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 Blockade of Interleukin Seventeen (IL–17A) with Secukinumab in Hospitalized COVID–19 patients – the BISHOP study.

2021 ◽  
Author(s):  
Gustavo Gomes Resende ◽  
Ricardo da Cruz Lage ◽  
Samara Quadros Lobe ◽  
Amanda Fonseca Medeiros ◽  
Alessandra Dias Costa e Silva ◽  
...  
Keyword(s):  
Adverse Events ◽  
Controlled Trial ◽  
Kidney Injury ◽  
Standard Of Care ◽  
Open Label ◽  
Upper Airways ◽  
Intention To Treat ◽  
Group A ◽  
Expert Input ◽  
Group B

Background: Patients with severe COVID-19 seem to have a compromised antiviral response and hyperinflammation. Neutrophils are critical players in COVID-19 pathogenesis. IL-17A plays a major role in protection against extracellular pathogens and neutrophil attraction and activation. We hypothesized that secukinumab, an anti-IL17A monoclonal antibody, could mitigate the deleterious hyperinflammation in COVID-19. Methods: BISHOP was an open-label, single-center, phase-II controlled trial. Fifty adults hospitalized Covid-19 patients, confirmed by a positive SARS-CoV-2 RT-PCR, were randomized 1:1 to receive 300mg of secukinumab subcutaneously at day-0 (group A) plus standard of care (SoC: antiviral drugs, antimicrobials, corticosteroids, and/or anticoagulants) or SoC alone (group B). A second dose of 300mg of secukinumab could be administered on day-7, according to staff judgment. The primary endpoint was ventilator-free days at day-28 (VFD-28). Secondary efficacy and safety outcomes were also explored. Findings: An intention-to-treat analysis showed no difference in VFD-28: 23.7 (95%CI 19.6-27.8) in group A vs. 23.8 (19.9-27.6) in group B, p=0.62; There was also no difference in hospitalization time, intensive care unit demand, the incidence of circulatory shock, acute kidney injury, fungal or bacterial co-infections, and severe adverse events. Pulmonary thromboembolism was less frequent in group A (4.2% vs. 26.2% p=0.04). There was one death in each group. Viral clearance, defined by the viral load fold change (2-ΔΔCT) in upper airways, between day-0 and day-7, was also similar: 0.17 (0.05-0.56) in group A vs. 0.24 (0.10-0.57) in group B. Interpretation: The efficacy of secukinumab in the treatment of Covid19 was not demonstrated. No difference between groups in adverse events and no unexpected events were observed. Funding: Novartis Brazil supported this research providing expert input in the development of the project, drug supply, data management, and monitoring.

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 Comparison of gabapentin and oxycodone-acetaminophen used for pre-emptive analgesia in patients undergoing double-port thoracoscopic pulmonary surgery: a randomized, double-blind, controlled trial.

2019 ◽  
Author(s):  
Li Li ◽  
XiJuan Li ◽  
JinMei Shen ◽  
LiJun Zhou
Keyword(s):  
Chronic Pain ◽  
Adverse Events ◽  
Controlled Trial ◽  
Opioid Consumption ◽  
Control Group ◽  
Double Blind ◽  
Pulmonary Surgery ◽  
Post Operative Pain ◽  
Group A ◽  
Group B

Abstract Background This study was designed to determine whether gabapentin is not inferior to the oxycodone-acetaminophen group used as pre-emptive analgesia in reducing post-operative pain. The post-operative pain of patients undergoing thoracoscopic pulmonary surgery, a routine operation procedure, is also a clinical problem that urgently needs to be further explored. We hypothesized that gabapentin is not inferior to oxycodone-acetaminophen.Methods Ninety patients were randomly divided into group A,n=30; group B,n=30; and group C,n=30. Patients in group A received oral gabapentin (300 mg) 2 h before surgery, similarly patients in group B received oral oxycodone-acetaminophen (330mg);Group C did not take any oral drugs; all patients were given self-controlled intravenous analgesia after surgery. NRS scores post-operative, opioid consumption 48 hours post-operative, analgesic-related adverse events, post-operative chronic pain after 2 months, were recorded.Results The NRS scores and opioid consumption 48 hours post-operative of intervention groups were significantly lower than the control group, and did not increase analgesic-related adverse events. The incidence of chronic pain 2 months post-operative in groups A and B was significantly lower than group C.Conclusion Oral gabapentin and oxycodone-acetaminophen alleviated the pain post-operative, reduced opioid consumption post-operative,promoted the recovery.

scholarly journals Performance Characteristics of a Lumen-Apposing Metal Stent for Pancreatic Fluid Collections: A Prospective Cohort Study

2020 ◽  
Author(s):  
Amit Dhillon ◽  
Suqing Li ◽  
Simrat Sandha ◽  
Pernilla D’Souza ◽  
Gurpal Sandha
Keyword(s):  
Cohort Study ◽  
Clinical Success ◽  
Performance Characteristics ◽  
Procedure Time ◽  
Technical Success ◽  
Ultrasound Guided ◽  
Pancreatic Fluid Collections ◽  
Pancreatic Fluid ◽  
Fluid Collections ◽  
Walled Off Necrosis

Abstract Background Endoscopic ultrasound-guided transmural drainage is the preferred management of pancreatic fluid collections (PFCs). Optimizing drainage is important and there remains debate as to the choice of stent. A recent trend towards the use of lumen-apposing metal stents (LAMS) has emerged. Aim To evaluate the performance characteristics of a LAMS based on a prospective protocol (CT scan 1 week after placement to assess for resolution and need for necrosectomy followed by stent removal within 3 weeks). Methods This is a descriptive prospective cohort study performed at a single centre. The primary outcome was clinical success. Secondary outcomes were technical success, procedure time, total number of endoscopic procedures with or without necrosectomy, stent indwell time, stent functionality and adverse events. Results Thirty-seven patients (21 males, mean age 46.5 years) underwent placement of LAMS for 41 PFCs (median size 12 cm). There were 18 pseudocysts and 23 walled-off necrosis. Clinical success was seen in 33 of 41 (80%) PFCs. Of the remaining eight patients, six underwent surgery and two patients died from underlying malignant disease (although their PFC had completely resolved). Technical success and stent functionality were 100%. The median procedure time was 14 min (interquartile range 11 min to 20 min). Of the 23 walled-off necrosis, 9 (39%) required necrosectomy. The median stent indwell time was 19 days (interquartile range 14 to 22 days). There were no serious adverse events. Conclusions Our protocol demonstrates excellent performance characteristics of LAMS. Their clinical efficacy and favourable safety profile suggest that they may be the preferred modality for endoscopic ultrasound-guided management of PFCs.

scholarly journals Endoscopic pancreatic necrosectomy: why scuff when you can flush the muck – make it an easy row to hoe

2017 ◽  
Vol 05 (09) ◽  
pp. E847-E853 ◽  
Author(s):  
Rinkesh Bansal ◽  
Rajesh Puri ◽  
Narendra Choudhary ◽  
Sumit Bhatia ◽  
Nisharg Patel ◽  
...  
Keyword(s):  
Hydrogen Peroxide ◽  
Adverse Events ◽  
Success Rate ◽  
Clinical Success ◽  
Tertiary Care ◽  
Clinical Success Rate ◽  
Technical Success ◽  
End Points ◽  
Technical Success Rate ◽  
Life Threatening

Abstract Background and aims Endoscopic ultrasound (EUS) guided drainage of symptomatic pancreatic walled-off necrosis (WON) followed by fully covered self-expanding metal stent (FCSEMS) placement offers several advantages such as higher technical success rate and the option of necrosectomy. The aim of this study was to evaluate the safety and efficacy of EUS guided drainage of patients with WON by using FCSEMS and intracavitary lavage with a solution containing hydrogen peroxide and adopting a step-up approach. Methods A prospective open label study was carried out at a single tertiary care center between January 2014 and January 2016. Patients with symptomatic WON who underwent EUS guided drainage followed by FCSEMS placement were included. Primary end points were complete drainage with improvement in symptoms or major adverse events. Secondary end points were minor adverse events related to the procedures. Results A total of 64 patients (mean age 36 years; 52 males) were included. Technical success was achieved in 100 % of patients and clinical success was achieved in 90.6 %. Complete drainage was achieved with FCSEMS alone in 18 (28.1 %), FCSEMS with necrosectomy using lavage in 40 (62.5 %), FCSEMS with percutaneous drainage (PCD) in 5 (7.8 %), and 1 (1.6 %) patient required salvage surgery. The major adverse event was life threatening bleeding in 3 (4.7 %) patients. Minor adverse events were non-life threatening bleeding in 2 (3.1 %) patients and stent migration in 3 (4.7 %) patients. Conclusion EUS guided WON drainage with FCSEMS followed by necrosectomy with lavage using a solution containing hydrogen peroxide as a step-up approach is a minimally invasive and effective method with a high technical and clinical success rate. Patients with solid debris > 40 % need aggressive management.

scholarly journals Endoscopic ultrasound-guided choledochoduodenostomy using partially-covered self-expandable metal stent in patients with malignant distal biliary obstruction and unsuccessful ERCP

2018 ◽  
Vol 06 (01) ◽  
pp. E67-E72 ◽  
Author(s):  
Praveer Rai ◽  
CR Lokesh ◽  
Amit Goel ◽  
Rakesh Aggarwal
Keyword(s):  
Adverse Events ◽  
Biliary Drainage ◽  
Biliary Obstruction ◽  
Patency Rate ◽  
Clinical Success ◽  
Metal Stent ◽  
Technical Success ◽  
Ultrasound Guided ◽  
Stent Patency ◽  
Post Procedure

Abstract Background and study aims Endoscopic ultrasound-guided choledochoduodenostomy (EUS-CDS) is an alternative to percutaneous transhepatic biliary drainage (PTBD) for patients with malignant distal biliary obstruction in whom ERCP has failed. We studied technical success, clinical success, stent patency rate and occurrence of adverse events in patients undergoing EUS-CDS with partially-covered self-expanding metal stent (PCSEMS). Patients and methods Medical records of consecutive patients with unresectable malignant distal biliary obstruction requiring biliary drainage who underwent EUS-CDS because of failure of attempt at ERCP were reviewed. EUS-CDS was done using 6-cm, PCSEMS (Wallflex, Boston Scientific). Technical success, clinical success (more than 50 % reduction in total bilirubin at 2 weeks post-procedure), stent patency rate and adverse events (AEs) were assessed. Patients were followed up for 3 months post-procedure. Results Between January 2015 and December 2016, 30 patients underwent EUS-CDS, including 20 (67 %) with failed biliary cannulation and 10 (33 %) with duodenal stenosis. Technical success was achieved in 28 patients, all of whom also had clinical success. Median total serum bilirubin decreased from 20 mg/dL to 5 mg/dL at 2 weeks post-procedure. Three patients (10 %) had adverse events (bile leak, hemobilia, stent block in one patient each; no stent migration); none of these adverse events was major and all were managed successfully. There were no procedure-related deaths. Five patients died of disease progression in the 3-month period post-procedure, and the 3-month dysfunction-free stent patency rate was 83 %. Conclusion EUS-CDS with a PCSEMS has a high technical and clinical success. Adverse events were infrequent, minor and could be managed easily.

scholarly journals Oral Tranexamic Acid for the Treatment of Melasma

2014 ◽  
Vol 10 (4) ◽  
pp. 40-43 ◽  
Author(s):  
D Karn ◽  
S KC ◽  
A Amatya ◽  
EA Razouria ◽  
M Timalsina
Keyword(s):  
Tranexamic Acid ◽  
Controlled Trial ◽  
Severity Index ◽  
Sustained Improvement ◽  
Treatment Measures ◽  
Group A ◽  
Group B ◽  
Novel Concept ◽  
High Treatment

Background Melasma poses a great challenge as its treatment is unsatisfactory and recurrence is high. Treatment of melasma using tranexamic acid (oral, topical or intralesional) is a novel concept. Objective To compare the efficacy of oral tranexamic acid with routine topical therapies for the treatment of melasma. Methods It is a prospective, interventional, randomized controlled trial conducted among 260 melasma patients. Patients were divided into two groups consisting of 130 patients each. First group (Group A) was given routine treatment measures and oral Tranexamic Acid while second group (Group B) was treated only with routine topical measures. Capsule Tranexamic Acid was prescribed at a dose of 250 mg twice a day for three months and cases were followed for three months. Response was evaluated on the basis of Melasma Assessment Severity Index (MASI). Mean scores between the two groups were then compared. Results Statistically significant decrease in the mean Melasma Assessment Severity Index from baseline to 8 and 12 weeks was observed among group A patients (11.08±2.91 vs 8.95±2.08 at week 8 and vs. 7.84±2.44 at week 12; p<0.05 for both). While among group B patients the decrease in mean score was significant at 8 weeks and insignificant at 12 weeks follow up (11.60±3.40 vs 9.9±2.61 at 8 weeks and vs. 9.26±3 at 12 weeks; p<0.05 for former but p>0.05 for later). Conclusion Addition of oral tranexamic acid provides rapid and sustained improvement in the treatment of melasma. DOI: http://dx.doi.org/10.3126/kumj.v10i4.10993 Kathmandu Univ Med J 2012;10(4):40-43

Radiofrequency ablation for markedly incompetent perforators versus compression therapy in the management of post-phelebtic venous ulcers: A randomized controlled trial

Vascular ◽  
2021 ◽  
pp. 170853812110100
Author(s):  
Mohamed Shukri Abdelgawad ◽  
Amr M El-Shafei ◽  
Hesham A Sharaf El-Din ◽  
Ehab M Saad ◽  
Tamer A Khafagy ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Radiofrequency Ablation ◽  
Controlled Trial ◽  
Compression Therapy ◽  
Randomized Controlled ◽  
Venous Ulcers ◽  
Group A ◽  
Group B ◽  
To Receive

Background Venus ulcers developed mainly due to reflux of incompetent venous valves in perforating veins. Patients and methods In this randomized controlled trial, 119 patients recruited over two years, with post-phelebtic venous leg ulcers, were randomly assigned into one of two groups: either to receive radiofrequency ablation of markedly incompetent perforators (Group A, n = 62 patients) or to receive conventional compression therapy (Group B, n = 57 patients). Follow-up duration required for ulcer healing continued for 24 months post randomization. Results Statistically significant shorter time to healing (ulcer complete healing or satisfactory clinical improvement) between both groups (56 patients, 90.3% of cases in Group A versus 44 patients 77.2% of cases in Group B) over the follow-up period of 24 months was attained ( p  = 0.001). Also, significantly different ulcer recurrence was recorded between both groups, 8 patients (12.9%) in Group A versus 19 patients (33.3%) in Group B ( p = 0.004). Conclusion In absence of deep venous obstruction, the monopolar radiofrequency ablation for incompetent perforators is a feasible and effective method that surpasses the traditional compression protocol for incompetent perforator-induced venous ulcers in terms of time required for healing even in the presence of unresolved deep venous valvular reflux.

scholarly journals Effects of different thermal insulation methods on the nasopharyngeal temperature in patients undergoing laparoscopic hysterectomy: a prospective randomized controlled trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Guanyu Yang ◽  
Zefei Zhu ◽  
Hongyu Zheng ◽  
Shifeng He ◽  
Wanyue Zhang ◽  
...  
Keyword(s):  
Thermal Insulation ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Laparoscopic Hysterectomy ◽  
Control Group ◽  
Prospective Randomized Controlled Trial ◽  
Warming Blanket ◽  
Group A ◽  
Insulation Effect ◽  
Group B

Abstract Background This study explored the comparison of the thermal insulation effect of incubator to infusion thermometer in laparoscopic hysterectomy. Methods We assigned 75 patients enrolled in the study randomly to three groups: Group A: Used warming blanket; group B: Used warming blanket and infusion thermometer; group C: Used warming blanket and incubator. The nasopharyngeal temperature at different time points during the operation served as the primary outcome. Results The nasopharyngeal temperature of the infusion heating group was significantly higher than that of the incubator group 60 min from the beginning of surgery (T3): 36.10 ± 0.20 vs 35.81 ± 0.20 (P<0.001)90 min from the beginning of surgery (T4): 36.35 ± 0.20 vs 35.85 ± 0.17 (P<0.001). Besides, the nasopharyngeal temperature of the incubator group was significantly higher compared to that of the control group 60 min from the beginning of surgery (T3): 35.81 ± 0.20 vs 35.62 ± 0.18 (P<0.001); 90 min from the beginning of surgery (T4): 35.85 ± 0.17 vs 35.60 ± 0.17 (P<0.001). Regarding the wake-up time, that of the control group was significantly higher compared to the infusion heating group: 24 ± 4 vs 21 ± 4 (P = 0.004) and the incubator group: 24 ± 4 vs 22 ± 4 (P = 0.035). Conclusion Warming blanket (38 °C) combined infusion thermometer (37 °C) provides better perioperative thermal insulation. Hospitals without an infusion thermometer can opt for an incubator as a substitute. Trial registration This trial was registered with ChiCTR2000039162, 20 October 2020.

scholarly journals Effectiveness and safety of secukinumab in 608 patients with psoriatic arthritis in real life: a 24-month prospective, multicentre study

RMD Open ◽  
2021 ◽  
Vol 7 (1) ◽  
pp. e001519
Author(s):  
Roberta Ramonda ◽  
Mariagrazia Lorenzin ◽  
Antonio Carriero ◽  
Maria Sole Chimenti ◽  
Raffaele Scarpa ◽  
...  
Keyword(s):  
Psoriatic Arthritis ◽  
Adverse Events ◽  
Disease Activity ◽  
Biological Treatment ◽  
Retention Rate ◽  
Real Life ◽  
Drug Retention ◽  
Group A ◽  
Group B ◽  
Drug Retention Rate

ObjectivesTo evaluate in a multicentric Italian cohort of patients with psoriatic arthritis (PsA) on secukinumab followed for 24 months: (1) the long-term effectiveness and safety of secukinumab, (2) the drug retention rate and minimal disease activity (MDA), (3) differences in the outcomes according to the biological treatment line: biologic-naïve patients (group A) versus multifailure (group B) patients.MethodsConsecutive patients with PsA receiving secukinumab were evaluated prospectively. Disease characteristics, previous/ongoing treatments, comorbidities and follow-up duration were collected. Disease activity/functional/clinimetric scores and biochemical values were recorded at baseline (T0), 6(T6), 12(T12) and 24(T24) months. Effectiveness was evaluated overtime with descriptive statistics; multivariate Cox and logistic regression models were used to evaluate predictors of drug-discontinuation and MDA at T6. Infections and adverse events were recorded.Results608 patients (41.28% men; mean (SD) age 52.78 (11.33)) were enrolled; secukinumab was prescribed as first-line biological treatment in 227 (37.34%) patients, as second (or more)-line biological treatment in 381 (62.66%). Effectiveness of secukinumab was shown with an improvement in several outcomes, such as Ankylosing Spondylitis Disease Activity Score (T0=3.26 (0.88) vs T24=1.60 (0.69) ;p=0.02) and Disease Activity Index for Psoriatic Arthritis (T0=25.29 (11.14) vs T24=7.69 (4.51); p<0.01). At T24, group A showed lower Psoriasis Area Severity Index (p=0.04), erythrocyte sedimentation rate and C reactive protein (p=0.03 ;p=0.05) and joint count (p=0.03) compared with group B. At T24, MDA was achieved in 75.71% of group A and 70.37% of group B. Treatment was discontinued in 123 (20.23%) patients, mainly due to primary/secondary loss of effectiveness, and in 22 due to adverse events. Retention rate at T24 was 71% in the whole population, with some difference depending on secukinumab dosage (p=0.004) and gender (p=0.05).ConclusionsIn a real-life clinical setting, secukimumab proved safe and effective in all PsA domains, with notable drug retention rate.

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