Lumen apposing metal stents are superior to plastic stents in pancreatic walled-off necrosis: a large international multicenter study

Abstract Background and study aims The use of lumen apposing metal stents (LAMS) during EUS-guided transmural drainage (EUS-TD) of pancreatic walled-off necrosis (WON) has gained popularity. Data supporting their use in WON over plastic stents (PS), however, remain scarce. The aim of this study was to compare the clinical efficacy of LAMS (Axios, Boston Scientific) with PS in WON. Patients and methods This was a multicenter, retrospective study involving 14 centers. Consecutive patients who underwent EUS-TD of WON (2012 – 2016) were included. The primary end point was clinical success defined as WON size ≤ 3 cm within a 6-month period without need for percutaneous drainage (PCD) or surgery. Results A total of 189 patients (mean age 55.2 ± 15.6 years, 34.9 % female) were included (102 LAMS and 87 PS). Technical success rates were similar: 100 % in LAMS and 98.9 % in PS (P = 0.28). Clinical success was attained in 80.4 % of LAMS and 57.5 % of PS (P = 0.001). Rate of PCD was similar (13.7 % LAMS vs. 16.3 % PS, P = 0.62), while PS was associated with a greater need for surgery (16.1 % PS vs. 5.6 % LAMS, P = 0.02). Adverse events (AEs) were observed in 9.8 % of LAMS and 10.3 % of PS (P = 0.90) and were rated as severe in 2.0 % and 6.9 %, respectively (P = 0.93). After excluding patients with < 6 months follow-up, the rate of WON recurrence following initial clinical success was greater with PS (22.9 % PS vs. 5.6 % LAMS, P = 0.04). Conclusions When compared to PS, LAMS in WON is associated with higher clinical success, shorter procedure time, lower need for surgery, and lower rate of recurrence.

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Lumen-apposing stents versus plastic stents in the management of pancreatic pseudocysts: a large, comparative, international, multicenter study

Endoscopy ◽

10.1055/a-0759-1353 ◽

2018 ◽

Vol 51 (11) ◽

pp. 1035-1043 ◽

Cited By ~ 6

Author(s):

Juliana Yang ◽

Yen-I Chen ◽

Shai Friedland ◽

Ian Holmes ◽

Christopher Paiji ◽

...

Keyword(s):

Adverse Events ◽

Clinical Success ◽

Length Of Hospital Stay ◽

Plastic Stents ◽

Pancreatic Pseudocysts ◽

Technical Success ◽

Pancreatic Fluid ◽

International Multicenter Study ◽

Fluid Collections

Abstract Background Larger caliber lumen-apposing stents (LAMSs) have been increasingly used in the management of pancreatic fluid collections, specifically when solid debris is present; however, their advantages over smaller caliber plastic stents in the management of pancreatic pseudocysts are unclear. The aim of this study was to investigate the safety and efficacy of LAMS specifically in the management of pancreatic pseudocysts compared with double-pigtail plastic stents (DPPSs). Methods We performed a multicenter, international, retrospective study between January 2012 and August 2016. A total of 205 patients with a diagnosis of pancreatic pseudocysts were included, 80 patients received LAMSs and 125 received DPPSs. Measured outcomes included clinical success, technical success, adverse events, stent dysfunction, pancreatic pseudocyst recurrence, and need for surgery. Results Technical success was similar between the LAMS and the DPPS groups (97.5 % vs. 99.2 %; P = 0.32). Clinical success was higher for LAMSs than for DPPSs (96.3 % vs. 87.2 %; P = 0.03). While the need for surgery was similar between the two groups (1.3 % vs. 4.9 %, respectively; P = 0.17), the use of percutaneous drainage was significantly lower in the LAMS group (1.3 % vs. 8.8 %; P = 0.03). At 6-month follow-up, the recurrence rate was similar between the groups (6.7 % vs 18.8 %, respectively; P = 0.12). The rate of adverse events was significantly higher in the DPPS group (7.5 % vs. 17.6 %; P = 0.04). There was no difference in post-procedure mean length of hospital stay (6.3 days [standard deviation 27.9] vs. 3.7 days [5.7]; P = 0.31). Conclusion When compared to DPPSs, LAMSs are a safe, feasible, and effective modality for the treatment of pancreatic pseudocysts and are associated with a higher rate of clinical success, shorter procedure time, less need for percutaneous interventions, and a lower overall rate of adverse events.

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Safety and efficacy of the use of lumen-apposing metal stents in the management of postoperative fluid collections: a large, international, multicenter study

Endoscopy ◽

10.1055/a-0924-5591 ◽

2019 ◽

Vol 51 (08) ◽

pp. 715-721

Author(s):

Juliana Yang ◽

Jeremy H. Kaplan ◽

Amrita Sethi ◽

Enad Dawod ◽

Reem Z. Sharaiha ◽

...

Keyword(s):

Adverse Events ◽

Clinical Success ◽

Clinical Success Rate ◽

Metal Stents ◽

Technical Success ◽

Common Etiology ◽

Feasible Alternative ◽

International Multicenter Study ◽

Fluid Collections ◽

International Multicenter

Abstract Background Multiple studies have examined the use of lumen-apposing metal stents (LAMSs) for the drainage of peripancreatic fluid collections. Data on the use of LAMSs for postoperative fluid collections (POFCs) are scarce. POFCs may lead to severe complications without appropriate treatment. We aimed to study the outcomes (technical success, clinical success, rate/severity of adverse events, length of stay, recurrence) of the use of LAMSs for the drainage of POFCs. Methods This international, multicenter, retrospective study involved 19 centers between January 2012 and October 2017. The primary outcome was clinical success. Secondary outcomes included technical success and rate/severity of adverse events using the ASGE lexicon. Results A total of 62 patients were included during the study period. The most common etiology of the POFCs was distal pancreatectomy (46.8 %). The mean (standard deviation) diameter was 84.5 mm (30.7 mm). The most common indication for drainage was infection (48.4 %) and transgastric drainage was the most common approach (82.3 %). Technical success was achieved in 60/62 patients (96.8 %) and clinical success in 57/62 patients (91.9 %) during a median (interquartile range) follow-up of 231 days (90 – 300 days). Percutaneous drainage was needed in 8.1 % of patients. Adverse events occurred intraoperatively in 1/62 patients (1.6 %) and postoperatively in 7/62 (11.3 %). There was no procedure-related mortality. Conclusion This is the largest study on the use of LAMSs for POFCs. It suggests good clinical efficacy and safety of this approach. The use of LAMSs in the management of POFCs is a feasible alternative to percutaneous and surgical drainage.

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Fully covered self-expanding metal stents for refractory pancreatic duct strictures in symptomatic chronic pancreatitis, US experience

Endoscopy International Open ◽

10.1055/a-0858-2169 ◽

2019 ◽

Vol 07 (11) ◽

pp. E1419-E1423 ◽

Cited By ~ 3

Author(s):

Reem Z. Sharaiha ◽

Aleksey Novikov ◽

Kristen Weaver ◽

Pawan Marfatia ◽

Jonathan M. Buscaglia ◽

...

Keyword(s):

Chronic Pancreatitis ◽

Success Rate ◽

Pancreatic Duct ◽

Clinical Success ◽

Tertiary Care ◽

Plastic Stents ◽

Metal Stents ◽

Technical Success ◽

Self Expanding Metal Stents

Abstract Background and study aims Fully covered self-expanding metal stents (FCSEMS) have been used to treat refractory pancreatic duct strictures. We aimed to evaluate the feasibility, safety, and efficacy of FCSEMS in chronic pancreatitis with refractory pancreatic duct strictures. Patients and methods This was a retrospective multicenter cases series of patients who underwent endoscopic retrograde cholangiopancreatography (ERCP) with FCSEMS placement in the main pancreatic duct (MPD) at five tertiary care centers between February 2010 and June 2016. Primary endpoints were technical success, clinical success, and procedure-related morbidity. Secondary endpoints were pain relief at the end of follow-up and resolution of the pancreatic stricture on ERCP. Results Thirty-three patients with previously drained stents, 76 % of whom were male, underwent ERCP with FCSEMS placement. Mean duration of follow-up was 14 months. All of the patients had prior therapy. The technical success rate for FCSEMS placement was 100 % (n = 33) and the clinical success rate was 93 % (was n = 31). Stents were removed after a median duration of 14.4 weeks. After stent removal, the diameter of the narrowest MPD stricture had increased significantly from 1 mm to 4.5 mm (P < 0.001). There was a statistically significant improvement on the Visual Analogue Scale (VAS) from a median of 8.5 to 2.5. At the end of the study, (n = 27) 87.1 % of patients reported significant pain reduction with reduced narcotic use. Conclusion FCSEMS appeared to be a feasible, safe, and potentially effective Intervention in patients who had not responded to endoscopic therapy with plastic stents.

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Rheolytic Thrombectomy Using AngioJet ZelanteDVT Catheter or Solent Omni Catheter for Treatment of Patients with Proximal Vein Thrombosis

10.21203/rs.3.rs-1073588/v1 ◽

2021 ◽

Author(s):

Maofeng Gong ◽

Guanqi Fu ◽

Zhengli Liu ◽

Yangyi Zhou ◽

Jie Kong ◽

...

Keyword(s):

Clinical Success ◽

Successful Outcome ◽

Success Rates ◽

Technical Success ◽

Bleeding Events ◽

Vein Thrombosis ◽

Rheolytic Thrombectomy ◽

Deep Vein ◽

Clinical Characteristic

Abstract Purpose The present study aimed to investigate the preliminary safety and efficacy of rheolytic thrombectomy (RT) using AngioJet ZelanteDVT catheter or Solent Omni catheter for acute proximal deep vein thrombosis (DVT).Material and Methods We conducted a retrospective review of 40 patients who treated by AngioJet RT divided into ZelanteDVT group (n=17) and Solent group (n=23) from January 2019 to January 2021. Data of demographics, clinical characteristic, technical success, clinical success, complications, and early follow-up were analysed.Results No significant differences regarding demographics were detected (all p >.05). The technical success rates were both 100%. ZelanteDVT group had a shorter duration time of RT and a higher primary RT success than those of Solent group (all p <.05), and percentage of adjunctive CDT was 29.4% in ZelanteDVT group, significantly lower than that was 79.3% in Solent group (p =.010). The successful outcome for ZelanteDVT group and Solent group were 100% (17/17) and 95.7% (22/23), both high in the two groups (p >.05). Except for transient macroscopic hemoglobinuria occurred in all patients at the first 24 hours post-RT, none suffered other procedure-related adverse events or major complications in both groups. Minor complications presented as bleeding events occurred in 21.7% (5/23) patients of Solent group, and one (5.9%) patient in Zelante DVT group (p >.05). At 6-month, the frequency of PTS was 5.9% (1/17) in ZelanteDVT group compared with 17.4% (4/ 23) in Solent group (p >.05).Conclusion Both catheters are safe and effective for the management of patients with proximal DVT, leading to improved clinical outcomes with low complication. Zelante-DVT catheter offered more powerful thrombectomy over Solent catheter, allowing for faster extraction of the DVT with shorter run time and lower adjunctive CDT.

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

Endoscopy ◽

10.1055/s-0043-123575 ◽

2017 ◽

Vol 50 (06) ◽

pp. 597-605 ◽

Cited By ~ 12

Author(s):

Vinay Dhir ◽

Douglas Adler ◽

Ankit Dalal ◽

Nitin Aherrao ◽

Rahul Shah ◽

...

Keyword(s):

Adverse Events ◽

Pancreatic Duct ◽

Recurrence Rate ◽

Plastic Stents ◽

Metal Stents ◽

Plastic Stent ◽

Early Removal ◽

Pancreatic Duct Stenting ◽

Walled Off Necrosis

Abstract Background and study aims 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. Patients and methods 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. Results 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. Conclusions 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.

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Comparative Randomized Multicenter Study Of Plastic Vs. Self-expanding Metal Stents In The Endoscopic Ultrasound-guided Drainage Of Walled-off Pancreatic Necrosis

10.21203/rs.2.16362/v1 ◽

2019 ◽

Author(s):

joan b gornals ◽

Manuel Perez-Miranda ◽

Enrique Vazquez-Sequeiros ◽

Juan Vila ◽

Jose M Esteban ◽

...

Keyword(s):

Endoscopic Ultrasound ◽

Clinical Success ◽

Fluid Collection ◽

Plastic Stents ◽

Metal Stents ◽

Controlled Clinical Trial ◽

Pancreatic Fluid Collection ◽

Pancreatic Fluid ◽

Tertiary Hospitals ◽

Walled Off Necrosis

Abstract Background: It seems that the appearance of lumen-apposing metal stents (LAMS), are displacing the role of plastic stents in the therapy of pancreatic fluid collection as walled-off necrosis (WON). To date there is no quality of evidence to recommend LAMS as the standard treatment in management of WON. The theoretical benefit of LAMS over PLASTIC stents, need to be proved.Methods/design: This is a multicenter prospective study, superiority, randomized controlled clinical trial by parallel groups, without masking. One hundred fourteen patients with WON will be Endoscopic ultrasound (EUS)-guided transmural drained in 9 tertiary hospitals in Spain and will be randomized to the LAMS or PLASTIC stent group. The primary endpoint is to assess the short-term (4 weeks) clinical success determined by the reduction of the collection (to <50% or < 5cm in size), along with clinical improvement. Secondary endpoints: the long-term (4 months) clinical success (total resolution or 5cm); the procedure’s duration, the level of difficulty, safety and recurrences.Discussion: The PROMETHEUS trial has been designed to response if LAMS are superior over PLASTIC stents in the EUS-guided transmural drainage of WON. Trial registration: ClinicalTrials.gov, NCT03100578. Registered on April 4, 2017. https://clinicaltrials.gov/ct2/home

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Multicenter study of plastic vs. self-expanding metal stents in endoscopic ultrasound-guided drainage of walled-off pancreatic necrosis – PROMETHEUS: a randomized controlled trial protocol

Trials ◽

10.1186/s13063-019-3988-x ◽

2019 ◽

Vol 20 (1) ◽

Author(s):

Joan B. Gornals ◽

◽

Manuel Perez-Miranda ◽

Enrique Vazquez-Sequeiros ◽

Juan Vila ◽

...

Keyword(s):

Endoscopic Ultrasound ◽

Clinical Success ◽

Controlled Trial ◽

Fluid Collection ◽

Plastic Stents ◽

Metal Stents ◽

Pancreatic Fluid Collection ◽

Randomized Controlled ◽

Link Type ◽

Walled Off Necrosis

Abstract Background It seems that lumen-apposing metal stents (LAMS) are displacing plastic stents in the therapy of pancreatic-fluid collection in walled-off necrosis (WON). To date, there is no quality of evidence to recommend LAMS as the standard treatment in the management of WON. The theoretical benefit of LAMS over plastic stents needs to be proven. Methods/design This is a randomized controlled, multicenter, prospective clinical trial with two parallel groups, without masking. One-hundred and fourteen patients with WON will undergo endoscopic ultrasound (EUS)-guided transmural draining in nine tertiary hospitals in Spain and will be randomized to the LAMS or plastic-stent group. The primary endpoint is the short-term (4 weeks) clinical success determined by the reduction of the collection (to < 50% or < 5 cm in size), along with clinical improvement. Secondary endpoints: long-term (4 months) clinical success (total resolution or 5 cm), procedure duration, level of difficulty, safety, and recurrences. Discussion The PROMETHEUS trial has been designed to determine whether LAMS are superior to plastic stents in EUS-guided transmural drainage of WON. Trial registration ClinicalTrials.gov, ID: NCT03100578. Registered on 4 April 2017. https://clinicaltrials.gov/ct2/home

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Endoscopic ultrasound-guided gallbladder drainage for acute cholecystitis with a silicone-covered nitinol short bilaterally flared stent: a case series

Endoscopy International Open ◽

10.1055/s-0043-118659 ◽

2017 ◽

Vol 05 (11) ◽

pp. E1111-E1116 ◽

Cited By ~ 2

Author(s):

Raffaele Manta ◽

Claudio Zulli ◽

Angelo Zullo ◽

Edoardo Forti ◽

Alberto Tringali ◽

...

Keyword(s):

Acute Cholecystitis ◽

Endoscopic Ultrasound ◽

Clinical Success ◽

Symptom Relief ◽

Case Series ◽

Metal Stents ◽

Success Rates ◽

Gallbladder Drainage ◽

First Case

Abstract Background and study aim Gallbladder drainage in patients with cholecystitis who are unsuitable for surgery may be performed by endoscopic ultrasound (EUS)-guided placement of specifically designed fully covered metal stents. We describe the first case series of patients treated with a silicone-covered nitinol stent with bilateral anchor flanges. Patients and methods Data from consecutive patients with acute cholecystitis who were deemed unsuitable candidates for surgery were collected. The stent placement procedure was performed in two tertiary endoscopy centers by four experienced endoscopists. Technical and clinical success rates, as well as adverse events and clinical outcome at follow-up, were assessed. Results EUS-guided drainage for cholecystitis was performed in 16 patients (mean age 84 years; nine males). Technical and clinical success rates were 100 % (16/16) and 94 % (15/16), respectively; an early failure due to stone impaction occurred in the remaining case and required placement of a new stent. Symptom relief occurred in 11/15 cases (73 %) within 1 day, and within 2 days in the remaining 4 patients. Bleeding occurred in two patients (13 %): in one patient intraprocedural bleeding was successfully stopped during endoscopy; and delayed bleeding occurred in one patient requiring arterial embolization for catastrophic bleeding (patient died 10 days later). No cases of cholecystitis recurrence or biliary obstruction were observed during a median follow-up of 112 days (range 49 – 180 days). Conclusions Our data showed that EUS-guided gallbladder drainage with a specially designed stent is feasible and successful in patients with acute cholecystitis who are unfit for surgery.

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Clinical evaluation of physician-controlled guidewire manipulation during endoscopic ultrasound-guided hepaticogastrostomy (with video)

Endoscopy International Open ◽

10.1055/a-1336-3132 ◽

2021 ◽

Vol 09 (03) ◽

pp. E395-E400

Author(s):

Kyohei Nishiguchi ◽

Takeshi Ogura ◽

Nobu Nishioka ◽

Saori Ueno ◽

Atsushi Okuda ◽

...

Keyword(s):

Bile Duct ◽

Success Rate ◽

Endoscopic Ultrasound ◽

Intrahepatic Bile Duct ◽

Plastic Stents ◽

Metal Stents ◽

Success Rates ◽

Technical Success ◽

Technical Success Rate ◽

Tract Dilation

Abstract Background and study aims Endoscopic ultrasound (EUS)-guided hepaticogastrostomy (HGS) may be most complex because of the EUS-guided biliary drainage procedure and variations in the course of the intrahepatic bile duct compared with the common bile duct (CBD). Appropriate guidewire insertion is essential. Physician-controlled guidewire manipulation (PCGW) might improve technical success rates of bile duct cannulation. The present study aimed to determine the technical feasibility and safety of PCGW during EUS-HGS. Patients and methods A total of 122 consecutive patients who were scheduled to undergo EUS-HGS between October 2017 and April 2019 were prospectively registered. The primary endpoint was the technical success rate of guidewire insertion into the CBD or hepatic hilum. Guidewire insertion was considered to have failed if the HGS assistant failed to achieve manipulation. Results The intrahepatic bile duct was successfully punctured in 120 of 122 patients. During guidewire insertion by the HGS assistant, guidewire fracture was observed in one patient. The guidewire was successfully inserted into the biliary tract and manipulated by the HGS assistant in 96 patients. PCGW was thus attempted for the remaining 23 patients. The guidewire was inserted by PCGW in all 23 patients, improving the technical success rate for guidewire insertion from 80 % to 100 %. After tract dilation, we deployed covered metal stents and plastic stents in 117 and two patients, respectively. The overall technical success rate for EUS-HGS was 97.5 % (119/122). Adverse events comprising bile peritonitis or leakage developed in five patients. Conclusion PCGW might contribute to improving the success rate of EUS-HGS.

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