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

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

Endoscopy International Open ◽

10.1055/a-0828-7630 ◽

2019 ◽

Vol 07 (03) ◽

pp. E347-E354 ◽

Cited By ~ 15

Author(s):

Yen-I Chen ◽

Juliana Yang ◽

Shai Friedland ◽

Ian Holmes ◽

Ryan Law ◽

...

Keyword(s):

Clinical Success ◽

Plastic Stents ◽

Metal Stents ◽

Success Rates ◽

Technical Success ◽

Transmural Drainage ◽

International Multicenter Study ◽

Walled Off Necrosis ◽

International Multicenter

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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Are Lumen-Apposing Metal Stents More Effective Than Plastic Stents for the Management of Pancreatic Fluid Collections: An Updated Systematic Review and Meta-analysis

Gastroenterology Research and Practice ◽

10.1155/2020/4952721 ◽

2020 ◽

Vol 2020 ◽

pp. 1-13

Author(s):

Shali Tan ◽

Chunyu Zhong ◽

Yutang Ren ◽

Xujuan Luo ◽

Jin Xu ◽

...

Keyword(s):

Adverse Events ◽

Clinical Success ◽

Meta Analysis ◽

Plastic Stents ◽

Metal Stents ◽

Efficacy And Safety ◽

Technical Success ◽

Pancreatic Fluid Collections ◽

Pancreatic Fluid ◽

Fluid Collections

Background and Aims. Recently, a new type of metal stent, named lumen-apposing metal stents (LAMS), has been designed to manage pancreatic fluid collections (PFC), and a few studies have reported its efficacy and safety. Therefore, we conducted this meta-analysis to investigate the role of LAMS for PFC. Methods. We searched the studies from PubMed, MEDLINE, Embase, and Cochrane databases from inception to May 2019. We extracted the data and analyzed the technical success, clinical success, and adverse events of LAMS to evaluate its efficacy and safety. Results. Twenty studies with 1534 patients were included. The pooled technical success, clinical success, and adverse event rates of LAMS for PFC were 96.2% (95% confidence interval (CI): 94.6%-97.4%), 86.8% (95% CI: 83.1%-89.8%), and 20.7% (95% CI: 16.1%-26.1%), respectively. Eight studies including 875 patients compared the clinical outcomes of LAMS with plastic stents. The pooled risk ratio (RR) of technical success and clinical success for LAMS and plastic stent was 1.01 (95% CI: 0.98-1.04, P=0.62) and 1.06 (95% CI: 1.01-1.12, P=0.03), respectively. As for the overall adverse events, the pooled RR was 1.51 (95% CI: 0.67-3.44, P=0.32). Conclusions. Our current study revealed that LAMS has advantages over plastic stents for PFC, with higher clinical success rate and lower complication rate of infection and occlusion.

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Novel 15-mm-long lumen-apposing metal stent for endoscopic ultrasound-guided drainage of pancreatic fluid collections located ≥10 mm from the luminal wall

Endoscopy ◽

10.1055/a-1682-7095 ◽

2021 ◽

Author(s):

Linda Y. Zhang ◽

Rastislav Kunda ◽

Maridi Aerts ◽

Nouredin Messaoudi ◽

Rishi Pawa ◽

...

Keyword(s):

Endoscopic Ultrasound ◽

Clinical Symptoms ◽

Clinical Success ◽

Duodenal Wall ◽

Metal Stents ◽

Pancreatic Fluid Collections ◽

Pancreatic Fluid ◽

Maximal Diameter ◽

International Multicenter Study ◽

Fluid Collections

Abstract Background Endoscopic ultrasound (EUS)-guided drainage of pancreatic fluid collections (PFCs) by cautery-enhanced lumen-apposing metal stents (LAMS) has largely been limited to collections located < 10 mm from the luminal wall. We present outcomes of the use of a novel 15-mm-long cautery-enhanced LAMS for drainage of PFCs located ≥ 10 mm away. Methods This international, multicenter study analyzed all adults with PFCs located ≥ 10 mm from the luminal wall who were treated by EUS-guided drainage using the 15-mm-long cautery-enhanced LAMS. The primary outcome was technical success. Secondary outcomes included clinical success (decrease in PFC size by ≥ 50 % at 30 days and resolution of clinical symptoms without surgical intervention), complications, and recurrence. Results 35 patients (median age 57 years; interquartile range [IQR] 47–64 years; 49 % male) underwent novel LAMS placement for drainage of PFCs (26 walled-off necrosis, 9 pseudocysts), measuring 85 mm (IQR 64–117) maximal diameter and located 11.8 mm (IQR 10–12.3; range 10–14) from the gastric/duodenal wall. Technical and clinical success were high (both 97 %), with recurrence in one patient (3 %) at a median follow-up of 123 days (58–236). Three complications occurred (9 %; one mild, two moderate). Conclusions The 15-mm-long cautery-enhanced LAMS was feasible and safe for drainage of PFCs located 10–14 mm from the luminal wall.

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Endoscopic treatment of Crohn-related strictures with a self-expandable stent compared with balloon dilation: a prospective, randomised, controlled study

BMJ Open Gastroenterology ◽

10.1136/bmjgast-2021-000612 ◽

2021 ◽

Vol 8 (1) ◽

pp. e000612

Author(s):

Per Hedenström ◽

Per-Ove Stotzer

Keyword(s):

Crohn’S Disease ◽

Crohn's Disease ◽

Adverse Events ◽

Endoscopic Treatment ◽

Clinical Success ◽

Balloon Dilation ◽

Controlled Study ◽

Metal Stents ◽

Technical Success ◽

Increased Risk

ObjectiveFibrotic strictures in the gastrointestinal tract are frequent in Crohn’s disease. Endoscopic dilation is a standard treatment. However, recurrence is common after dilation and there are complications such as bleeding or perforation. Endoscopic treatment using self-expandable metal stents has shown diverging results. The aim of this study was to evaluate the outcome of endoscopic treatment with a self-expandable stent in ileocecal Crohn’s disease.Design/methodPatients with Crohn’s disease and a symptomatic ileocecal stricture were eligible for prospective, consecutive inclusion in a single-centre setting. Patients were randomised to treatment with either 18 mm balloon dilatation (GroupDIL) or stenting (GroupSTENT) using a 20 mm diameter, partially covered Hanarostent NCN. Patients were followed for a minimum of 24 months postendoscopy. Outcomes were technical success, adverse events and clinical success (defined as no need for repeated interventions).ResultsThirteen patients (GroupDIL n=6; GroupSTENT=7) were included with twelve patients (GroupDIL n=5; GroupSTENT=7) being eligible for complete follow-up. Technical success was achieved in all cases. Adverse events were border-line significantly more common in the GroupSTENT: 4/7 (57%) (pain: n=3; pain and rectal bleeding: n=1) compared with the GroupDIL: 0/5 (0%), p=0.08, which resulted in preterm termination of the study. The clinical success rate was GroupSTENT: 6/7 (86%) vs GroupDIL: 1/5 (20%), p=0.07.ConclusionPatients with strictures related to Crohn’s disease may benefit from treatment with self-expandable metal stents rather than dilatation. However, there seems to be an increased risk for patient pain after stenting, which has to be considered and handled.Trail registration numberThe study was registered at Clinical Trials (NCT04718493).

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The Effect of Peroral Endoscopic Myotomy in Achalasia Patients with Prior Endoscopic Intervention: A Systematic Review and Meta-Analysis

Digestive Surgery ◽

10.1159/000512627 ◽

2021 ◽

pp. 1-13

Author(s):

Chunyu Zhong ◽

Bowen Ni ◽

Sixiu Liu ◽

Shali Tan ◽

Muhan Lü ◽

...

Keyword(s):

Adverse Events ◽

Randomized Clinical Trials ◽

Clinical Success ◽

Meta Analysis ◽

Clinical Success Rate ◽

Peroral Endoscopic Myotomy ◽

Technical Success ◽

Endoscopic Intervention ◽

Eckardt Score ◽

Endoscopic Myotomy

Background: Peroral endoscopic myotomy (POEM) has been reported to be effective in achalasia patients with prior failed endoscopic intervention (PFI). We performed this meta-analysis to compare and summarize the clinical outcome of POEM in patients with or without prior endoscopic intervention. Method: We searched relevant studies published up to March 2020. Meta-analysis for technical success, clinical success, Eckardt score, lower esophageal sphincter (LES) pressure, clinical reflux, and adverse event were conducted based on a random-effects model. Results: Eight studies enrolling 1,797 patients who underwent POEM were enrolled, including 1,128 naïve achalasia patients and 669 patients with PFI. In the PFI group, the pooled estimated rate of technical success was 97.7% (95% confidence interval [CI], 95.8–98.8%), the pooled clinical success rate was 91.0% (95% CI, 88.0–93.4%), and the pooled adverse events rate was 23.5% (95% CI, 10.6–44.1%). The Eckardt score significantly decreased by 5.95 points (95% CI, 5.50–6.40, p < 0.00001) and the LES pressure significantly reduced by 19.74 mm Hg (95% CI, 14.10–25.39, p < 0.00001) in the PFI group. There were no difference in the technical success, clinical success, and adverse events rate between the treatment-naïve group and PFI group, with a risk ratio of 1.0 (95% CI, 0.99–1.01, p = 0.89), 1.02 (95% CI, 0.98–1.06, p = 0.36), and 0.88 (95% CI, 0.67–1.16, p = 0.38), respectively. Conclusions: POEM is an effective and safe treatment for achalasia patients with prior endoscopic intervention. Randomized clinical trials are needed to further verify the efficiency and safety of the POEM in those patients.

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Safety and efficacy of coaxial lumen-apposing metal stents in the management of refractory gastrointestinal luminal strictures: a multicenter study

Endoscopy International Open ◽

10.1055/s-0043-114665 ◽

2017 ◽

Vol 05 (09) ◽

pp. E861-E867 ◽

Cited By ~ 12

Author(s):

Fateh Bazerbachi ◽

Jason Heffley ◽

Barham Abu Dayyeh ◽

Jose Nieto ◽

Eric Vargas ◽

...

Keyword(s):

Adverse Events ◽

Clinical Success ◽

Stent Migration ◽

Metal Stents ◽

Technical Success ◽

Novel Therapy ◽

Safety And Efficacy ◽

Anastomotic Strictures ◽

The Mean

Abstract Background and aims Benign gastrointestinal (GI) strictures are often refractory to standard endoscopic interventions. Fully covered coaxial lumen-apposing metal stents (LAMS) have emerged as a novel therapy for these strictures. The aim of this study was to evaluate the safety and efficacy of LAMS for refractory GI strictures. Patients and methods A retrospective analysis was performed for patients who underwent LAMS placement for benign luminal strictures in three US centers between January 2014 and December 2016. The primary outcomes were technical success and initial clinical success of LAMS placement. Secondary outcomes were stent migration, rate of re-intervention, and adverse events. Results A total of 49 patients underwent 56 LAMS placement procedures. Previous treatment had failed in 39 patients (79.6 %), and anastomotic strictures were the indication in 77.6 % (38/49), with the most common site being gastrojejunal (34.7 % [17/49]). Technical success was achieved in all procedures and initial clinical success was achieved in 96.4 % of all procedures (54/56). Patient initial clinical success was 95.9 % (47/49). Stent migration occurred in 17.9 % of procedures, and was more likely to occur at sites in the lower GI tract (P = 0.02). The mean stent dwell time was 100.6 days, and the mean follow-up was 169.8 days. Minor adverse events, not requiring hospitalization, occurred in 33.9 % of procedures, including subsequent stricture progression (10.7 %). In cases where LAMS were removed, mean follow-up time was 102.2 days. The re-intervention rate was 75 % at 300 days follow-up after stent removal. Of the LAMS placed at anastomotic strictures, 36.4 % required re-intervention, with approximately two-thirds of these re-interventions requiring placement of a new stent or surgery. Conclusion LAMS placement was successful for the management of refractory GI strictures, with good technical and initial clinical success rates. However, re-intervention rates after LAMS removal were high, and many strictures were not resolved by an extended period of stenting with these coaxial stents. LAMS placement offers additional therapeutic options and in selected cases might be considered a destination therapy for patients with recalcitrant benign strictures.

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EUS-guided biliary drainage versus ERCP for first-line palliation of malignant distal biliary obstruction: A systematic review and meta-analysis

Scientific Reports ◽

10.1038/s41598-019-52993-x ◽

2019 ◽

Vol 9 (1) ◽

Cited By ~ 11

Author(s):

Sung Yong Han ◽

Seon-Ok Kim ◽

Hoonsub So ◽

Euisoo Shin ◽

Dong Uk Kim ◽

...

Keyword(s):

Adverse Events ◽

Success Rate ◽

Subgroup Analysis ◽

Biliary Obstruction ◽

Randomized Trials ◽

Clinical Success ◽

Clinical Success Rate ◽

Technical Success ◽

First Line ◽

Duodenal Invasion

Abstract Endoscopic retrograde cholangiopancreatography (ERCP) with transpapillary metal stenting is the standard palliation method for malignant distal biliary obstruction (MDBO); however, post-ERCP pancreatitis are not uncommon. Endoscopic ultrasonography-guided biliary drainage (EUS-BD) with transmural metal stenting has emerged as an option for primary palliation of MDBO. We compared the efficacy and safety of these procedures as first-line MDBO treatment. We searched for relevant English-language articles in PubMed, Embase, and Cochrane databases. The outcomes of interest were technical success, clinical success, adverse events, stent patency, reintervention rates, and procedure time. Subgroup analysis was performed for patients without duodenal invasion (eg, endoscopically accessible papilla; EUS-choledochoduodenostomy [CDS] vs. ERCP). Ten studies (3 randomized trials and 7 retrospective studies) with 756 patients were included. The cumulative technical and clinical success rates were high for both procedures (EUS-BD: 94.8% [294/310] and 93.8% [286/305], ERCP: 96.5% [386/400] and 95.7% [377/394]). The cumulative adverse event rates were 16.3% (54/331) for EUS-BD and 18.3% (78/425) for ERCP. In subgroup analysis for patients without duodenal invasion, EUS-CDS showed similar cumulative technical and clinical success rate with ERCP (technical success rate, EUS-CDS vs. ERCP: 94.2% [146/155] vs. 97.8% [237/242]; clinical success rate, EUS-CDS vs. ERCP: 94.2% [145/154] vs. 93.0% [225/242]). The cumulative rate of adverse events for EUS-CDS and ERCP was also comparable (15.5% [24/155] for EUS-CDS and 18.6% [45/242] for ERCP). As first-line palliation of MDBO, EUS-BD was similar to ERCP in technical and clinical success and safety; however, larger randomized trials comparing EUS-CDS and ERCP in this setting with endoscopically accessible papilla may be required.

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International multicenter comparative trial of endoscopic ultrasonography-guided gastroenterostomy versus surgical gastrojejunostomy for the treatment of malignant gastric outlet obstruction

Endoscopy International Open ◽

10.1055/s-0043-101695 ◽

2017 ◽

Vol 05 (04) ◽

pp. E275-E281 ◽

Cited By ~ 53

Author(s):

Mouen Khashab ◽

Majidah Bukhari ◽

Todd Baron ◽

Jose Nieto ◽

Mohamad El Zein ◽

...

Keyword(s):

Success Rate ◽

Gastric Outlet Obstruction ◽

Clinical Success ◽

Outlet Obstruction ◽

Clinical Success Rate ◽

Comparative Trial ◽

Metal Stents ◽

Technical Success ◽

Malignant Gastric Outlet Obstruction ◽

The Mean

Abstract Background and study aims EUS-guided gastroenterostomy (EUS-GE) is a novel procedure that potentially offers long-lasting luminal patency without the risk of tumor ingrowth/overgrowth. This study compared the clinical success, technical success, adverse events (AEs), length of hospital stay (LOHS) and symptom recurrence in EUS-GE versus SGJ. Methods This was a multicenter international retrospective comparative study of EUS-GE and SGJ in patients with malignant gastric outlet obstruction (GOO) who underwent either EUS-GE or SGJ. EUS-GE was performed using lumen apposing metal stents. Results A total of 93 patients with malignant GOO treated with either EUS-GE (n = 30) or SGJ (n = 63) were identified. Peritoneal carcinomatosis was present in 13 (43 %) patients in the EUS-GE group and 7 (11 %) patients in the SGJ group (P < 0.001). Although the technical success rate was significantly higher in the SGJ group as compared to the EUS-GE group (100 % vs. 87 %, P = 0.009), the clinical success rate was not different (90 % vs. 87 %, P = 0.18, OR 0.8, 95 %CI 0.44 – 7.07). The rate of AEs was lower in the EUS-GE group, but the difference was not statistically significant (16 % vs 25 %, P = 0.3). The mean LOHS was similar in the EUS-GE group compared to SGJ (P = 0.35). The rate of recurrent GOO was not different between the two groups (3 % vs. 14 %, P = 0.08). Similarly, the mean time to reintervention was similar (88 days vs. 121 days, P = 0.83). Conclusions EUS-GE is associated with equivalent efficacy and safety as compared to surgical GJ. This is the first comparative trial between both techniques and suggests EUS-GE as a non-inferior but less invasive alter to surgery.

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Management of Leaks Following Laparoscopic Sleeve Gastrectomy Using Specifically Designed Large Covered Metal Stents

Reviews on Recent Clinical Trials ◽

10.2174/1574887116666210204142417 ◽

2021 ◽

Vol 16 ◽

Author(s):

Carmelo Luigiano ◽

Milena Di Leo ◽

Leonardo Henry Eusebi ◽

Matteo Barabino ◽

Enrico De Nicola ◽

...

Keyword(s):

Sleeve Gastrectomy ◽

Adverse Events ◽

Laparoscopic Sleeve Gastrectomy ◽

Clinical Success ◽

Major Complication ◽

Stent Migration ◽

Metal Stents ◽

Technical Success ◽

Previous Surgery ◽

Frequent Complication

Background: Leaks are the major complication associated with laparoscopic sleeve gastrectomy. Objective: To assess the efficacy and safety of specifically designed large covered metal stents for the management post-laparoscopic sleeve gastrectomy leaks. Results: Twenty-one patients (67% females, mean age 45 years) were included in the study and a total of 26 stents were placed. Technical success of stent placement was achieved in all cases (100%). Clinical success was observed in 85.5% of patients. Stent related adverse events occurred in 9 patients (43%), with stent migration as most frequent complication (33%). Adverse events were more frequently observed in patients who had undergone bariatric surgery prior to laparoscopic sleeve gastrectomy compared to patients without previous surgery (83% vs 27%, p=0.018). Conclusions: Placement of specifically designed covered metal stents appears to be an effective and safe therapeutic approach for post-laparoscopic sleeve gastrectomy leaks. Stent migration can be a frequent complication.

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