once a well- defined wall, then called WOPN (walled- off pancreatic necrosis) has developed, roughly 4weeks into the disease course [4]. Immediate drainage of infected fluid collections is not superior to a delayed approach and with adequate antibiotic treatment, invasive procedures can often be avoided, as demonstrated by a Dutch multicenter trial (POINTER) [5]. Post- acute pancreatic pseudocysts are considered a rare complication arising from a disruption of the main pancreatic duct or major duct branches without considerable necrosis and by definition contain only fluid rich in pancreatic enzymes. In contrast, collections with a fibrous wall originating from pancreatic and/or peripancreatic necrosis are called walledtain variable amounts of solid debris and may reach into areas distant from the gland[6].

off pancreatic necrosis (WOPN), which will con-

Indications forEndoscopic Treatment

In general, only collections that cause symptoms or are at a high risk for severe complications require intervention. Indications for endoscopic intervention are features of infection on imaging or a high suspicion for infection with persistent signs of sepsis that do not improve under

adequate antimicrobial treatment. Less common indications are pain, persistent unwellness, and failure to thrive, jaundice caused by the collection compressing the bile duct, bleeding and arterial pseudoaneurysms, disconnected duct syndrome, gastric outlet obstruction, or pancreatic fistulas.

Endoscopic Drainage vs. Necrosectomy: Choosing theRight Patient

It is currently unclear which collections will improve spontaneously or with conservative management, which require drainage, which need irrigation, and for which collections should a patient undergo advanced endoscopic necrosectomy, as reflected by discordant results of a recent international expert survey [4]. In many cases, patients will initially improve after a drainage procedure and optional nasocystic lavage with few plastic pigtail stents in place to ensure the patency of the tract. A systematic review and meta- analysis comparing 324 patients who underwent conservative management of infected pancreatic necrosis with 157 who underwent necrosectomy concluded that conservative management was successful in 64% and that mortality was lower than in patients who underwent percutaneous treatment [7] although this result is fraught by significant selection bias. Multiple early case series that included pancreatic necrosis and pancreatic abscesses even reported full resolution of these collections without further necrosectomy in over 80% of cases[8–10]. Unfortunately, a nonuniform nomenclature impairs the comparability of these observations. These findings are supported by a recently published Dutch multicentre trial [5]. Between 2015 and 2019, 104 patients with infected pancreatic necrosis occurring within 35 days from onset of symptoms were

Preventing Recurrence by Treating Disconnected Duct Syndrome 285

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randomized to either receive immediate percutaneous or endoscopic drainage with optional necrosectomy or a delayed approach with antibiotic treatment first and escalation to drainage and necrosectomy only if clinical deterioration occured. The median time difference to first invasive procedure between the treatment arms was 10days and there was no difference with regard to complications, organ failure, or death. Patients in the delayed treatment arm had considerably fewer invasive procedures and were less often taken to necrosectomy. Notably, 39 % of patients in the delayed treatment arm did not require any invasive procedures at all, suggesting that immediate drainage, especially before encapsulation of a necritc collection, is not generally beneficial.

However, in patients who do not improve on conservative treatment alone or whose recovery stalls at a certain level, the question remains, how soon should one move from drainage to necrosectomy. A Swedish trial comparing drainage of pseudocysts to pancreatic abscesses with variable amounts of debris showed that the rate of successful drainage was lower in abscesses (94% vs. 80%; P = 0.04) and the risk for complications five times higher (P = 0.02). Of note, all abscesses underwent necrosectomy and lavage later[11]. This suggests that in patients with a higher burden of necrotic material and/or infected collections a more invasive approach may be warranted. The amount of solid debris is best assessed by EUS or MRI.

Transmural endoscopic necrosectomy has been shown to be a safe and efficient way to deal with necrotic collections accessible to endoscopy. It is equally safe and effective when compared to minimally invasive surgical approaches, but appears to be more cost- effective and leads less often to pancreatic fistulas [3,12]. It remains burdened, however, with serious complications even in the hands of experienced investigators[13–16]. In a retrospective comparison of conventional transmural drainage versus necrosectomy in patients with evidence of WOPN on contrast(CT), Gardner etal. showed superiority of direct necrosectomy in terms of treatment success, need for surgery or additional percutaneous drainage, and recurrence [17]. Another registry- based, matched cohort study comparing direct necrosectomy to initial percutaneous access as suggested by the original “step- up approach” in 12 patients showed favorable outcomes for the direct endoscopic approach [18]. Taken together, the current data suggest that mere endoscopic drainage is reasonable and often sufficient in defined collections with minimal amounts of solid material, whereas patients with WOPN and more extensive necrotic material will most likely profit from sometimes repeated sessions of endoscopic removal of necrotic tissue [19]. In unstable patients who develop sepsis due to infected WOPN requiring

enhanced computed tomography

ventilator support and vasopressors, an initial endoscopic or even percutaneous drainage to achieve sepsis control and delayed more advanced endoscopic necrosectomy may be more appropriate. Endoscopic drainage is generally preferred over percutaneous drainage for infected fluid collections, but if drainage is required before a fibrous wall has formed (generally 4weeks) percutaneous drainage is still a valid and frequently used alternative.

The introduction of through the scope, electrocauteryenhanced deployment devices for fully covered selfexpandable lumen- apposing metal stents (LAMS), which allow efficient endoscopic drainage as well as necrosectomy through the same access route, have replaced the use of conventional double- pigtail stents for treatment of WOPN in many centers. Placement of LAMS is faster and comes at lower risk for stent dislocation and rupture of the wall of the collection. However, they bear a considerable risk for stent migration and delayed bleeding if left in place for more then 3 weeks (32.3% vs. 6.9%, P = 0.01) [20] and despite the larger diameter, they are not more effective with regard to resolution of WOPN when compared to conventional pigtails[21].

Due to shorter procedure duration for the initial placement and the option of through- the stent necrosectomy, many centers now use a dual approach: LAMS are used initially to allow for effective large- bore drainage and if needed endoscopic necrosectomy, but will be replaced by multiple pigtail stents later, when collections can be managed in an outpatient setting.

Preventing Recurrence by Treating Disconnected Duct Syndrome

A disconnected pancreatic duct with pancreatic juice leaking into the connected PFC is a major complication of acute pancreatitis and a well- known risk factor for persistence or recurrence of PFC. This includes pseudocysts and WOPN, even after initially successful endoscopic treatment [22,23]. The integrity of the pancreatic duct should therefore be confirmed whenever pancreatic necrosis requiring an intervention is present and preferably by noninvasive methods such as magnetic resonance cholangiopancreatography (MRCP). Although found in up to 50% of patients with acute necrotizing pancreatitis, studies on the optimal management of PFC associated with disconnected pancreatic duct syndrome are scarce. A small randomized controlled trial (n patients with and without disconnected pancreatic duct showed a significant reduction of recurrence (0 vs. 5, P = 0.013) when transmural stents were not removed[24]. The approach of long- term indwelling plastic stents has been adopted for the treatment of WOPN with disconnected pancreatic duct syndrome as reported in two

= 28) recr uiting

286 Strategies forthe Treatment ofPancreatic Pseudocysts andWalled- Off Necrosis After Acute Pancreatitis

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retrospective series including 26 and 33 patients, respectively, in which it appears to have led to a satisfactory outcome with regard to resolution of the collection[25,26]. Another approach involves stenting the pancreatic duct after transmural access and cavity stenting is established. This allows transpapillary drainage of both the content of the connected collection and, more importantly, pancreatic juice away from vital pancreatic tissue distal to the duct disruption [27]. ERCP should be performed with caution in these patients as it is associated with considerable rates of adverse events [28]. A small preliminary study by a group from Mumbai, India described a promising strategy in 42 patients with symptomatic post- acute pancreatic pseudocysts. Three weeks after initially successful drainage using an expandable covered nitinol stent, the patients underwent MRCP. A pancreatic duct leak was detected in three patients and treated successfully by stenting the pancreatic duct with consecutive

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