Biflanged Metal Stent Research Articles

Endoscopic ultrasound-guided drainage of pancreatic collections with dedicated metal stents: A nationwide, multicenter, propensity score-matched comparison

BackgroundThe new dedicated stents for endoscopic ultrasound (EUS)-guided transluminal drainage of peri‑pancreatic fluid collections (PFCs) demonstrated optimal efficacy and safety profiles. AimsThis study aimed to evaluate the safety, technical and clinical success, and recurrence rate of PFCs drained with Lumen Apposing Metal Stent (LAMS) or Bi-Flanged Metal Stent (BFMS). MethodsData from a multicenter series of PFCs treated with LAMS or BFMS at 30 Italian centers during a 5-year period were retrieved. The rate of adverse events (AEs), technical success, clinical success, PFC recurrence were evaluated. To overcome biases, a 1-to-1 match was created using propensity score analysis. ResultsOut of 476 patients, 386 were treated with LAMS and 90 with BFMS, with a median follow-up of 290 days (95% CI 244 to 361). Using propensity score matching, 84 patients were assigned to each group. The incidence of AEs did not differ between the two stents (13.1% versus 15.5%, p = 0.29), mainly bleeding or recurrence rate (4.7% versus 3.5%, p = 1). Technical and clinical success in the BFMS and LAMS groups were 92% versus 95% (p = 0.36) and 91% versus 94% (p = 0.64), respectively. ConclusionOur study demonstrates that LAMS and BFMS have comparable safety profiles with similar technical and clinical success rates for EUS-guided PFC drainage.

Endoscopic Ultrasound-guided Drainage of Patients With Infected Walled-off Necrosis: Which Stent to Choose?

Endoscopic ultrasound (EUS)-guided drainage is the preferred treatment of pancreatic fluid collections (PFC). However, the choice of the stent for EUS-guided drainage in critically ill PFC cases with infected walled-off necrosis (WON) and/or organ failure (OF) remains unknown. Between January 2018 and December 2019, consecutive patients with symptomatic PFC subjected to EUS-guided drainage using biflanged metal stents (BFMS) or double-pigtail plastic stents (DPPS) were compared for technical success, clinical success, duration of the procedure, need for intensive care unit stay, duration of intensive care unit stay, ventilator need, resolution of OF, the duration for resolution of OF, complications, need for salvage percutaneous drainage or surgery and mortality. A subgroup of patients having infected WON with/without OF were analyzed separately. Among 120 patients (84.6% males) with PFC (108 WON, 22 pseudocyst) who underwent EUS-guided drainage, there was no difference in outcome parameters in BFMS and DPPS groups. Among patients with WON, clinical success was significantly higher (96.2% vs. 81.8%, P=0.04), with significantly shorter hospital stay (6 vs. 10 d) and procedure duration (17.18±4.6 vs. 43.6±9.7 min, P<0.0001) in the BFMS group. Among patients with infected WON with/without OF, the clinical success was significantly higher (100% vs. 73.9%, P=0.02), and the duration of the procedure was significantly lower (16.28±4.4 vs. 44.39±10.7, P<0.0001) in BFMS compared with DPPS group. EUS-guided drainage of WON using BFMS scores over DPPS. In patients having infected WON with/without OF, BFMS may be preferred over DPPS.

Endoscopic ultrasound-guided entero-enterostomy with a hybrid biflanged metal stent for relief of afferent loop syndrome.

Watch a video of this article.

Comparative Effectiveness of Lumen-Apposing Metal Stents and Plastic Stents for the Treatment of Pancreatic Walled-Off Necrosis: A Meta-analysis.

BackgroundPlastic stents (PS), lumen-apposing metal stents (LAMS) and biflanged metal stents (BFMS) are used for initial drainage of pancreatic walled-off necrosis (WON). There are no strong evidence to support the use of LAMS/BFMS over PS, and prior systematic reviews lack comparative analyses and also lack both trial data and observational studies for WON efficacy outcomes. The aim of this study is to compare the efficacy and adverse events (AEs) in LAMS/BFMS versus PS in patients with pancreatic WON.MethodsA comprehensive search up to December 1, 2020, was performed. The primary outcome was clinical improvement after drainage. Secondary outcomes included AEs and technical failure. Pooled odds ratios (OR) with 95% confidence intervals (CI) were reported using random effects models. Heterogeneity was evaluated with the Cochrane I2 statistic. Subgroup and sensitivity analyses were performed. The quality of the evidence was assessed using Grading of Recommendations, Assessment, Development and Evaluations (GRADE).ResultsNine studies (one randomized controlled trial and eight observational) were included for the primary outcome including 493 patients treated with LAMS/BFMS and 514 with PS. LAMS/BFMS were associated with higher odds of clinical improvement compared with PS (OR 2.58; 95% CI 1.81, 3.68; I2 = 1%). This association remained robust in sensitivity analyses. The use of LAMS/BFMS was not associated with higher AEs (OR 1.22; 0.61, 2.46; I2 = 71%). There was no difference in technical failure (OR 1.06; 0.19, 6.00; I2 = 12%).ConclusionsLAMS/BFMS seem to result in better clinical outcomes compared with PS in patients with pancreatic WON, with comparable AEs and technical failure. Larger randomized controlled trials for this comparison are warranted.

Management of walled-off necrosis with nasocystic irrigation with hydrogen peroxide versus biflanged metal stent: randomized controlled trial.

Background and study aims Walled-off necrosis (WON) is a known complication of acute necrotizing pancreatitis (ANP). There is no study comparing nasocystic irrigation with hydrogen peroxide (H 2 O 2 ) versus biflanged metal stent (BMS) in the management of WON. The aim of this study was to compare the clinical efficacy of both the treatment strategies. Patients and methods This study was conducted on patients with symptomatic WON who were randomized to nasocystic irrigation with H 2 O 2 (Group A) and BMS placement (Group B). Primary outcomes were clinical and technical success while secondary outcomes were procedure time, adverse events, need for additional procedures, duration of hospitalization, and mortality. Results Fifty patients were randomized into two groups. Group A (n = 25, age 37.8 ± 17.6 years, 16 men) and Group B (n = 25, age 41.8 ± 15.2 years, 17 men). There were no significant differences in baseline characteristics between the two groups. The most common etiology of pancreatitis was alcohol, observed in 27 (54 %) patients. Technical success (100 % vs 96 %, P = 0.98), clinical success (84 % vs 76 %, P = 0.76), requirement of additional procedures (16 % vs 24 %, P = 0.70) and adverse events (4 vs 7, P = 0.06) were comparable in both the groups. The duration to clinical success (34.4 ± 12 vs 14.8 ± 10.8 days, P = 0.001) and procedure time (36 ± 15 vs 18 ± 12 minutes, P = 0.01) were longer in Group A compared to Group B. Conclusions Nasocystic irrigation with H 2 O 2 and BMS are equally effective in the management of WON but time to clinical success and procedure time is longer with nasocystic irrigation.

International, multicenter retrospective trial comparing the efficacy and safety of bi-flanged versus lumen-apposing metal stents for endoscopic drainage of walled-off pancreatic necrosis.

BackgroundTo compare fully covered bi-flanged metal stents (BFMS) and lumen-apposing metal stents (LAMS) for endoscopic ultrasound (EUS)-guided drainage/debridement of pancreatic walled-off necrosis (WON).MethodsPatients with WON managed by EUS-guided therapy were divided into those who underwent: 1) drainage using BFMS; and 2) drainage using LAMS and scheduled direct endoscopic necrosectomy (DEN). Clinical success (resolution of the WON), technical success (successful stent placement), and adverse events (AEs) were evaluated.Results387 patients underwent WON endoscopic drainage, 205 using BFMS and 182 using LAMS. The clinical success in the BFMS or LAMS groups were similar (197 [96.1%] vs. 174 [95.6%]; P=0.81). Median number of procedures required for WON resolution was significantly lower in BFMS compared to LAMS (2 vs. 3, P<0.001). Technical success for stent placement was similar in BFMS and LAMS groups (203 [99%] vs. 180 [99%], P=0.90). Procedure-related AEs were similar in the BFMS and LAMS groups (19 [9.3%] vs. 20 [10.9%], P=0.61). Stent dysfunction with occluding debris was higher in the BFMS group compared to LAMS group (21 [10.2 %] vs. 11 [5.9%], P=0.04). The migration rate was higher in the BFMS group than in the LAMS group (15 [7.3%] vs. 3 [1.6%]; P<0.001). DEN was required in 23 [11.2%] patients in the BFMS group after lack of WON resolution by conservative means.ConclusionBFMS with a “step-up approach” and LAMS with scheduled DEN are both safe and effective for EUS-guided drainage/debridement of WON.

Endoscopic retrieval through a lumen-apposing metal stent of a biflanged metal stent that had been released into a peripancreatic fluid collection.

We report a 60-year-old woman with a previous history of an endoscopically treated walled-off necrosis that developed 12 months after an 80-mm recurrent symptomatic pancreatic body pseudocyst. Drainage was attempted using a 16 × 20-mm biflanged metal stent (Nagi), but the stent was mistakenly released inside the collection. A rescue attempt was made to retrieve the stent and avoid surgical intervention.

Endoscopic Ultrasound-guided Gastroenterostomy: A Promising Alternative to Surgery.

Recently, with the advancement of techniques, endoscopic ultrasound-guided therapies have shown distinct advantages, especially in relieving benign and malignant gastric outlet obstruction (GOO), as well as in postoperative pancreaticobiliary diseases. Herein, we present five currently used approaches in endoscopic ultrasound-guided gastroenterostomy (EUS-GE) using lumenapposing biflanged metal stents (LAMS), along with several examples of LAMS-based EUS treatment of pancreaticobiliary diseases. Compared with traditional treatment methods, EUS-guided procedures have – to some degree – shown higher success rates, both technical and clinical. Moreover, EUS-guided therapies reduce the risk of multiple surgical adverse events, including delayed gastric emptying, prolonged hospital stay, increased costs, and delay in cancer treatment. Particularly in terms of postoperative pancreaticobiliary diseases, EUS-guided therapy has assumed an essential role as a treatment option in cases where traditional methods are difficult to perform. Nevertheless, EUS-guided gastrointestinal procedures are still relatively new, with some clinical failures, and additional prospective clinical trials are warranted.

10 Transmural Pancreatic Necrosectomy: A Systematic Review and Meta-Analysis on Different Endoscopic Approaches

INTRODUCTION: Acute pancreatitis is complicated by necrosis of the peripancreatic tissue in about 20% of patients. Over the past few decades, endoscopic necrosectomy (EN) is increasingly gaining traction as primary management. EN techniques are subject to rapid innovations, recently fully covered self-expanding metal stents (FCSEMS), bi-flanged metal stent (BFMS), plastic and lumen-apposing metal stents (LAMS) has taken the place of direct endoscopic necrosectomy (DEN). This study sought to determine the efficacy and safety of these approaches. METHODS: The MedLine, Embase, and Cochrane databases were systematically searched since inception till Jan 2019 and 4678 articles were retrieved. Only 59 articles deemed relevant and were analyzed using the Meta-disc. RESULTS: The weighted mean number of days in the hospital for BFMS was lowest (4.1) compared to plastic (32) and LAMS (60). The pooled proportion of successful symptoms resolution after DEN was 78.27% ± 28.15% (16.70%–94%), compared to 90 and 94% for plastic and BFMS and 100% for FCSEMS and LAMS. Radiological resolution after DEN was recorded to be 84.75%, increasing to 98%, 98.85% and 100% after plastic, FCSEMS and BFMS respectively. Overall mean complications rate was significantly high 30.46% ± (18.58%, 0–71%) in the DEN group, followed by plastic stenting 23.72% (P = 0.002). FCSEMS (16%) and BFMS (7.50%) had the lowest proportion of complications. The weighted mean recurrence of disease post-FCSEMS procedure was 23.25% and 14.75% after DEN while no recurrence occurred after BFMS. For pancreatic necrosis that did not resolve, 100% of the LAMS group, more than half of plastic and FCSEMS, and only 47% of BFMS patients had a repeat procedure. The weighted mean of mortality was highest but statistically non-significant in FCSEMS 8.62% followed by direct ETN 8.07% and BFMS patients 3.20%. CONCLUSION: EN is emerging as an increasingly popular technique, rapidly expanding the domain of therapeutic endoscopists. The highest rate of complications with DEN can be explained by the aggressive nature of procedure devoid of stentings such as puncturing the gastric or duodenal wall. Plastic, FCSEMS, and BFMS have lower procedure-related complications, and hospital stays due to small stent size and a targeted approach. The clinical and radiological resolution with these approaches were also better than DEN, but repeat procedure for stent removal or EN revision was often required. The mortality was not significantly different for different approaches.

A novel self-expanding biflanged metal stent vs tubular metal stent for EUS-guided transmural drainage of pancreatic pseudocyst: A retrospective, cohort study.

Although endoscopic ultrasound (EUS)-guided transmural drainage of pancreatic fluid collections with metal stents is generally preferred over plastic stents, its superiority among different types of metal stents has not yet been well studied. We conducted this study to compare clinical outcomes and complications of a novel self-expanding biflanged metal stent (BFMS) and a traditional-shaped tubular metal stent (TMS) in treating pancreatic pseudocyst (PPC).This was a retrospective analysis on consecutive patients with PPC underwent EUS-guided transmural drainage with either TMS or BFMS in a single tertiary center with expertise in management of complex biliary and pancreatic problems. The technical and functional success rate, reintervention, complications, and recurrence rate were evaluated.From September 2013 to January 2018, 125 patients (66.4% male, median age 47 years) underwent EUS-guided transmural drainage for PPC. Among them, 49 used TMS and 76 used BFMS. All patients met the inclusion criteria that cyst diameter was >6 cm or the distance between cyst and stomach wall was shorter than 1 cm. There was no difference in technical success (98% vs 97.4%, P = 1.0) or functional success rate (87.8% vs 92.1%, P = .54) using 2 types of metal stents. However, more procedure related complications occurred in TMS than in BFMS group. TMS group had a much higher migration rate than BFMS group (14.6% vs 0, P = .001), even though there was no significant difference in bleeding, infection, or death rate between 2 groups. With similar clinical outcomes, TMS group required more additional plastic stent placement than BFMS group for better drainage.TMS and BFMS placement can both be considered as methods of endoscopic transmural PPC drainage with equal efficacy, whereas BFMS could be preferred for fewer complications or less need of additional plastic stent placement.

Endoscopic drainage of pancreatic fluid collections by use ofanovel biflanged stent with electrocautery-enhanced deliverysystem.

Endoscopic drainage of pancreatic fluid collections by use ofanovel biflanged stent with electrocautery-enhanced deliverysystem.

French comment on article Early removal of biflanged metal stents in the management of pancreatic walled-off necrosis: a prospective study

Dans cette étude collaborative américano-indienne prospective, les auteurs se sont intéressés aux résultats de la mise en place d’endoprothèse métallique couverte à rebords bilatéraux évasés (ou prothèse métallique bi-franges-MBF) pour la prise en charge des collections nécrotiques post-pancréatites aiguës, appelées communément WON pour “Wall-Off Necrosis”.

Early removal of biflanged metal stents in the management of pancreatic walled-off necrosis: a prospective study.

Dedicated stents placed under endoscopic ultrasound (EUS) guidance have shown promise for the management of pancreatic walled-off necrosis (WON). A long duration of stent placement may increase the risk of adverse events. We prospectively evaluated the effects of (i) early removal of biflanged metal stents (BFMSs) and (ii) additional stenting of the pancreatic duct with plastic stents in patients with ductal leaks, on the risk of WON recurrence. Symptomatic patients with pancreatic WON underwent EUS-guided BFMS placement, followed by necrosectomy, when required, from Day 3. A 5 Fr plastic stent was placed in patients with ductal leak. BFMS was removed when the WON cavity had collapsed completely. Patients were followed up at 3-month intervals. BFMS placement was successful in all 88 patients. A total of 64 patients (72.7 %) underwent necrosectomy (median 3 sessions). All BFMSs were removed at a median of 3.5 weeks (range 3 - 17 weeks). Ductal disconnection and leak occurred in 53/87 (60.9 %) and 61/87 (70.1 %) patients, respectively. A 5 Fr stent was placed in 56/61 patients (91.8 %) with ductal leak. Overall, 22 patients (25.0 %) had adverse events (17 mild, 1 moderate, 3 severe, 1 fatal). Recurrence was noted in 8/88 (9.1 %) at a median follow-up of 22 months. The recurrence rate was higher in patients with ductal disconnection than in those without (13.2 % vs. 2.9 %; P = 0.08), and was similar in patients with vs. without pancreatic duct stenting (7.1 % vs. 12.9 %; P = 0.44). Seven recurrences (87.5 %) partially regressed on follow-up and did not require therapy; in one case, drainage with a plastic stent was performed. Short-term BFMS placement is an effective therapy for pancreatic WON. The majority of recurrences developed in patients with ductal disconnection and did not require therapy. Additional pancreatic duct stents probably do not influence the recurrence rate.

A comparison of outcomes between a lumen-apposing metal stent with electrocautery-enhanced delivery system and a bi-flanged metal stent for drainage of walled-off pancreatic necrosis.

Background and study aims Bi-flanged metal stents (BFMS) have shown promise in the drainage of walled-off pancreatic necrosis (WON), but their placement requires multiple steps and the use of other devices. More recently, a novel device consisting of a combined lumen-apposing metal stent (LAMS) and electrocautery-enhanced delivery system has been introduced. The aim of this study was to compare the placement and outcomes of the two devices. Patients and methods This was a retrospective review of consecutive patients undergoing endoscopic ultrasound-guided placement of BFMS or LAMS for drainage of symptomatic WON. Data from procedures between October 2012 and December 2016 were taken from a prospectively maintained database. We compared technical and clinical success, procedure time, costs, and composite end point of significant events (adverse events, stent migration, additional percutaneous drainage) between BFMS and LAMS. Results 72 consecutive patients underwent placement of BFMS (40 patients, 44 stents) or LAMS (32 patients, 33 stents). Technical success was 91 % for BFMS and 97 % for LAMS. Clinical success was 65 % vs. 78 %, respectively. Median in-room procedure time was significantly shorter in the LAMS group (45 minutes [range 30 – 80]) than in the BFMS group (62.5 minutes [range 35 – 135]; P < 0.001) and fewer direct endoscopic necrosectomies (DEN) were performed (median 1 [0 – 2.0] vs. 2 [0 – 3.7], respectively; P = 0.005). If only inpatients were considered (35 BFMS and 19 LAMS), there was no significant difference in DEN 2 (range 0 – 11) and 2 (range 0 – 8), respectively. The composite end point of 32 % vs. 24 % was not significantly different. Median procedural costs for all patients with successful stent placement for WON treatment was €4427 (range 1630 – 12 926) for BFMS vs. €3500 (range 2509 – 13 393) for LAMS ( P = 0.10). Conclusion LAMS was superior to BFMS in terms of procedure time, with comparable adverse events, success, and costs.

Technical review of endoscopic ultrasonography-guided gastroenterostomy in 2017.

Gastric outlet obstruction (GOO) can be caused by benign and malignant diseases and often leads to a reduction in patient quality of life. Lately, endoscopic ultrasonography (EUS)-guided gastroenterostomy (EUS-GE) has emerged. At the present time, there are three types of EUS-GE using lumen-apposing biflanged metal stents (LAMS): (i) direct EUS-GE; (ii) assisted EUS-GE using retrieval/dilating balloon, single balloon overtube, nasobiliary drain and ultraslim endoscope; and (iii) EUS-guided double-balloon-occluded gastrojejunostomy bypass (EPASS). Overall technical success rate is approximately 90% regardless of technique used, although this is based on two retrospective studies only. In the EPASS procedure, the success rate of the one-step procedure was higher than that of the two-step procedure (100% vs 82%). Clinical success was almost uniform when stent placement was technically successful. Although there have been no-stent induced procedural deaths, adverse events were seen in several cases. One technically failed case carried out using balloon-assisted EUS-GE was converted to laparoscopic gastrojejunostomy. Two failed cases in EPASS procedure improved with conservative treatment. In the present review, we show the feasibility and outcomes using novel EUS-GE using LAMS. Clinical prospective trials with comparison to luminal enteral stents and surgical GE are warranted.

Endoscopic ultrasound-guided drainage and sequential direct endoscopic necrosectomy for pancreatic fluid collection using a new biflanged metal stent

Background and Objectives:Endoscopic ultrasound-guided transluminal drainage (EUS-TD) and sequential direct endoscopic necrosectomy (DEN) for pancreatic fluid collections (PFCs) have been reported as a useful treatment. Recently, a new dedicated biflanged metal stent (BFMS) matched to the PFC condition has been developed. Herein, we show the prospectively evaluated clinical outcome of this new BFMS for the treatment of PFCs.Methods:EUS-TD using new stent was performed in 17 patients for PFCs (4 pancreatic pseudocysts; 13 walled-off necrosis). When clinical resolution could not be achieved within a few days after EUS-TD, DEN was performed the following day.Results:New stent was deployed successfully with a median procedure time of 16 min and with no procedure-related adverse events in all the patients. DEN (n = 5) and/or additional drainage procedure (n = 6) through the stent were achieved in all the patients in whom they were attempted (8/8). Stent dislocation during DEN was not observed in any patients, but in one patient, spontaneous stent migration was observed. Two WON patients died from pseudoaneurysm rupture occurring between the endoscopic necrosectomy sessions and from multiple organ failure although hemostasis was achieved by coil embolization. The PFCs in the other 15 patients completely resolved.Conclusions:The new BFMS is technically feasible and safe for the treatment of PFCs.

Prospective evaluation of a new biflanged metal stent for the treatment of pancreatic fluid collections (with videos)

EUS-guided transluminal drainage (EUS-TD) and sequential direct endoscopic necrosectomy (DEN) for pancreatic fluid collections (PFCs) by using a dedicated biflanged metal stent (BFMS) has been reported as a useful alternative to using plastic stents or a conventional metal stent. However, current dedicated BFMSs have limitations. Recently, a new BFMS with solidly constructed biflanges and various stent lengths matched to the PFC condition has been developed. Herein, we prospectively evaluated this new BFMS for the treatment of PFCs. From July 2015 to July 2016, EUS-TD by using the new BFMS was performed in 12 patients for PFCs (4patients with pancreatic pseudocysts, 8 patients with walled-off necrosis). When clinical resolution could not be achieved, DEN was performed the following day. The stent was deployed successfully with a median procedure time of 16 minutes (range 11-24 minutes) and with no procedure-related adverse events in any patients (12/12, 100%). DEN via the stent was achieved in all patients in whom they were attempted (4/4,100%). Spontaneous stent migration or stent dislocation during DEN was not observed in any patients. Two WON patients died from spontaneous pseudoaneurysm rupture and multiple organ failure. The PFCs in the other 10 patients completely resolved, and later the stent was removed with no difficulty in 9 patients after a median time of 48 days (range 30-180 days). The new BFMS is technically feasible and safe for the treatment of PFCs. (Clinical trial registration number: UMIN000021347.).

Endoscopic “step-up approach” using a dedicated biflanged metal stent reduces the need for direct necrosectomy in walled-off necrosis (with videos)

EUS-guided drainage using plastic stents may be inadequate for treatment of walled-off necrosis (WON). Recent studies report variable outcomes even when using covered metal stents. The aim of this study was to evaluate the efficacy of a dedicated covered biflanged metal stent (BFMS) when adopting an endoscopic "step-up approach" for drainage of symptomatic WON. We retrospectively evaluated consecutive patients with symptomatic WON who underwent EUS-guided drainage using BFMSs over a 3-year period. Reassessment was done between 48 and 72 hours for resolution. Endoscopic reinterventions were tailored in nonresponders in a stepwise manner. Step 1 encompassed declogging the blocked lumen of the BFMS. In step 2, a nasocystic tube was placed via BFMSs with intermittent irrigation. Step 3 involved direct endoscopic necrosectomy (DEN). BFMSs were removed between 4 and 8 weeks of follow-up. The main outcome measures were technical success, clinical success, adverse events, and need for DEN. Two hundred five WON patients underwent EUS-guided drainage using BFMSs. Technical success was achieved in 203 patients (99%). Periprocedure adverse events occurred in 8 patients (bleeding in 6, perforation in 2). Clinical success with BFMSs alone was seen in 153 patients (74.6%). Reintervention adopting the step-up approach was required in 49 patients (23.9%). Incremental success was achieved in 10 patients with step 1, 16 patients with step 2, and 19 patients with step 3. Overall clinical success was achieved in 198 patients (96.5%), with DEN required in 9.2%. Four patients failed treatment and required surgery (2) or percutaneous drainage (2). The endoscopic step-up approach using BFMSs was safe, effective, and yielded successful outcomes in most patients, reducing the need for DEN.

Surgical removal of the migrated biflanged metal stent following the EUS-guided transluminal drainage for pancreatic pseudocyst

Surgical removal of the migrated biflanged metal stent following the EUS-guided transluminal drainage for pancreatic pseudocyst

Clinical evaluation of endoscopic ultrasonography-guided drainage using a novel flared-type biflanged metal stent for pancreatic fluid collection.

Background and Objectives:Endoscopic ultrasonography (EUS)-guided transluminal drainage for pancreatic fluid collections (PFCs) has become the standard therapy worldwide as a minimally invasive therapy compared with surgical drainage. Recently, a novel flared-type biflanged metal stent (BFMS) designed specifically for the treatment of PFCs has been developed. The aim of this study was to retrospectively assess the feasibility and safety of EUS-guided drainage and direct endoscopic necrosectomy (DEN) for PFCs using the novel flared-type BFMS.Patients and Methods:Twenty-one patients were treated by EUS-guided drainage using a flared-type BFMS for PFCs (pancreatic pseudocyst, 2 patients; walled-off necrosis, 19 patients).Results:The present study showed a technical success rate of 100%, a final clinical success rate of 100%, a procedure-related adverse event (AE) rate of 0%, an early AE rate of 28.6% (moderate and severe AE rate of 9.5%), a mortality rate of 0%, and a recurrence rate of 9.5%. DEN (mean, 2.3 sessions) was required in 38% of the patients.Conclusion:The present study clarified that the EUS-guided drainage using the flared-type BFMS is an effective and safe treatment approach for PFCs. Further studies using randomized controlled multicenter trials are warranted.