CLINICAL EFFICACY AND ADVERSE EVENTS OF FULLY COVERED SELF-EXPANDABLE METAL STENTS (FC-SEMS) IN PANCREATOBILIARY STENOSIS

2018 ◽  
Author(s):  
C Huertas ◽  
M Figa ◽  
M Hombrados ◽  
H Uchima ◽  
D Busquets ◽  
...  
2021 ◽  
Vol 10 (5) ◽  
pp. 952
Author(s):  
Hoonsub So ◽  
Chi Hyuk Oh ◽  
Tae Jun Song ◽  
Hyun Woo Lee ◽  
Jun Seong Hwang ◽  
...  

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.


2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Sang Hoon Lee ◽  
Yeon Suk Kim ◽  
Eui Joo Kim ◽  
Hee Seung Lee ◽  
Jeong Youp Park ◽  
...  

AbstractChronic pancreatitis (CP) related main pancreatic duct (MPD) stricture has been a challenge for endoscopists. Fully covered self-expandable metal stents (FC-SEMS) has been tried in CP patients, but the efficacy and safety are still controversial. Thus, we aim to compare the long-term clinical efficacy of FC-SEMS vs. plastic stent placement in persistent MPD strictures secondary to CP. Between 2007 and 2018, 80 chronic pancreatitis patients (58 males, median age 49 years), who underwent endoscopic placement of FC-SEMS (n = 26) and plastic stent (n = 54) for persistent MPD strictures after at least 3 months of initial single plastic stenting, were retrospectively analyzed during a median follow-up duration of 33.7 months. As a result, MPD stricture resolution rate was statistically higher in FC-SEMS group (87.0% vs. 42.0%, p < 0.001). Although immediate complications occurred similarly (38.5% vs. 37.0%, p = 0.902), spontaneous migration (26.9%) and de novo strictures (23.1%) were pronounced delayed complications in FC-SEMS group. Pain relief during follow-up was significantly higher in FC-SEMS group (76.9% vs. 53.7%, p = 0.046). The total procedure cost was similar in both groups ($1,455.6 vs. $1,596.9, p = 0.486). In comparison with plastic stent, FC-SEMS placement for persistent MPD strictures had favorable long-term clinical efficacy, with its typical complications like spontaneous migration and de novo strictures.


2020 ◽  
Vol 91 (4) ◽  
pp. 205-210
Author(s):  
Gian Maria Busetto ◽  
Francesco Del Giudice ◽  
Daniele D'Agostino ◽  
Daniele Romagnoli ◽  
Andrea Minervini ◽  
...  

Background: Combination therapy with 5 alpha-reductase inhibitor (5-ARI) and alpha-blocker can be considered as a gold standard intervention for medical management of lower urinary tract symptoms related to benign prostatic hyperplasia (LUTS/BPH). On the other hand, 5-ARI monotherapy and in particular Finasteride alone is currently getting focus of attention especially due to lack of systematic reviews investigating efficacy outcomes and/or adverse events associated. Objectives: Aim of the present critical review was to analyze current knowledge of clinical efficacy and incidence of adverse events associated with 5-ARI treatment for LUTS/BPH. Materials and methods: A systematic review of clinical trials of the literature of the past 20 years was performed using database from PubMed, Cochrane Collaboration and Embase. A total of 8821 patients were included in this study and inclusion criteria for studies selection were: data from randomized clinical trials (RCTs) focusing their attention on the clinical role of Finasteride monotherapy for symptomatic BPH. Parameters of research included prostate specific antigen (PSA), prostate volume (PV), International Prostate Symptom Score (IPPS), postvoid residual urine (PVR), voiding symptoms of IPSS (voiding IPSS), maximum urinary flow rate (Qmax), and adverse events (AEs). Results: Overall 12 original articles were included and critically evaluated. Sample sizes of patient actively treated with finasteride varied from 13 to 1524 cases analyzed in a single study. Follow-up after treatments ranged from 3 to 54 months. The effect of finasteride in reducing prostate volume (PV) was moderate (standardized mean difference (SMD) effect between 0.5 to 0.8 for all trials evaluable) while the effect on IPSS score and Qmax was considered significant (SMD in the 0.2 to 0.5 variation range). No severe AEs and/or psychiatric disorders were retrieved among the studies. Sexual health dysfunctions were significantly influenced by finasteride therapy when compared with placebo treated patients. Conclusions: Although significant clinical benefits of finasteride monotherapy were demonstrated, the effective size of the available reports included in the analysis is limited. Additional head-to-head studies would be needed to re-evaluate clinical efficacy and safety of 5-ARI in combination or not with alpha blockers.


2021 ◽  
Vol 36 (Supplement_1) ◽  
Author(s):  
Jianhua Dong ◽  
Li Huang ◽  
Chuan Li ◽  
Ling Kong ◽  
Lixuan Huang ◽  
...  

Abstract Background and Aims The Study delves into the clinical efficacy and advantages of centrifugal double filtration plasmapheresis on severe lupus nephritis (LN) by comparing it with membranous double filtration plasmapheresis (DFPP). Method A retrospective analysis was performed on 56 patients who were diagnosed with severe LN and had received DFPP treatment from May 2016 and January 2020. Of them, 38 were given centrifugal DFPP and had their plasma centrifuged in a blood cell separator, and 18 were given membranous DFPP and had their plasma centrifuged in an MPS07 plasma separator. An EC20W plasma component separator was used as the secondary filter to reprocess the separated plasma of all of them. The two DFPPs were compared for differences in clinical efficacy, vascular access, dosage of anticoagulant, treatment cost and adverse events in patients with severe LN. Results Of the 56 severe LN patients (including 43 females and 13 males), the median of age of onset was 29 years old, the SLEDAI (Systemic Lupus Erythematosus Disease Activity Index) was 18.6±6.0 points and the serum creatinine was 402(294,553) umol/L, and all patients had acute kidney injury and 51 of them (91.1%) required renal replacement therapy (RRT). A total of 142 DFPPs were performed, including 97 centrifugal DFPPs and 45 membranous DFPPs. After treatment and at Month 3 of follow-up visit, patients in both the centrifugal DFPP group and the membranous DFPP group had ANA, AdsDNA titer, quantitative urinary protein, urinary red blood cell count and serum creatinine significantly dropped and hemoglobin significantly increased over those before treatment, the differences in which between the two groups, however, were not statistically significant. The centrifugal DFPP group had a more significant drop in complements C3 and C4 after treatment. Comparison of the data before and after a single DFPP treatment showed that the membranous DFPP group had a more significantly longer prothrombin time, but there were no differences in partial prothrombin time, fibrinogen and platelet change between the two groups. At Month 3 of follow-up visit, 31 of the 51 RRT patients (60.8%) (including 34 given centrifugal DFPP and 17 given membranous DFPP) were released from dialysis, including 23 given centrifugal DFPP and 8 given membranous DFPP. In the membranous DFPP group, all patients had the vascular access built via the central venous catheter, while in the centrifugal DFPP group, 6 patients (15.8%) had the vascular access built by puncturing into the artery or vein. The dosage of the anticoagulant, the low molecular weight heparin, to the centrifugal DFPP group was significantly lower than that to the membranous DFPP group (1174±243 vs 4106±399IU, P&lt;0.001), and in the centrifugal DFPP group, 29 patients (76.3%) were given 4% citric acid alone for anti-coagulation. No blood coagulation occurred. In terms of treatment consumables, the membranous DFPP group had a significantly higher cost than the centrifugal DFPP group (RMB4340.2±237.0 vs 5677.0±0.0, P&lt;0.001). Two patients (4.4%) in the membranous DFPP group developed skin ectasis, epistaxis or aggravated alveolar hemorrhage after treatment, and four patients (4.1%) in the centrifugal DFPP group developed perioral numbness, numbness in distal extremities or tetany during treatment, which was alleviated after calcium supplementation. Conclusion Centrifugal DFPP differed little from membranous DFPP in clinical efficacy in severe LN patients, but had lower anti-coagulation requirements, cost less on treatment consumables, and caused no severe adverse events, so it can be used as an important means to treat severe LN.


2020 ◽  
Vol V (I) ◽  
pp. 39-48
Author(s):  
Syeda Komal Fatima ◽  
Ameena Tur Rasool ◽  
Ayesha Sabir ◽  
Gul Shahnaz

COVID-19 has posed a great threat to mankind, there is a dire need to introduce a vaccine to combat this global pandemic. Several vaccines are underway to complete their phase 3 clinical trials. This article highlights events surrounding the ongoing clinical trials of vaccines effective against COVID-19, and different procedures and formalities the vaccine will have to endure to get EUA. Clinical trials are discussed stepwise along with the clinical endpoint desired at the end of these trials. In line with antimicrobial resistance, vaccine resistance has also emerged in this era and needs focused consideration, and the probability of development of resistance in these vaccines is discussed. This article specifically covers the latest research reporting clinical efficacy, safety profile, and adverse events following the administration of doses to patients and concerns regarding the rushed approval of vaccines. Four vaccines have been discussed in detail; BNT162b2, mRNA-1273, Sputnik V, ChAdOx1.


Author(s):  
Ying Zhang ◽  
Xu Hao ◽  
Kelu Hou ◽  
Lei Hu ◽  
Jingyuan Shang ◽  
...  

Aims: To assess the impact of cytochrome P450 (CYP) 2C19 polymorphisms on the clinical efficacy and safety of voriconazole. Methods: We systematically searched PubMed, EMBASE, CENTRAL, ClinicalTrials.gov, and three Chinese databases from their inception to March 18, 2021 using a predefined search algorithm to identify relevant studies. Studies that reported voriconazole-treated patients and information on CYP2C19 polymorphisms were included. The efficacy outcome was success rate. The safety outcomes included overall adverse events, hepatotoxicity and neurotoxicity. Results: A total of 20 studies were included. Intermediate metabolizers (IMs) and Poor metabolizers (PMs) were associated with increased success rates compared with normal metabolizers (NMs) (risk ratio (RR): 1.18, 95% confidence interval (CI): 1.03~1.34, I2=0%, p=0.02; RR: 1.28, 95%CI: 1.06~1.54, I2=0%, p=0.01). PMs were at increased risk of overall adverse events in comparison with NMs and IMs (RR: 2.18, 95%CI: 1.35~3.53, I2=0%, p=0.001; RR: 1.80, 95% CI: 1.23~2.64, I2=0%, p=0.003). PMs demonstrated a trend towards an increased incidence of hepatotoxicity when compared with NMs (RR: 1.60, 95%CI: 0.94~2.74, I2=27%, p=0.08), although there was no statistically significant difference. In addition, there was no significant association between CYP2C19 polymorphisms and neurotoxicity. Conclusions: IMs and PMs were at a significant higher success rate in comparison with NMs. PMs were significantly associated with an increased incidence of all adverse events compared with NMs and IMs. Researches are expected to further confirm these findings. Additionally, the relationship between hepatotoxicity and CYP2C19 polymorphisms deservers clinical attention.


2019 ◽  
Vol 12 ◽  
pp. 263177451984634 ◽  
Author(s):  
Katsuya Kitamura ◽  
Akira Yamamiya ◽  
Yu Ishii ◽  
Yuta Mitsui ◽  
Hitoshi Yoshida

Aim: To investigate outcomes of endoscopic bilateral side-by-side placement across the papilla using 10-mm-diameter uncovered self-expandable metal stents for unresectable malignant hilar biliary obstruction. Methods: We retrospectively analyzed 23 patients who underwent endoscopic biliary uncovered self-expandable metal stent placement for unresectable malignant hilar biliary obstruction between January 2015 and September 2016 at our institution. We performed endoscopic side-by-side placement across the papilla using 10-mm-diameter longer-model uncovered self-expandable metal stents. Outcomes included the technical and functional success rates, recurrent biliary obstruction rate, time to recurrent biliary obstruction, reintervention rate, and incidence of adverse events other than recurrent biliary obstruction. Results: Of the 23 patients, 10 with malignant hilar biliary obstruction underwent endoscopic side-by-side uncovered self-expandable metal stent placement across the papilla (median age, 83 years; 6 men). The locations of malignant hilar biliary obstruction were Bismuth types II ( n = 3), III ( n = 3), and IV ( n = 4). The median common bile duct diameter was 8 mm. The technical and functional success rates were 100% and 80%, respectively. Seven patients (70%) developed recurrent biliary obstruction because of stent occlusions, including early hemobilia in two patients and late tumor ingrowth in five patients. The median time to recurrent biliary obstruction was 66 (95% confidence interval: 29–483) days. Six patients (60%) required reintervention, and 1 (10%) underwent transcatheter arterial embolization for right hepatic arterial pseudoaneurysm. Early adverse events other than recurrent biliary obstruction occurred in four patients and late adverse event in one patient. Conclusion: Endoscopic side-by-side placement across the papilla using 10-mm-diameter uncovered self-expandable metal stents was technically feasible for unresectable malignant hilar biliary obstruction; however, it might be better to avoid this method for patients with malignant hilar biliary obstruction because of high recurrent biliary obstruction rate and shorter time to recurrent biliary obstruction.


Endoscopy ◽  
2020 ◽  
Vol 52 (06) ◽  
pp. 474-482
Author(s):  
Pierre H. Deprez ◽  
Tom G. Moreels ◽  
Tarik Aouattah ◽  
Hubert Piessevaux ◽  
Enrique Pérez-Cuadrado-Robles

Background Self-expanding metal stents (SEMSs) are recommended in unresectable distal malignant biliary obstruction. However, problems with dysfunction and migration of these stents are not negligible. We aimed to investigate the effectiveness and safety of a new 12-Fr plastic stent. Methods In an observational, prospective study, all consecutive patients who underwent biliary stenting with the 12-Fr stent were considered (index group). Referent groups were a historical cohort, matched by sex, etiology, and metastatic status, including patients with 10-Fr plastic stents and with fully covered and uncovered SEMSs (FCSEMSs and UCSEMSs). Outcomes were stent patency, recurrent biliary obstruction (RBO), technical success, 30-day mortality and adverse events. A post-procedure examination of removed stents was done. Results 72 patients (median age 66, range 32 – 94 years, 50 % men) were included (24 index, 48 referents). There were no differences in median stent patency time (P = 0.684). RBO was significantly lower with the 12-Fr compared with the 10-Fr profile stent (50 % vs. 81.3 %, P = 0.04), but no difference was found compared with the FCSEMSs (50 % vs. 43.8 %, P = 0.698). Technical success was 100 %, with no differences in 30-day mortality P = 0.105). The adverse events rate was 4.2 % for both groups (index n = 1, referents n = 2). Of 11 removed 12-Fr plastic stents suspected to be dysfunctional, 7 (64 %) were still patent. Conclusions This new 12-Fr plastic stent could be an effective and cheaper alternative to SEMSs in distal malignant biliary obstruction.


Endoscopy ◽  
2017 ◽  
Vol 50 (06) ◽  
pp. 597-605 ◽  
Author(s):  
Vinay Dhir ◽  
Douglas Adler ◽  
Ankit Dalal ◽  
Nitin Aherrao ◽  
Rahul Shah ◽  
...  

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.


1995 ◽  
Vol 3 (1) ◽  
pp. 28-33 ◽  
Author(s):  
Ashwin Chatwani ◽  
Mark Martens ◽  
David A. Grimes ◽  
Molly Chatterjee ◽  
Melvin Noah ◽  
...  

Objective: The purpose of this study was to compare the clinical efficacy and safety of cefmetazole given by IV push with that of parenterally administered cefoxitin for the treatment of endometritis following cesarean delivery.Methods: In a single-blind, multicenter, prospective, randomized study, 355 patients with endometritis after cesarean delivery were enrolled and received medication. Administered was either cefmetazole sodium, 2 g by IV push over 1 min q 8 h, or cefoxitin sodium, 2 g IV q 6 h in a 2:1 ratio. The patients were followed for clinical responses and side effects.Results: The cure rate for cefmetazole was 89% and for cefoxitin it was 79% (P = 0.006). The adverse events were similar in both groups.Conclusions: Cefmetazole was significantly more effective than cefoxitin in the treatment of endometritis following cesarean delivery.


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