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

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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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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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

Endoscopy International Open ◽

10.1055/s-0043-120831 ◽

2017 ◽

Vol 05 (12) ◽

pp. E1189-E1196 ◽

Cited By ~ 5

Author(s):

Noor Bekkali ◽

Manu Nayar ◽

John Leeds ◽

Richard Charnley ◽

Matthew Huggett ◽

...

Keyword(s):

Adverse Events ◽

Delivery System ◽

Pancreatic Necrosis ◽

Clinical Success ◽

Stent Migration ◽

Metal Stents ◽

Procedure Time ◽

Metal Stent ◽

End Point ◽

Significant Difference

Abstract 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.

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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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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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A Multicenter, Prospective Study of a New Fully Covered Expandable Metal Biliary Stent for the Palliative Treatment of Malignant Bile Duct Obstruction

Gastroenterology Research and Practice ◽

10.1155/2013/642428 ◽

2013 ◽

Vol 2013 ◽

pp. 1-7 ◽

Cited By ~ 9

Author(s):

Bret T. Petersen ◽

Michel Kahaleh ◽

Richard A. Kozarek ◽

David Loren ◽

Kapil Gupta ◽

...

Keyword(s):

Adverse Events ◽

Biliary Obstruction ◽

Stent Migration ◽

Covered Stent ◽

Malignant Biliary Obstruction ◽

Metal Stents ◽

Technical Success ◽

Stent Patency ◽

Stent Occlusion ◽

Malignant Bile Duct Obstruction

Background and Study Aims. Endoscopic placement of self-expanding metal stents (SEMSs) is indicated for palliation of inoperable malignant biliary obstruction. A fully covered biliary SEMS (WallFlex Biliary RX Boston Scientific, Natick, USA) was assessed for palliation of extrahepatic malignant biliary obstruction.Patients and Methods. 58 patients were included in this prospective, multicenter series conducted under an FDA-approved IDE. Main outcome measurements included (1) absence of stent occlusion within six months or until death, whichever occurred first and (2) technical success, need for reintervention, bilirubin levels, stent patency, time to stent occlusion, and adverse events.Results. Technical success was achieved in 98% (57/58), with demonstrated acute removability in two patients. Adequate clinical palliation until completion of followup was achievedin 98% (54/55) ofevaluablepatients, with 1 reintervention due to stent obstruction after 142 days. Mean total bilirubin decreased from 8.9 mg/dL to 1.2 mg/dL at 1 month. Device-related adverse events were limited and included 2 cases of cholecystitis. One stent migrated following radiation therapy.Conclusions. The WallFlex Biliary fully covered stent yielded technically successful placement with uncomplicated acute removal where required, appropriate reduction in bilirubin levels, and low rates of stent migration and occlusion. This SEMS allows successful palliation of malignant extrahepatic biliary obstruction.

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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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Efficacy and safety of lumen apposing metal stents or self-expandable metal stents for endoscopic ultrasound-guided choledocho-duodenostomy: a systematic review and meta-analysis

Endoscopy ◽

10.1055/a-1324-7919 ◽

2020 ◽

Author(s):

Arnaldo Amato ◽

Emanuele Sinagra ◽

Ciro Celsa ◽

Marco Enea ◽

Andrea Buda ◽

...

Keyword(s):

Adverse Events ◽

Endoscopic Ultrasound ◽

Primary Outcome ◽

Clinical Success ◽

Meta Analysis ◽

Metal Stents ◽

Efficacy And Safety ◽

Technical Success ◽

Ultrasound Guided ◽

Post Procedure

BACKGROUND Endoscopic ultrasound (EUS)-guided biliary drainage is becoming an option for palliation of malignant biliary obstruction. Lumen apposing metal stents (LAMS) are replacing self-expandable metal stents (SEMS). Aim of this meta-analysis was to evaluate the efficacy and safety of LAMS or SEMS for EUS-guided choledocho-duodenostomy. METHODS A meta-analysis was performed using PRISMA protocols. Electronic databases were searched for studies on EUS-guided choledocho-duodenostomy. The primary outcome was the clinical success. Technical success, re-intervention and adverse events were secondary outcomes. We used the random effects model with the DerSimonian-Laird estimation and the results were depicted using the forest plots. Furthermore, we performed analysis of the outcomes with the data stratified by selected variables. RESULTS Overall, 31 studies (820 patients) were included. The pooled rates of clinical and technical success were 93.6% (95% CI [95%CI] 88.6-96.5%) and 94.8% (95%CI 90.2-97.3%), for LAMS , and 91.7% (95%CI 88.1-94.2) and 92.7 % (95%CI 89.9-94.9%) for SEMS, respectively. The pooled rates of adverse events were 17.1% (95%CI 12.5-22.8%) for LAMS compared to 18.3% (95% CI 14.3-23.0%) for SEMS. The pooled rates of re-intervention were 10.9% (95% CI 7.7-15.3%) for LAMS compared to 13.9% (95% CI 9.6-19.7%) for SEMS. Subgroup analyses confirmed these results. CONCLUSIONS This meta-analysis shows that LAMS and SEMS are comparable in terms of efficacy for EUS-guided choledocho-duodenostomy. The use of LAMS was associated with similar clinical and technical success, post-procedure adverse events and re-intervention rate when compared with SEMS placement. These last two points require further investigation.

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

Endoscopy International Open ◽

10.1055/a-1480-7115 ◽

2021 ◽

Vol 09 (07) ◽

pp. E1108-E1115

Author(s):

Sudhir Maharshi ◽

Shyam Sunder Sharma ◽

Sandeep Ratra ◽

Bharat Sapra ◽

Dhruv Sharma

Keyword(s):

Hydrogen Peroxide ◽

Adverse Events ◽

Clinical Success ◽

Controlled Trial ◽

Procedure Time ◽

Metal Stent ◽

Technical Success ◽

Group A ◽

Group B ◽

Walled Off Necrosis

Abstract 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 (H2O2) 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 H2O2 (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 H2O2 and BMS are equally effective in the management of WON but time to clinical success and procedure time is longer with nasocystic irrigation.

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A pilot study of novel duodenal covered self-expandable metal stent fixation

Scientific Reports ◽

10.1038/s41598-021-99265-1 ◽

2021 ◽

Vol 11 (1) ◽

Author(s):

Yasuki Hori ◽

Kazuki Hayashi ◽

Itaru Naitoh ◽

Katsuyuki Miyabe ◽

Makoto Natsume ◽

...

Keyword(s):

Pilot Study ◽

Adverse Events ◽

Gastric Outlet Obstruction ◽

Clinical Success ◽

Performance Status ◽

Outlet Obstruction ◽

Poor Performance ◽

Stent Migration ◽

Poor Performance Status ◽

Sems Placement

AbstractMigration of duodenal covered self-expandable metal stents (C-SEMSs) is the main cause of stent dysfunction in patients with malignant gastric outlet obstruction (mGOO). Because endoscopic SEMS placement is frequently selected in patients with poor performance status, we concurrently focused on the safety of the treatment. This pilot study included 15 consecutive patients with mGOO who underwent duodenal partially covered SEMS (PC-SEMS) placement with fixation using an over-the-scope-clip (OTSC). Technical feasibility, clinical success for oral intake estimated by the Gastric Outlet Obstruction Scoring System (GOOSS) score, and adverse events including stent migration were retrospectively assessed. All procedures were successful, and clinical success was achieved in 86.7% (13/15). Mean GOOSS scores were improved from 0.07 to 2.53 after the procedure (P < 0.001). Median survival time was 84 days, and all patients were followed up until death. Stent migration occurred in one case (6.7%) at day 17, which was successfully treated by removal of the migrated PC-SEMS using an enteroscope. For fixation using an OTSC, additional time required for the procedure was 8.9 ± 4.1 min and we did not observe OTSC-associated adverse events. Poor performance status was associated with clinical success (P = 0.03), but we could provide the treatment safely and reduce mGOO symptoms even in patients with poor performance status. In conclusion, duodenal PC-SEMS fixation using an OTSC is feasible for preventing stent migration in patients with mGOO including those with poor performance status.

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Feasibility of Duodenal Covered Self-Expandable Metal Stent Fixation: A Pilot Study (With Video)

10.21203/rs.3.rs-538859/v1 ◽

2021 ◽

Author(s):

Yasuki Hori ◽

Kazuki Hayashi ◽

Itaru Naitoh ◽

Katsuyuki Miyabe ◽

Makoto Natsume ◽

...

Keyword(s):

Pilot Study ◽

Adverse Events ◽

Gastric Outlet Obstruction ◽

Clinical Success ◽

Performance Status ◽

Outlet Obstruction ◽

Poor Performance ◽

Stent Migration ◽

Poor Performance Status ◽

Sems Placement

Abstract Migration of duodenal covered self-expandable metal stents (C-SEMSs) is the main cause of stent dysfunction in patients with malignant gastric outlet obstruction (mGOO). Because endoscopic SEMS placement is frequently selected in patients with poor performance status, we concurrently focused on the safety of the treatment. This pilot study included 15 consecutive patients with mGOO who underwent duodenal C-SEMS placement with fixation using an over-the-scope-clip (OTSC). Technical feasibility, clinical success for oral intake estimated by the Gastric Outlet Obstruction Scoring System (GOOSS) score, and adverse events including stent migration were assessed. All procedures were successful, and clinical success was achieved in 86.7% (13/15). Mean GOOSS scores were improved from 0.07 to 2.53 after the procedure (P < 0.001). Stent migration occurred in one case (6.7%) with no other adverse events. For fixation using an OTSC, additional time required for the procedure was 8.9 ± 4.1 minutes. Poor performance status was associated with clinical success (P = 0.03), but we could provide the treatment safely and reduce mGOO symptoms even in patients with poor performance status. In conclusion, duodenal C-SEMS fixation using an OTSC is feasible for preventing stent migration in patients with mGOO including those with poor performance status.

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