Direct Endoscopic Necrosectomy Research Articles

What's Behind it all: A Retrospective Cohort Study of Retrogastric Pancreatic Necrosis Management.

To compare outcomes of laparoscopic transgastric necrosectomy (LTN) and direct endoscopic necrosectomy (DEN) in the management of retrogastric walled-off necrosis. Surgical and endoscopic transgastric approaches are used to manage retrogastric pancreatic necrosis. Studies comparing these treatment modalities are lacking but would influence contemporary practice patterns. LTN or DEN treated patients at Stanford University Hospital between 2011 and 2023 were identified. Cohort data included demographics, core pancreatitis care benchmarks, and clinical outcomes (total debridement time, new-onset endocrine and exocrine pancreatic insufficiency) as well as re-intervention, 30-day readmission, complication, and mortality rates. Long-term follow-up was also compared between intervention arms. Multivariable linear regression was used to assess the interaction between admission APACHE-II score and intervention on length of stay (LOS). 106 patients (62% LTN, 38% DEN) were identified. Demographic and core pancreatitis benchmark data were similar between cohorts. 30-day readmission, complication, and mortality rates for surgical and endoscopic approaches were also similar: 23% vs. 25% (P = 0.98), 42% vs. 40% (P = 0.97), and 3% vs. 3% (P > 0.99). Median LTN total debridement time (minutes) was 131 vs. 134 for DEN, however, complete debridement was achieved with only 1 LTN compared to 3 DENs (P<0.01). While not statistically significant, LOS and unplanned intervention rates were less for LTN (8 vs. 10 days, P = 0.41 and 6% vs. 15%, P = 0.24). Multivariable analysis revealed a significant interaction between APACHE-II scores and LOS for LTN compared to DEN, which translated into a length of stay reduction for higher APACHE-II scoring patients (P = 0.02). LTN is a safe and efficient treatment modality for walled-off necrosis, and compared to DEN, can reduce the LOS in high APACHE-II score patients. While additional comparative research between the two intervention types is needed, this study supports a role for a surgical approach in the management of retrogastric pancreatic necrosis.

Direct endoscopic necrosectomy: Pilot study of a new dedicated device.

Background and study aims Direct endoscopic necrosectomy (DEN) represents the first-line treatment for walled-off necrosis (WON). However, DEN has a non-negligible rate of overall adverse events (AE) and is time-consuming due to the lack of dedicated devices. This pilot study was designed to evaluate the feasibility and safety of a novel dedicated device for DEN named Necrolit. Patients and methods In this multicenter retrospective analysis,16 patients with WON who underwent DEN using Necrolit were compared with a control group treated with non-dedicated devices. Technical success, AEs, clinical success, number of procedures per patient, procedure time, and length of hospital stay were evaluated. Necrolit technical performance indicators were also studied. Results Technical success was obtained in all patients in both groups. In the Necrolit group, the overall AE rate was 10.1% vs. 15.9% in the control group. Clinical success was 100% in the Necrolit group vs. 81.3% in the control group. Patients treated with Necrolit underwent a slightly lower mean number of procedures (4.1 ± 2.3 vs. 5.1 ± 1.9) with comparable mean procedure time (67.8 ± 39 minutes vs. 70.1 ± 32.6 minutes). Mean duration of hospital stay was 39.4 days (± 30.9) in the Necrolit group vs. 43 days (± 29.4) in the control group. Device-related technical performance was rated positively. Conclusions DEN with Necrolit appears feasible and safe.

Immediate Direct Endoscopic Necrosectomy Versus Delayed Direct Endoscopic Necrosectomy

BACKGROUND AND AIMSLumen-apposing metal stents (LAMSs) are effective in resolving walled-off necrosis (WON) of the pancreas and enable direct endoscopic necrosectomy (DEN). However, optimal DEN timing is controversial. We aimed to study if early DEN shortens WON resolution time. METHODSWe retrospectively reviewed patients who underwent LAMS placement for WON at a tertiary center. We collected patient demographics, WON characteristics, DEN sessions, and outcomes. We compared those who underwent immediate DEN (iDEN; index DEN at LAMS placement) and delayed DEN (dDEN; index DEN on a separate day from LAMS placement). We identified predictors for resolution time via linear regression, and constructed Nelson-Aalen cumulative hazards curves showing resolution time stratified by index DEN timing. RESULTSBetween January 2011 and June 2019, 175 patients underwent LAMS placement for peripancreatic fluid collections, 155 (88.6%) of which were WON. Of these, 50 (32.3%) required DEN. The majority were male (80%) with an average age of 52.5 years. WON size and double-pigtail stent use through LAMS were similar. Overall, the mean time to WON resolution was 90.6 days, 44.5 (iDEN) versus 100.7 (dDEN), P = 0.02, with similar DEN sessions (P = 0.64). The average length of stay was 0.9 in iDEN versus 14.7 days in dDEN (P = 0.03). All had WON resolution with a similar adverse event rate (18.5% iDEN vs 25.1% dDEN, P = 0.45). In multivariate analysis, double-pigtail stent use suggested greater complexity and longer WON resolution time (P = 0.005). CONCLUSIONDespite similar DEN sessions, LAMS with iDEN significantly reduced resolution time compared with dDEN. Only one-third of WON patients treated with LAMS placement required DEN.

Timing It Right: Endoscopic Necrosectomy for Infected Necrotizing Pancreatitis

AbstractThe endoscopic step-up drainage approach involving initial drainage followed by, if required, direct endoscopic necrosectomy (DEN) is the preferred management approach for symptomatic pancreatic necrotic collections. However, limited data suggests that immediate DEN during initial stent placement may hasten clinical recovery by quicker resolution of systemic inflammatory response. However, because of concerns about adverse effects, especially gastric perforation and bleeding, most endoscopists prefer delayed DEN. In this news and views, we discuss a recently published randomized controlled trial that compared upfront necrosectomy at the index intervention versus as a step-up for patients with infected necrotizing pancreatitis.

New-onset Diabetes Mellitus after EUS-guided Drainage with LAMS: A Pilot Study.

Walled-off necrosis (WON) is a serious complication of severe pancreatitis, patients with necrotizing pancreatitis having an increased risk of developing diabetes mellitus (DM). The aim of this study was to assess the frequency of new-onset diabetes (NOD) in patients with symptomatic WON after endoscopic ultrasound (EUS)-guided drainage with lumen-apposing metal stents (LAMS). We retrospectively analyzed a prospectively collected database of patients with symptomatic WON treated by EUS-guided drainage with LAMS in a tertiary referral center. The patients were followed-up for at least 12 months after stent removal. These patients were compared with age- and sex-matched asymptomatic WON controls without interventional treatment and healthy controls to assess the one-year occurrence of DM. Diabetes was defined according to the American Diabetes Association criteria. Of the 50 patients with symptomatic WON included in the study (male/female ratio, 33:17; median age, 60 years), 13 patients (26%) had pre-existing DM and were excluded. Ten of the remaining 37 patients (27%) without prior DM developed NOD within one year after stent removal, this frequency being higher than in asymptomatic WON controls (18.9%, p=0.581) and healthy controls (2%, p = 0.002). In the symptomatic WON group, NOD patients compared to non-DM patients were older (63.5 vs. 56 years old, p=0.042), had more frequent necrosis > 50% of the pancreatic parenchyma (p=0.002) and had a body-tail location of WON (p<0.001). On multivariate analysis, the number of direct endoscopic necrosectomy (DEN) sessions was the only significant factor for NOD occurrence (OR=7.05, p=0.010). NOD patients had poor glycemic control and required more DEN sessions to achieve WON resolution than patients with prior DM (p=0.017). In patients with symptomatic WON treated by EUS-guided drainage, DM occurred in 27% of previously non-diabetic patients within one year of follow-up. Patients with extensive pancreatic necrosis were more likely to develop NOD, a high number of DEN sessions being a significant risk factor for NOD occurrence.

Endoscopic Ultrasound-Guided Drainage of Pancreatic Fluid Collections: Not All Queries Are Already Solved.

Pancreatic fluid collections (PFCs) are well-known complications of acute pancreatitis. The overinfection of these collections leads to a worsening of the prognosis with an increase in the morbidity and mortality rate. The primary strategy for managing infected pancreatic necrosis (IPN) or symptomatic PFCs is a minimally invasive step-up approach, with endosonography-guided (EUS-guided) transmural drainage and debridement as the preferred and less invasive method. Different stents are available to drain PFCs: self-expandable metal stents (SEMSs), double pigtail stents (DPPSs), or lumen-apposing metal stents (LAMSs). In particular, LAMSs are useful when direct endoscopic necrosectomy is needed, as they allow easy access to the necrotic cavity; however, the rate of adverse events is not negligible, and to date, the superiority over DPPSs is still debated. Moreover, the timing for necrosectomy, the drainage technique, and the concurrent medical management are still debated. In this review, we focus attention on indications, timing, techniques, complications, and particularly on aspects that remain under debate concerning the EUS-guided drainage of PFCs.

A novel lumen-apposing metal stent for endoscopic drainage of symptomatic pancreatic fluid collections: a retrospective study.

Previous studies showed that lumen-apposing metal stent (LAMS) provides a feasible route to perform direct endoscopic necrosectomy. However, the high risk of bleeding and migration induced by the placement of LAMS attracted attention. The aim of this study was to evaluate the safety and effectiveness of a novel LAMS. In this retrospective study, we enrolled patients with symptomatic pancreatic fluid collections (PFCs) to perform EUS-guided drainage with a LAMS in our hospital. Evaluation variables included technical success rate, clinical success rate, and adverse events. Thirty-two patients with a mean age of 41.38 ± 10.72 years (53.1% males) were included in our study, and the mean size of PFC was 10.06 ± 3.03 cm. Technical success rate and clinical success rate reached 96.9% and 93.8%, respectively. Stent migration occurred in 1 patient (3.1%), and no stent-induced bleeding occurred. The outcomes of using LAMS in 10 patients with pancreatic pseudocyst and 22 patients with walled-off necrosis were comparable. Compared with pancreatic pseudocyst, walled-off necrosis needed more direct endoscopic necrosectomy times to achieve resolution (P = 0.024). Our study showed that the novel LAMS is effective and safe for endoscopic drainage of PFCs with a relatively low rate of adverse events. Further large-scale multicenter studies are needed to confirm the present findings.

Impact of Direct Endoscopic Necrosectomy on Recurrence of Symptoms or Fluid Collections Following Successful Endoscopic Transmural Drainage of Walled-off Necrosis in Disconnected Pancreatic Duct

Abstract Background The impact of direct endoscopic necrosectomy (DEN) on risk of recurrence of symptoms or pancreatic fluid collections (PFCs) in patients with disconnected pancreatic duct (DPD) has not been previously evaluated. Objective To compare the risk of recurrence of PFC in patients with walled-off necrosis (WON) and DPD undergoing DEN with that of not requiring DEN and not having permanent indwelling plastic stents. Methods Retrospective analysis of database of patients with WON successfully treated with transmural metal stents over the past 5 years was done to identify patients with DPD and not having permanent indwelling transmural stents. These patients were divided into two groups: Group A: patients undergoing DEN and Group B: patients not requiring DEN. Results Seventeen patients required DEN (Group A; mean age 37.8 years) and 21 patients were successfully treated without DEN (Group B; mean age: 37.7 years). In Group A, none of the patients developed either recurrence of symptoms or PFC over a mean follow-up period of 7 months. In Group B, 5 of 21 (23.8%) patients developed either recurrence of pain (n = 2) or PFC (n = 3) over a mean follow-up period of 22 months. New-onset diabetes mellitus developed in five (29%) patients in Group A and two (9%) patients in Group B. None of the patients in either group developed steatorrhea. Conclusion Patients with WON and DPD treated with lumen apposing metal stent and requiring DEN seem to be having low risk of developing recurrence of pain or PFC.

Early versus late endoscopic treatment of pancreatic necrotic collections: A systematic review and meta-analysis.

Background and study aims Recently studies have compared early (<4 weeks) vs. late or standard (>4 weeks) endoscopic treatment of pancreatic necrotic collections (PNC) and have reported favorable results for early treatment. In this meta-analysis, we compared the efficacy and safety of early vs. late endoscopic treatment of PNC. Patients and methods We reviewed several databases from inception to September 30, 2021 to identify studies that compared early with late endoscopic treatment of PNC. Our outcomes of interest were adverse events (AEs), resolution of PNC, performance of direct endoscopic necrosectomy, need for further interventions, and mean number of endoscopic necrosectomy sessions. We calculated pooled risk ratios (RRs) with 95% confidence intervals (CIs) for categorical variables and mean differences (MDs) with 95% CIs for continuous variables. Data were analyzed by random effect model. Heterogeneity was assessed by I 2 statistic. Results We included four studies with 427 patients. We found no significant difference in rates of AEs, RR (95% CI) 1.70 (range, 0.56-5.20), resolution of necrotic or fluid collections, RR (95% CI) 0.89 (range, 0.71-1.11), need for further interventions, RR (95% CI) 1.47 (range, 0.70-3.08), direct necrosectomy, RR (95% CI) 1.39 (range, 0.22-8.80), mortality, RR (95% CI) 2.37 (range, 0.26-21.72) and mean number of endoscopic necrosectomy sessions, MD (95% CI) 1.58 (range,-0.20-3.36) between groups. Conclusions Early endoscopic treatment of PNC can be considered for indications such as infected necrosis or sterile necrosis with symptoms or complications; however, future large multicenter studies are required to further evaluate its safety.

Endoscopic ultrasonography-guided transluminal drainage (EUS-TD) and direct endoscopic necrosectomy (DEN) for typical late complications associated with acute pancreatitis

Endoscopic ultrasonography-guided transluminal drainage (EUS-TD) and direct endoscopic necrosectomy (DEN) for typical late complications associated with acute pancreatitis

Walled-off Pancreatic Necrosis: Multidisciplinary Perspective

AbstractWalled-off pancreatic necrosis is a potential sequela of necrotizing pancreatitis. When drainage is indicated, such as in the setting of local complications (biliary or bowel obstruction), superinfection, or the collection causing abdominal pain, endoscopic, percutaneous, and surgical approaches are possible. Endoscopic drainage with or without placement of a luminal apposing metal stent and possible direct endoscopic necrosectomy is the preferred approach for drainage given good outcomes and patient comfort. In some cases, due to location and/or lack of a mature wall, endoscopic drainage is not possible or may be ineffective. In such cases, percutaneous and/or surgical drainage may be necessary.

Direct endoscopic necrosectomy using the novel 5-mm powered endoscopic debridement device: The larger winner?

Video 1Direct endoscopic necrosectomy using the novel 5-mm powered endoscopic debridement device for walled-off pancreatic necrosis, following endoscopic cystogastrostomy with lumen-apposing metal stent.

Time to think prime times for treatment of necrotizing pancreatitis: A pendulum conundrum.

Pancreatic fluid collections (PFCs) typically develop as local complications of acute pancreatitis and complicate the clinical course of acute pancreatitis patients with potentially fatal clinical outcomes. Interventions are required in cases of symptomatic walled-off necrosis (matured PFC with necrosis) and pancreatic pseudocysts (matured PFC without necrosis). In the management of necrotizing pancreatitis and walled-off necrosis, endoscopic ultrasound (EUS)-guided transluminal drainage combined with on-demand endoscopic necrosectomy (i.e., the step-up approach) is increasingly utilized as a less invasive treatment modality compared to a surgical or percutaneous approach. Through the substantial research efforts and development of specific devices and stents (e.g., lumen-apposing metal stents), endoscopic techniques of PFC management have been standardized to some extent. However, there has been no consensus about timing of carrying out each treatment step; for instance, it is uncertain when direct endoscopic necrosectomy should be initiated and finished, and when a plastic or metal stent should be removed following clinical treatment success. Despite emerging evidence for the effectiveness of non-interventional supportive treatment (e.g., antibiotics, nutritional support, irrigation of the cavity), there has been only a limited data on the timing of starting and stopping the treatment. Large studies are required to optimize the timing of those treatment options and improve clinical outcomes of patients with PFCs. In this review, we summarize the current available evidence on the indications and timing of interventional and supportive treatment modalities for this patient population and discussed clinical unmet needs that should be addressed in future research.

WONDER-01: immediate necrosectomy vs. drainage-oriented step-up approach after endoscopic ultrasound-guided drainage of walled-off necrosis—study protocol for a multicentre randomised controlled trial

BackgroundWith the increasing popularity of endoscopic ultrasound (EUS)-guided transmural interventions, walled-off necrosis (WON) of the pancreas is increasingly managed via non-surgical endoscopic interventions. However, there has been an ongoing debate over the appropriate treatment strategy following the initial EUS-guided drainage. Direct endoscopic necrosectomy (DEN) removes intracavity necrotic tissue, potentially facilitating early resolution of the WON, but may associate with a high rate of adverse events. Given the increasing safety of DEN, we hypothesised that immediate DEN following EUS-guided drainage of WON might shorten the time to WON resolution compared to the drainage-oriented step-up approach.MethodsThe WONDER-01 trial is a multicentre, open-label, superiority, randomised controlled trial, which will enrol WON patients aged ≥ 18 years requiring EUS-guided treatment in 23 centres in Japan. This trial plans to enrol 70 patients who will be randomised at a 1:1 ratio to receive either the immediate DEN or drainage-oriented step-up approach (35 patients per arm). In the immediate DEN group, DEN will be initiated during (or within 72 h of) the EUS-guided drainage session. In the step-up approach group, drainage-based step-up treatment with on-demand DEN will be considered after 72–96 h observation. The primary endpoint is time to clinical success, which is defined as a decrease in a WON size to ≤ 3 cm and an improvement of inflammatory markers (i.e. body temperature, white blood cell count, and C-reactive protein). Secondary endpoints include technical success, adverse events including mortality, and recurrence of the WON.DiscussionThe WONDER-01 trial will investigate the efficacy and safety of immediate DEN compared to the step-up approach for WON patients receiving EUS-guided treatment. The findings will help us to establish new treatment standards for patients with symptomatic WON.Trial registrationClinicalTrials.gov NCT05451901, registered on 11 July 2022. UMIN000048310, registered on 7 July 2022. jRCT1032220055, registered on 1 May 2022.

Pancreatitis sepsis: Evolution and principles in the management of necrotizing pancreatitis

Outcomes from some recent clinical trials have helped to improve the management of necrotizing pancreatitis over the last 2 decades. The location of the retroperitoneal collection, previous gastric surgery, patient preference, and medical expertise dictates a minimally invasive surgical step-up versus endoscopic approach. Endoscopic drainage is facilitated by either a plastic or metallic stent. Direct endoscopic necrosectomy is performed for lack of improvement after endoscopic drainage. The surgical approach is accomplished by minimally invasive surgery with either video-assisted retroperitoneal debridement or laparoscopic drainage. A multidisciplinary team with appropriate expertise should care for patients with necrotizing pancreatitis. This brief review summarizes the landmark clinical trials, compares the benefits and roles of endoscopic, surgical, and percutaneous interventions, and discusses treatment algorithms for necrotizing pancreatitis in the modern era.

Novel hemostatic option using self-assembling peptide gel for endoscopic necrosectomy-related bleeding.

Bleeding is the most common complication during direct endoscopic necrosectomy (DEN) for walled-off pancreatic necrosis (WON) [1]. However, there is no consensus on the optimal hemostatic method for DEN-related bleeding. Here, we demonstrate endoscopic hemostasis using PuraStat (3D-Matrix Europe SAS, France), a novel self-assembling peptide hemostatic gel for DEN-related bleeding ([Video 1]).

Placement of Plastic Stents after Direct Endoscopic Necrosectomy through a Novel Lumen-Apposing Metal Stent for Effective Treatment of Laterally Extended Walled-Off Necrosis: A Pilot Study.

Direct endoscopic necrosectomy (DEN) using a lumen-apposing metal stent (LAMS) is a standard therapy for the management of symptomatic walled-off necrosis (WON). Here, we demonstrated the efficacy of the routine placement of long plastic stents after a DEN session to treat laterally extended WON. Patients (n = 6) with symptomatic laterally extended WON who underwent DEN after long plastic stent placement were included. The primary endpoint was clinical efficacy of the procedure. The technical and clinical success rates were 100% without major adverse events. The WON extended to the pelvic cavity or pericolic area, and the WON size was between 18.6 and 35.8 cm in length. The median number of DEN sessions was 10 (range 6-16), and two or three long plastic stents were placed after every DEN session. Only one patient suffered from pneumoperitoneum during DEN, which spontaneously resolved within 20 min. Placement of a long plastic stent after DEN using LAMS is a minimally invasive and effective treatment for symptomatic laterally extended WON. Further studies are needed to define the indications and most suitable patients.

Direct endoscopic necrosectomy with the newly developed 6-mm powered rotating resection catheter: When size matters.

Direct endoscopic necrosectomy with the newly developed 6-mm powered rotating resection catheter: When size matters.

Response to "The second shot to walled-off necrosis: The sooner the better versus sooner or later".

We appreciate Sato et al's interest in our study. There has been conflicting evidence on the optimal timing of direct endoscopic necrosectomy (DEN).1 In a study by Yan et al., the number of necrosectomies required to achieve resolution was fewer in patients undergoing immediate DEN. In addition, in multivariable analysis, DEN at the time of initial lumen apposing metal stent placement was the only positive predictor for decreasing time to clinical success.2 One concern raised by Sato et al. was using the length of stay as a surrogate marker of treatment success. In our study, systemic inflammatory response syndrome was present in almost all patients at some point in the disease course (95% immediate DEN group and 100% delayed DEN group). However, patients with systemic inflammatory response syndrome within 1 week of drainage underwent dDEN. This group of patients not only had a shorter length of stay in the hospital after initial stent placement but also required fewer overall necrosectomies. The authors requested additional markers of treatment success including time to clinical success and avoidance of DEN altogether. Clinical success was defined as a lack of symptoms and a decrease in collection size to less than 2 cm at which time the lumen apposing metal stent was promptly removed. The average time to clinical success was not statistically significant in the two groups (immediate DEN 40.0 days [SD 24.7] vs. delayed DEN 44.3 days [SD 24.0], p = 0.45). In addition, all patients in our study had necrosis greater than 10% and underwent at least one necrosectomy. A randomized controlled trial would further validate these results and eliminate biases innate to its retrospective design. Dr Rishi Pawa is a consultant for Boston Scientific.

Supportive treatment during the periprocedural period of endoscopic treatment for pancreatic fluid collections: a critical review of current knowledge and future perspectives.

Pancreatic fluid collections (PFCs) commonly develop as complications of acute pancreatitis and ductal disruption due to chronic pancreatitis. In the revised Atlanta classification, PFCs were classified based on the presence of necrosis and duration following the onset of acute pancreatitis. Interventions are required in cases of symptomatic pancreatic pseudocysts or walled-off necrosis (WON). In the management of these PFCs, endoscopic ultrasound-guided transluminal drainage and subsequent direct endoscopic necrosectomy for WON are increasingly utilized as less invasive treatment modalities compared to surgical debridement. To date, researchers have focused predominantly on the technical aspects of endoscopic therapy for symptomatic PFCs. Given the poor physical condition of patients receiving endoscopic treatment for PFCs, systemic support may have a substantial impact on the short- and long-term outcomes of these patients. A multidisciplinary approach is required to improve the clinical outcomes of patients with infected PFCs and their associated comorbidities. However, non-interventional support during the periprocedural period of endoscopic treatment of PFCs has not been fully discussed, and there have been considerable variations in the selection of treatment options between endoscopists and centers. To address these unmet needs in the clinical management of PFCs and promote future research to improve the clinical outcomes, we conducted a review of the literature within a multicenter consortium of expert endoscopists with specific expertise in the endoscopic treatment of PFCs. In this review, we summarize the current evidence on non-interventional supportive care (e.g., continuous lavage, medications, nutritional support, and antimicrobials) and propose potential topics for future research.