scholarly journals Efficacy and Safety of Lumen Apposing Self-Expandable Metal Stents for EUS Guided Cholecystostomy: A Meta-Analysis and Systematic Review

2018 ◽  
Vol 2018 ◽  
pp. 1-6 ◽  
Author(s):  
Nikhil R. Kalva ◽  
Vishwas Vanar ◽  
David Forcione ◽  
Matthew L. Bechtold ◽  
Srinivas Reddy Puli

Background. Patients with acute cholecystitis are treated with early cholecystectomy. A subset of patients are unfit for surgery due to comorbidities and late presentation. Prompt gall bladder drainage (GBD) with percutaneous or endoscopic approach remains a viable therapeutic option for nonoperative candidates. Endoscopic ultrasound (EUS) guided transluminal gall bladder drainage (EUS-GBD) continues to evolve as an alternative approach to percutaneous drainage. With continued refinement in stent technology, lumen apposing self-expandable metal stent (LAMS) offers several advantages. We performed a pooled analysis on the efficacy and safety of EUS-GBD with LAMS in nonoperative candidates with acute cholecystitis. Methods. Extensive English language literature search was performed in Medline, Embase, Cochrane Central, and Google Scholar using keywords “endoscopic ultrasound”, “stent”, “gallbladder”, “acute cholecystitis”, and “cholecystostomy” from Jan 2000 to Dec 2016. Fixed and random effects models were used to calculate the pooled proportions. Results. Data was extracted from 13 studies that met the inclusion criteria (n=233). Pooled proportion of technical success was 93.86% (95% CI = 90.56 to 96.49) and clinical success was 92.48% (95% CI = 88.9 to 95.42). Overall complication rate was 18.31% (95% CI = 13.49 to 23.68) and stent related complication rate was 8.16% (95% CI = 4.03 to 14.96) in the pooled percentage of patients. Pooled proportion for perforation was 6.71% (95% CI 3.65 to 10.6) and recurrent cholangitis/cholecystitis was noted in 4.05% (95% CI = 1.64 to 7.48). Publication bias calculated using Harbord-Egger bias indicator gave a value of −0.61 (95%  CI = −1.39 to 0.16, p=0.11). The Begg-Mazumdar indicator for bias gave Kendall’s tau b value of −0.42 (p≥0.05). Conclusions. EUS-GBD with LAMS is a safe and alternative treatment modality for patients needing gallbladder drainage, with acceptable intraprocedural and postprocedural complications. However, due to the limited data and lack of direct comparison with other methods, further controlled trials are necessary to estimate the overall efficacy and safety and the role of EUS-GBD with LAMS in management of nonoperative patients with acute cholecystitis.


2017 ◽  
Vol 05 (11) ◽  
pp. E1111-E1116 ◽  
Author(s):  
Raffaele Manta ◽  
Claudio Zulli ◽  
Angelo Zullo ◽  
Edoardo Forti ◽  
Alberto Tringali ◽  
...  

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.



2021 ◽  
Vol 26 (4) ◽  
pp. 248-253
Author(s):  
Gunn Huh ◽  
Tae Jun Song

Endoscopic ultrasound (EUS)-guided transmural drainage of peripancreatic fluid collection, gallbladder, bile duct, or pancreatic duct has emerged as a therapeutic option in patients with pancreatobiliary diseases. Recently, dedicated stents for EUS-guided interventions, which include lumen-apposing metal stents and modified tubular self-expanding metal stents, have been developed to improve efficacy and safety of these procedures. This article has reviewed newly developed stents for EUSguided interventions and their therapeutic outcomes.



Endoscopy ◽  
2020 ◽  
Author(s):  
Arnaldo Amato ◽  
Emanuele Sinagra ◽  
Ciro Celsa ◽  
Marco Enea ◽  
Andrea Buda ◽  
...  

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.





2010 ◽  
Vol 18 (3) ◽  
pp. 5
Author(s):  
M. CERVIGNI ◽  
G. ORTICELLI ◽  
M. BOLOGNA ◽  
F. NATALE ◽  
E. SALVATORI ◽  
...  

The aim of the study was to compare the efficacy and safety of singledose prulifloxacin vs. single-dose pefloxacin in the treatment of patients with acute uncomplicated urinary tract infections. Two hundred and thirty-one female out-patients were considered microbiologically evaluable and randomly treated with 600 mg prulifloxacin (116 patients) or 800 mg pefloxacin (115 patients). The most commonly isolated uropathogen at baseline was Escherichia coli (71.4%), followed by Proteus mirabilis (10.8%) and Klebsiella pneumoniae (7.8%). Five-seven days posttreatment, the eradication rate was 97.4% and 92.2% in the prulifloxacin and pefloxacin group, respectively. The one-tailed 95% confidence interval analysis showed the equivalence of treatments. Four weeks from treatment no relapses, reinfections or superinfections were observed. The clinical success rates were 92.2% in the prulifloxacin and 84.3% pefloxacin groups. The safety profile was very good with both drugs. The results of the study make it possible to consider prulifloxacin a possible therapeutic option in patients with acute uncomplicated UTIs.



Endoscopy ◽  
2021 ◽  
Author(s):  
Linda Y. Zhang ◽  
Rastislav Kunda ◽  
Maridi Aerts ◽  
Nouredin Messaoudi ◽  
Rishi Pawa ◽  
...  

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.



2019 ◽  
Author(s):  
joan b gornals ◽  
Manuel Perez-Miranda ◽  
Enrique Vazquez-Sequeiros ◽  
Juan Vila ◽  
Jose M Esteban ◽  
...  

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



Trials ◽  
2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Joan B. Gornals ◽  
◽  
Manuel Perez-Miranda ◽  
Enrique Vazquez-Sequeiros ◽  
Juan Vila ◽  
...  

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



Sign in / Sign up

Export Citation Format

Share Document