Novel powered 5.0-mm endoscopic debridement catheter for endoscopic transmural necrosectomy of pancreatic walled-off necrosis: a case series of consecutive patients from a tertiary referral center (with video).

BACKGROUND AND AIMS: EUS-guided drainage and, if required, endoscopic necrosectomy (EN) has become the criterion standard for the treatment of pancreatic walled-off necrosis (WON). A dedicated powered endoscopic debridement system, the EndoRotor (Interscope Inc, Northbridge, Mass, USA), has been introduced as an alternative to snare necrosectomy. This study evaluates the novel EndoRotor catheter, NecroMax 6.0 (Interscope Inc, Whitinsville, Mass, USA), for EN in patients with WON. METHODS: This single-center retrospective case series included consecutive patients with WON treated with the NecroMax 6.0 catheter. Safety, ability to perform EN, and clinical resolution were evaluated. RESULTS: Twenty patients underwent 30 EN procedures with the NecroMax 6.0 catheter. One suspected device-related adverse event was observed (3.3%). In 1 procedure, EN could not be performed because of excessive bending of the endoscope. Eighteen patients (90.0%) achieved clinical resolution. CONCLUSIONS: EN with the NecroMax 6.0 catheter was technically feasible in 96.7% of patients with a low rate of adverse events.

EUS-guided transcolonic drainage and necrosectomy in walled-off necrosis: a retrospective, single-center case series.

Background and study aims Transgastric endoscopic ultrasound (EUS)-guided drainage and, if needed, necrosectomy is the preferred treatment in patients with pancreatic walled-off necrosis. EUS-guided transcolonic or transrectal drainage and necrosectomy may serve as a minimally invasive alternative in cases in which transgastric or percutaneous drainage is either impossible or fails to secure sufficient drainage. In this paper, we retrospectively evaluated the feasibility, safety, and efficacy of the treatment. We included nine patients and found a technical success rate of 100%, clinical success in 89%, and one adverse event (11%). Transrectal/transcolonic endoscopic necrosectomy was needed in seven patients (78%).

EUS-guided drainage of large walled-off pancreatic necroses using plastic versus lumen-apposing metal stents: a single-centre randomised controlled trial.

OBJECTIVE: In treating pancreatic walled-off necrosis (WON), lumen-apposing metal stents (LAMS) have not proven superior to the traditional double pigtail technique (DPT). Among patients with large WON (>15 cm) and their associated substantial risk of treatment failure, the increased drainage capacity of a novel 20-mm LAMS might improve clinical outcomes. Hence, we conducted a study comparing the DPT and 20-mm LAMS in patients with large WON. DESIGN: A single-centre, open-label, randomised, controlled superiority trial using an endoscopic step-up approach in patients with WON exceeding 15 cm in size. The primary endpoint was the number of necrosectomies needed to achieve clinical success (clinical and CT resolution), while the secondary endpoints included technical success, adverse events, length of stay and mortality. RESULTS: Twenty-two patients were included in the DPT group and 20 in the LAMS group, with no significant differences in patient characteristics. The median size of WON was 24.1 cm (P25-P75: 19.6-31.1). The technical success rates were 100% for DPT and 95% for LAMS (p=0.48), while clinical success rates were 95.5% and 94.7%, respectively (p=1.0). The mean number of necrosectomies was 2.2 for DPT and 3.2 for LAMS (p=0.42). Five patients (12%) developed procedure-related serious adverse events (DPT=4, LAMS=1, p=0.35). The median length of stay was 43 (P25-P75: 40-67) and 58 days (P25-P75: 40-86) in the DPT and LAMS groups (p=0.71), respectively, with an overall mortality of 4.8%. CONCLUSIONS: For treating large WON, LAMS are not superior to DPT. The techniques are associated with comparable needs for necrosectomy and hospital stay, and no gross difference in adverse events. TRIAL REGISTRATION NUMBER: NCT04057846.

[Endoscopic transduodenal removal of gallbladder stones in a patient with necrotizing pancreatitis].

This case report describes a 55-year-old man with gallstone-induced necrotizing pancreatitis, colonic fistula and subsequent acute cholecystitis. Due to hostile abdominal milieu, traditional cholecystectomy was not possible, why endoscopic ultrasound (EUS)-guided transduodenal drainage of the gallbladder and endoscopic stone extraction was performed successfully. EUS-guided transduodenal drainage of the gallbladder with endoscopic removal of stones constitutes a safe alternative for patients who have cholecystitis, which is not suitable for cholecystectomy.

National clinical practice guidelines for the treatment of symptomatic gallstone disease: 2021 recommendations from the Danish Surgical Society.

BACKGROUND AND OBJECTIVE: Gallstones are highly prevalent, and more than 9000 cholecystectomies are performed annually in Denmark. The aim of this guideline was to improve the clinical course of patients with gallstone disease including a subgroup of high-risk patients. Outcomes included reduction of complications, readmissions, and need for additional interventions in patients with uncomplicated gallstone disease, acute cholecystitis, and common bile duct stones (CBDS). METHODS: An interdisciplinary group of clinicians developed the guideline according to the GRADE methodology. Randomized controlled trials (RCTs) were primarily included. Non-RCTs were included if RCTs could not answer the clinical questions. Recommendations were strong or weak depending on effect estimates, quality of evidence, and patient preferences. RESULTS: For patients with acute cholecystitis, acute laparoscopic cholecystectomy is recommended (16 RCTs, strong recommendation). Gallbladder drainage may be used as an interval procedure before a delayed laparoscopic cholecystectomy in patients with temporary contraindications to surgery and severe acute cholecystitis (1 RCT and 1 non-RCT, weak recommendation). High-risk patients are suggested to undergo acute laparoscopic cholecystectomy instead of drainage (1 RCT and 1 non-RCT, weak recommendation). For patients with CBDS, a one-step procedure with simultaneous laparoscopic cholecystectomy and CBDS removal by laparoscopy or endoscopy is recommended (22 RCTs, strong recommendation). In high-risk patients with CBDS, laparoscopic cholecystectomy is suggested to be included in the treatment (6 RCTs, weak recommendation). For diagnosis of CBDS, the use of magnetic resonance imaging or endoscopic ultrasound prior to surgical treatment is recommended (8 RCTs, strong recommendation). For patients with uncomplicated symptomatic gallstone disease, observation is suggested as an alternative to laparoscopic cholecystectomy (2 RCTs, weak recommendation). CONCLUSIONS: Seven recommendations, four weak and three strong, for treating patients with symptomatic gallstone disease were developed. Studies for treatment of high-risk patients are few and more are needed. ENDORSEMENT: The Danish Surgical Society.

Simultaneous endoscopic and video-assisted retroperitoneal debridement in walled-off pancreatic necrosis using a laparoscopic access platform: Two case reports.

BACKGROUND: Infected walled-off necrosis is a potentially life-threatening complication of necrotizing pancreatitis. While some patients can be treated by drainage alone, many patients also need evacuation of the infected debris. Central necroses in relation to the pancreatic bed are easily reached via an endoscopic transluminal approach, whereas necroses that involve the paracolic gutters and the pelvis are most efficiently treated via a percutaneous approach. Large and complex necroses may need a combination of the two methods. CASE SUMMARY: Transluminal and percutaneous drainage followed by simultaneous endoscopic and modified video-assisted retroperitoneal debridement was carried out in two patients with very large (32-38 cm), infected walled-off necroses using a laparoscopic access platform. After 34 d and 86 d and a total of 9 and 14 procedures, respectively, complete regression of the walled-off necroses was achieved. The laparoscopic access platform improved both access to the cavities as well as the overview. Simultaneous transluminal and percutaneous necrosectomy are feasible with the laparoscopic access platform serving as a useful adjunctive. CONCLUSION: This approach may be necessary to control infection and achieve regression in some patients with complex collections.

Clinical outcomes following endoscopic or video-assisted retroperitoneal management of acute pancreatitis with large (>15 cm) walled-off pancreatic necrosis: Retrospective, single tertiary center cohort study.

OBJECTIVE: Acute pancreatitis with walled-off necrosis (WON) is associated with considerable morbidity and mortality. Previous studies have evaluated outcomes in WON collections of limited size, while data about large WON with long-term follow-up are lacking. We aimed to report our experience in managing large WON. METHODS: Between 2010 and 2020, consecutive patients with large (>15 cm) WON were identified from a prospectively maintained database. Patients with chronic pancreatitis or an index intervention 90 days or more from the debut of symptoms were excluded. We registered clinical and technical outcomes following minimally invasive treatment in WON >15 cm. Follow-up was a minimum of 1 year. RESULTS: Overall, 144 patients with WON >15 cm, with a median age of 60 (interquartile range [IQR] 49-69) years, were included. The median WON size was 19.2 cm (IQR 16.8-22.1). Most patients were treated with endoscopic transluminal drainage (93%). The median length of stay was 53 days (IQR 39-76) and 61 (42%) patients needed intensive care support during their hospital stay. As 143 patients (99%) were managed using endoscopic or video-assisted retroperitoneal techniques, only one (0.7%) patient needed an open necrosectomy. Procedure-related adverse events occurred in 10 (7%) patients. Overall, 24 patients (17%) died during admission, all due to multiorgan failure. The median follow-up was 35 months (IQR 15-63.5). Complete resolution was achieved in all remaining patients. CONCLUSION: Minimally invasive treatment of large WON is feasible, with a minimal need for surgery and acceptable rates of morbidity and mortality.

Short- and Long-Term Outcomes After Multimodal Treatment of Pancreatic Duct Leakage in Patients With Chronic Pancreatitis.

OBJECTIVES: In patients with chronic pancreatitis, pancreatic duct leakage is associated with a prolonged disease course and serious complications. We aimed to assess the efficacy of this multimodal treatment of pancreatic duct leakage. METHODS: In a retrospective design, patients with chronic pancreatitis, an amylase content greater than 200 U/L in either ascites or pleural fluid and treated between 2011 and 2020, were evaluated. The primary end point was treatment success. RESULTS: Twenty-seven patients (22 males, median age 60, median American Society of Anesthesiologists score 3) were included.Endoscopic retrograde pancreatography was performed in 23 patients (85%) with transpapillary stenting of the main pancreatic duct in 22 patients (96%). Pancreatic sphincterotomy and dilation of the main pancreatic duct were done in 14 patients (61%) and 17 patients (74%), respectively. Twelve patients (44%) were treated with somatostatin analogs, parenteral nutrition, and were "nil by mouth" for a median of 11 days (range, 4-34 days). Six patients (22%) had extracorporeal shock wave lithotripsy due to pancreatic duct stones. One patient (4%) was referred for surgery. All 23 patients (100%) were treated with success after a median of 21 days (range, 5-80 days). CONCLUSIONS: Multimodal treatment of pancreatic duct leakage is effective, with minimal need for surgery.

Validation of the Endoscopic Part of the Spigelman Classification for Evaluating Duodenal Adenomatosis in Familial Adenomatous Polyposis: A Prospective Study of Interrater and Intrarater Reliability.

INTRODUCTION: In patients with familial adenomatous polyposis, the Spigelman classification is recommended for staging and risk stratification of duodenal adenomatosis. Although the classification has been used for decades, it has never been formally validated. METHODS: We included consecutive FAP patients undergoing upper gastrointestinal endoscopic surveillance and evaluated the inter- and intrarater reliability of the Spigelman classification. RESULTS: The interrater reliability of the endoscopic parameters and the Spigelman classification was good and excellent, respectively. The intrarater reliability of the endoscopic parameters and the Spigelman classification was moderate and good, respectively. DISCUSSION: The results support continued use of the Spigelman classification as the primary end point for future studies and as key endoscopic performance measure.

[Videoscopic-assisted retroperitoneal debridement ofnecrotising pancreatitis].

Acute necrotising pancreatitis is a condition associated with high morbidity and mortality, and for decades surgical intervention was the gold standard for treatment of symptomatic pancreatic necrosis. A shift towards minimally invasive interventions has reduced the mortality significantly as summarised in this review. Studies comparing open necrosectomy with videoscopic-assisted retroperitoneal debridement (VARD) have demonstrated that VARD lowers morbidity and mortality. When endoscopic therapy is impossible, VARD is recommended as the preferred surgical intervention for symptomatic necrotising pancreatitis.

[Endoscopic ultrasound-guided establishment of transmural anastomoses in the upper gastrointestinal tract].

The development of endoscopic ultrasound and lumen-apposing metal stents has resulted in novel therapeutic opportunities with the possibility of establishing a persistent transmural anastomosis for the treatment of multiple gastrointestinal disorders. This review presents the applications and the evidence of endoscopic ultrasound and lumen-apposing metal stents. The modality is an alternative for several upper gastrointestinal disorders. Further research and future technological development will show the final position of this therapy in the current treatment algorithm.

Endoscopic treatment with transmural drainage and necrosectomy for walled-off necrosis provides favourable long-term outcomes on pancreatic function.

BACKGROUND AND AIMS: Several studies have shown improved short-term outcome with endoscopic transmural drainage and necrosectomy for the treatment of walled-off pancreatic necrosis. However, knowledge on the long-term prognosis after such treatment is limited. The aim of present study was to evaluate long-term outcomes in patients endoscopically treated with transmural drainage and necrosectomy. METHODS: We retrospectively follow up 125 patients with walled-off pancreatic necrosis treated with endoscopic transmural drainage and necrosectomy in 2010-2017. All patients received plastic pigtail stents and nasocystic catheter. Additional external drainage was performed in 41 patients. Main outcomes were survival, pancreatic function, development of co-morbidities, ability to work and social status. RESULTS: During a median follow-up of 4.3 years, nine (7%) patients died. Seven deaths were unrelated to pancreatic disease, and two patients died of pancreatic cancer. Twenty-two (18%) patients developed exocrine pancreatic insufficiency. Thirty-six (32%) previous non-diabetics developed endocrine insufficiency. Endoscopic necrosectomy during admission (odds ratio (OR) = 1.28, 95% confidence interval (CI) 1.05-1.56; p = 0.015) and therapy on the main pancreatic duct (OR = 8.08, 95% CI 2.43-26.9; p < 0.001) during follow-up predicted development of exocrine insufficiency. Severity on computed tomography predicted endocrine insufficiency (OR = 1.61, 95% CI 1.24-2.09; p < 0.001). Most patients regained their working capacity and preserved their marital status. CONCLUSIONS: This study provides robust data on the long-term outcome of patients with walled-off pancreatic necrosis treated with endoscopic transmural drainage and necrosectomy. The favourable outcomes on survival, pancreatic function and social status support current recommendations of endoscopic transmural drainage and necrosectomy being the treatment of choice for walled-off pancreatic necrosis.

Energy expenditure and loss of muscle and fat mass in patients with walled-off pancreatic necrosis: A prospective study.

OBJECTIVE: Ensuring adequate nutritional support in patients with walled-off pancreatic necrosis (WON) is challenging and weight loss is often considerable. The aim of this study was to evaluate resting energy expenditure (REE) and body composition in patients with WON. METHODS: We prospectively included 18 patients (67% men; median age 63 y; 44% gallstones; 39% alcohol) with WON undergoing endoscopic transgastric drainage and necrosectomy. Patients were followed for 4 wk after admission. We assessed hand-grip strength, REE using indirect calorimetry, and body composition with dual-energy x-ray absorptiometry to assess the percentage change in muscle mass (MM) and fat mass (FM). Data are summarized using medians (range). RESULTS: At baseline, the median body mass index was 27.9 kg/m2 (17.7-35.6 kg/m2). Fifteen patients (83%) had infected WON. Eight patients (44%) received total or supplemental parenteral nutrition. The median percentage loss in MM was 0.31% and FM was 6.2%. The median REE was 6870 kJ (3255-8870 kJ) at baseline. Compared with the predicted REE, the measured REE was 1049 kJ higher (-3065 to 2126 kJ) at baseline and -951 kJ lower (-2600 to 3202 kJ) at 4 wk. The difference between the predicted and measured REE at baseline was correlated with the percentage loss in MM (P = 0.043) and FM (P = 0.026). Additionally, patients with infected WON had significantly higher REE (P = 0.003). CONCLUSION: In patients with WON, an increased REE appears to predict increased muscle and fat loss. Additional studies are necessary to evaluate if REE may be used to improve nutritional support.

The cost of endoscopic treatment for walled-off pancreatic necrosis.

BACKGROUND: Use of minimally invasive techniques has reduced mortality in walled-off pancreatic necrosis (WON) but may be costly. The aim of this study was to evaluate the actual costs associated with the endoscopic management of patients with WON. METHODS: We included a retrospective cohort of WON patients treated with endoscopic, transgastric drainage and necrosectomy (ETDN) during 2013-2014. Costs were calculated for six sub-areas based on a micro-costing model. Students T-test and non-parametric analysis of variance were performed to evaluate costs in relation to disease etiology and outcome. RESULTS: We included 58 patients (50% men, median age 57 years). The most common etiologies were gallstones (57%) and alcohol (19%). Nine patients (16%) died during admission. The median length of stay was 50 days (IQR 31 days). Eighteen patients (31%) needed treatment in our intensive care unit with a median length of stay of 16 days (IQR 31 days). The mean costs and standard deviation of costs (SD) per patient were: diagnostic imaging $2,431 ($2,301), laboratory tests $3,579 ($2,477), blood products $982 ($1,734), endoscopic treatment $3,794 ($1,777), medicine $5,440 ($6,656), and ward cost $41,260 ($35,854). The mean total cost was $57,486 ($46,739). Post-ERCP pancreatitis and mortality predicted higher costs. CONCLUSIONS: This study sheds light on the different costs associated with endoscopic treatment of WON. As nearly three quarters of the costs are related to ward care, initiatives aimed at reducing the length of hospital stay may have a great impact on making endoscopic treatment more cost effective.

Characterisation of the fibroinflammatory process involved in progression from acute to chronic pancreatitis: study protocol for a multicentre, prospective cohort study.

INTRODUCTION: Chronic pancreatitis (CP) is thought to present the end stage of a continuous disease process evolving from acute pancreatitis (AP), over recurrent AP, to early and end-stage CP. Due to the irreversible nature of CP, early detection and prevention is key. Prospective assessment based on advanced imaging modalities as well as biochemical markers of inflammation, fibrosis and oxidative stress may provide a better understanding of the underlying pathological processes and help identify novel biomarkers of disease with the ultimate goal of early diagnosis, intervention and prevention of disease progression. This paper describes the protocol of a prospective multicentre cohort study investigating the fibroinflammatory process involved in progression from acute to CP using state-of-the-art diagnostic imaging modalities and circulating biomarkers of inflammation, fibrosis and oxidative stress. METHODS AND ANALYSIS: Adult control subjects and patients at different stages of CP according to the M-ANNHEIM system will be recruited from outpatient clinics at the participating sites and form three cohorts: controls (n=40), suspected CP (n=60) and definitive CP (n=60). Included patients will be followed prospectively for 15 years with advanced MRI and contrast-enhanced endoscopic ultrasound with elastography, assessment of endocrine and exocrine pancreatic function, biochemical and nutritional assessment, and evaluation of pain processing using quantitative sensory testing. Blood samples for a biobank will be obtained. The purpose of the biobank is to allow analyses of potential circulating biomarkers of disease progression, including markers of inflammation, fibrosis and oxidative stress. ETHICS AND DISSEMINATION: Permissions from the Regional Science Ethics committee and the Regional Data Protection Agency have been obtained. We will submit the results of the study for publication in peer-reviewed journals regardless of whether the results are positive, negative or inconclusive.

Pulmonary dysfunction due to combination of extra-pulmonary causes and alveolar damage is present from first the day of hospital admission in the early phase of acute pancreatitis.

BACKGROUND: Only few studies have attempted to evaluate the pulmonary function in the early phase of acute pancreatitis (AP), although pulmonary dysfunction is the most frequent complication in the early phase of AP. We aimed to evaluate the changes in pulmonary function tests during the early phase of AP. METHODS: Prospective cohort study including 44 patients (52% men; median age 54 years) admitted with first attack of AP and 22 healthy controls. Patients underwent assessments on day 1, 2, 3, 6, and 10 as well as one month after discharge. Pulmonary function tests included the % predicted: forced expiratory volume during the first second (FEV1), forced vital capacity (FVC), total lung capacity (TLC), diffusion lung capacity (DLCO) and the ratio between DLCO and alveolar volume (DLCO/VA). RESULTS: In total, 9% developed severe acute pancreatitis, 7% died, and 14% required treatment at the intensive or semi-intensive care unit. From admission, patients had impaired FEV1, FVC, DLCO, and TLC compared with controls (p < 0.0001 in all analyses). Patients with CRP >150 mg/L had significantly lower lung function tests. One month after discharge, lung function tests improved but patients had lower FEV1 (p = 0.014), FVC (p = 0.022), TLC (p = 0.020), and DLCO (p < 0.001) compared with controls. CONCLUSION: This study found that patients with AP had evidence of pulmonary impairment from the first day after hospital admission. The impairment lasted several weeks after hospital discharge.

Prophylactic pancreatic duct stenting in severe acute necrotizing pancreatitis: a prospective randomized study.

BACKGROUND: Pancreatic duct disruption is common and is associated with high morbidity in cases of acute necrotizing pancreatitis (ANP). In this study, we tested the feasibility and safety of prophylactic pancreatic duct stenting (PPDS) in ANP and compared PPDS with conservative treatment. METHODS: We prospectively enrolled patients (aged 18 - 75 years) diagnosed with ANP between February 2011 and July 2015. These patients were prospectively randomized to receive PPDS or conservative treatment at two tertiary centers. PPDS was performed as soon as possible after randomization. RESULTS: Concern regarding iatrogenic infections with pancreatic necrosis in the PPDS group prompted interim analysis, which confirmed a highly elevated risk. Thus, the trial was terminated prematurely for ethical reasons. Of the 11 patients in the PPDS group, all patients with successful pancreatic duct placement (5/5, 100 %) presented with infection, compared with only 3 of the 13 patients (23.1 %) in the conservative treatment group (P = 0.01). Analysis revealed success rates of 63.6 % for pancreatic duct cannulation, 45.5 % for pancreatic duct stenting, and 18.2 % for placement of a stent bridging the necrosis. Cannulation and stenting failures were due to duodenal edema and pancreatic duct stenosis. CONCLUSIONS: PPDS in ANP is associated with an unacceptably high risk of pancreatic necrosis infection. In addition, the procedure is technically challenging due to duodenal edema and ductal stenosis.