scholarly journals 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

2017 ◽  
Vol 05 (12) ◽  
pp. E1189-E1196 ◽  
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.

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

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.

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

2017 ◽  
Vol 05 (09) ◽  
pp. E861-E867 ◽  
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.

scholarly journals What is the Impact of the Proportion of Solid Necrotic Content on the Number of Necrosectomies during EUS-Guided Drainage using Lumen-Apposing Metallic Stents of Pancreatic Walled-off Necrosis ?

2020 ◽  
Vol 29 (4) ◽  
pp. 623-628
Author(s):  
Andrada Seicean ◽  
Cristina Pojoga ◽  
Ofelia Mostean ◽  
Sorana Bolboaca ◽  
Madalina Ilie ◽  
...  
Keyword(s):  
Pancreatic Necrosis ◽  
Clinical Success ◽  
Metal Stents ◽  
Metal Stent ◽  
Endoscopic Necrosectomy ◽  
Medical Centers ◽  
One Step ◽  
Walled Off Necrosis ◽  
The Impact

Background and Aims: The fully-covered, lumen apposing metal stents are designed for one step placement, facilitating the direct endoscopic necrosectomy into the walled-off pancreatic necrosis. However, the prediction of the number of necrosectomy sessions in these patients is not known. This study evaluated the association between the proportion of solid necrotic material inside walled-off necrosis, as assessed during the endosonography placement of a lumen apposing metal stent, and the number of necrosectomies subsequently required. Methods: Patients from three tertiary medical centers with symptomatic walled off pancreatic necrosis (pain, infection, gastric/biliary obstruction) at more than 4 weeks after onset of acute pancreatitis were retrospectively analysed. Proportion of solid necrotic debris was estimated during endosonography procedure of lumen apposing metal stents placement. Necrosectomy was performed when obstruction or inflammation occurred subsequently. Lumen apposing metal stents were removed after clearance of necrotic content. Results: In 46 patients with successful lumen apposing metal stents placement, necrosectomy was performed in 39 patients (72.78%). Performance of 3 or more necrosectomies was significantly associated with more than 50% pancreatic necrosis (p=0.032), but not with walled-off pancreatic necrosis size or location. Necrotic infection during lumen apposing metal stents stenting was associated with hypoalbuminemia, but not with necrosectomy requirement. Clinical success after a median follow-up of 13.37 months was 87%. Conclusions: Walled-off pancreatic necrosis with more than 50% solid necrotic content were associated with more necrosectomy procedures, requiering longer endoscopy time, intravenous sedations, and higher costs.

scholarly journals EUS-guided gallbladder drainage: a learning curve modified by technical progress

2020 ◽  
Vol 08 (01) ◽  
pp. E92-E96 ◽  
Author(s):  
Amy Tyberg ◽  
Kopal Jha ◽  
Shawn Shah ◽  
Prashant Kedia ◽  
Monica Gaidhane ◽  
...  
Keyword(s):  
Adverse Events ◽  
Learning Curve ◽  
Clinical Success ◽  
Plastic Stents ◽  
Metal Stents ◽  
P Value ◽  
Procedure Time ◽  
Gallbladder Drainage ◽  
Post Procedure

Abstract Introduction Endoscopic ultrasound-guided gallbladder drainage (EUS-GBD) is an efficacious and safe option for patients who cannot undergo cholecystectomy. It is a technically challenging procedure, requiring skills in EUS, and ERCP. The aim of this study was to define the learning curve for EUS-GBD. Patients and methods Consecutive patients undergoing EUS-GBD by a single operator were included from a prospective registry over 5 years. Demographics, procedure information, post-procedure follow-up data, and information on adverse events were collected. Non-linear regression and CUSUM analyses were conducted for the learning curve. Clinical success was defined as resolution of cholecystitis post-procedure. Results Forty-eight patients were included (58 % male, mean age 76 years). Twenty patients (42 %) had malignant cholecystitis. Most patients had lumen-apposing metal stents (LAMS) (15 mm, n = 29, 60 %; 10 mm, n = 8, 7 %). The remaining patients had FCSEMS (n = 9, 19 %) or plastic stents alone (n = 2, 4 %). Clinical success was achieved in 36 (86 %) of patients. Of the remaining 12, 7 were lost to follow-up and 5 had persistent cholecystitis. 9 patients (19 %) had adverse events including bleeding (n = 4), liver abscesses (n = 2), and hypotension. Two patients passed away post-procedure. Median procedure time was 41 minutes (range 16 – 121 min), with the 41-minute time occurring during the 19th procedure. Procedure durations further reduced, with the last 10 procedures being 20 minutes or under (nonlinear regression p value P < 0.0001). Conclusion Endoscopists experienced in EUS-GBD are expected to achieve a reduction in procedure time over successive cases, with efficiency reached at 41 minutes and a learning rate of 19 cases. Continued improvement is demonstrated with additional experience

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

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.

scholarly journals Feasibility and Safety of Endoluminal Radiofrequency Ablation as a Rescue Treatment for Bilateral Metal Stent Obstruction Due to Tumor Ingrowth in the Hilum: A Pilot Study

2021 ◽  
Vol 10 (5) ◽  
pp. 952
Author(s):  
Hoonsub So ◽  
Chi Hyuk Oh ◽  
Tae Jun Song ◽  
Hyun Woo Lee ◽  
Jun Seong Hwang ◽  
...  
Keyword(s):  
Radiofrequency Ablation ◽  
Bile Duct ◽  
Adverse Events ◽  
Bile Duct Obstruction ◽  
Metal Stents ◽  
Metal Stent ◽  
Duct Obstruction ◽  
Tumor Ingrowth ◽  
Malignant Bile Duct Obstruction ◽  
Hilar Bile Duct

Background. Radiofrequency ablation (RFA) is a palliative method known for its application in the endoscopic treatment of malignant bile duct obstruction. It may be a useful rescue method for metal stent malfunction caused by tumor ingrowth. This study aimed to examine the feasibility and safety of endoluminal RFA for occluded bilateral hilar metal stents due to tumor ingrowth in patients with malignant hilar bile duct obstruction. Methods: From March 2016 to June 2018, 11 patients with unresectable malignant hilar bile duct stricture with occluded bilateral hilar metal stents due to tumor ingrowth were enrolled. Endoluminal RFA was performed through a novel temperature-controlled catheter at a setting of 7 W power for 120 s with a target temperature of 80 °C via endoscopic retrograde cholangiopancreatography (ERCP). The patients’ demographics, clinical outcomes, and adverse events were investigated. Results: The median age was 64 (interquartile range, 54–72) years. All RFA procedures were successful. Clinical success was achieved in eight patients (72.7%). During the follow-up, eight patients (72.7%) showed stent dysfunction, and the median patency after RFA was 50 days (95% confidence interval (CI): 34–not available (NA)). All stent dysfunctions were successfully managed with ERCP. Ten patients died, and the median overall survival was 289 days (95% CI, 107–NA) from RFA to death. There was one case of mild abdominal pain after the procedure without serious adverse events. Conclusions: As a rescue therapy for occluded bilateral hilar metal stents due to tumor ingrowth, endoluminal RFA seemed to be safe and useful in selected patients.

scholarly journals Direct endoscopic necrosectomy in infected pancreatic necrosis using lumen-apposing metal stents: Early intervention does not compromise outcome

2021 ◽  
Vol 09 (03) ◽  
pp. E490-E495
Author(s):  
David Albers ◽  
Alexander Meining ◽  
Alexander Hann ◽  
Younan Kabara Ayoub ◽  
Brigitte Schumacher
Keyword(s):  
Early Intervention ◽  
Pancreatic Necrosis ◽  
Early Stage ◽  
Clinical Success ◽  
Infected Pancreatic Necrosis ◽  
Metal Stents ◽  
Optimal Timing ◽  
Stent Insertion ◽  
Endoscopic Necrosectomy ◽  
Walled Off Necrosis

Abstract Background and study aims Infection of pancreatic necrosis is a dreaded complication requiring an intervention. Nevertheless, the optimal timing of the first intervention is unclear, and consensus data are sparse. This retrospective two-center study evaluated direct endoscopic necrosectomy using lumen apposing metal stents in case of proven or suspected infected pancreatic necrosis in an early stage of the disease. Patients and methods Forty-nine patients with infected pancreatic necrosis were included. Sequent direct endoscopic necrosectomies after lumen apposing metal stent insertion (LAMS) were performed until the resolution of necrosis. In all patients, the first endoscopic intervention was performed within the first 30 days after first proof of pancreatic necrosis. Primary outcome parameters were inflammatory activity, days spent in the Intensive Care Unit (ICU), and mortality. Results The patient cohort received median 4 necrosectomies (3–5) after a median of 7 days (3–11) after first proof of pancreatic necrosis. Technical and clinical success were achieved in 98.3 % and 87.8 %, respectively; the mortality rate was 8.2 %. The median C-reactive protein level decreased from 241 mg/L (182.9–288.9) before the intervention to a median of 23.3 mg/L (18–60) after therapy. The median time period in the ICU was 5 days (3–9). Conclusions Early endoscopic therapy in the form of direct endoscopic necrosectomy after LAMS placement within the first 30 days after proof of pancreatic necrosis is effective and does not result in poor outcome. Our retrospective data suggest that early intervention before walled-off necrosis is formed is tenable when it is essential due to the patient's clinical deterioration.

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

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.

Comparison of the Efficacy, Safety and Tolerability of Azithromycin and Co-Amoxiclav in the Treatment of Acute Periapical Abscesses

1998 ◽  
Vol 26 (5) ◽  
pp. 257-265 ◽  
Author(s):  
CF Adriaenssen
Keyword(s):  
Soft Tissue ◽  
Adverse Events ◽  
Comparative Study ◽  
Clinical Success ◽  
Point Scale ◽  
Once Daily ◽  
Significant Difference ◽  
Before And After ◽  
Dental Practices

The activity, safety and tolerability of the azalide azithromycin were compared with those of co-amoxiclav in the treatment of acute periapical abscesses in adults in an open, randomized, multicentre comparative study. Patients of either sex, recruited from 106 dental practices in Belgium, were aged between 18 and 75 years and had acute periapical abscesses not requiring drainage, confirmed by radiology. Azithromycin was administered as a 500-mg tablet orally once daily for 3 days ( n = 150) and co-amoxiclav as a 625-mg capsule three times daily, for 5–10 days ( n = 153). Both before and after treatment, masticatory pain, percussion pain, headache, and oedema and redness of soft tissue were graded on a four-point scale. Overall clinical success (cure plus improvement) was seen in 131/144 (91%) evaluable patients receiving azithromycin and in 142/148 (96%) receiving co-amoxiclav (difference not significant). There was no significant difference between the two groups in the incidence or severity of adverse events or in the number of discontinuations because of adverse events.

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

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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