Results of medico-surgical approach to the treatment of pancreatic cancer in emergency

Catedra de Chirurgie nr. 1 “Nicolae Anestiadi”, Universitatea de Stat de Medicină şi Farmacie “Nicolae Testemiţanu”, IMSP Institutul de Medicină Urgentă, Chişinău, Republica Moldova, Al XIII-lea Congres al Asociației Chirurgilor „Nicolae Anestiadi” și al III-lea Congres al Societății de Endoscopie, Chirurgie miniminvazivă și Ultrasonografie ”V.M.Guțu” din Republica MoldovaIntroducere: Tumorile pancreatice (TP) reprezintă a cincea cea mai comună cauză de deces. Diagnosticul precoce rămâne o provocare, aceasta determinând rate considerabile de morbiditate şi mortalitate. Material şi metode: Studiu retrospectiv, 2014-2018, 147 pacienţi cu TP, B:F/1:1, vârsta medie 63,82±11,45ani. Adresarea a fost determinată de icter în 101(68,71%) cazuri, formaţiune intraabdominală − 29(19,73%), abdomen acut – 17(11,56%). Diagnosticul s-a stabilit: la 111(75,51%) − prin TC; la 9(6,12%) – prin RMN şi la 75(51,02%) – la CPGRE. În 128(87,07%) cazuri TP era localizată cefalic, în 19(12,95%) − corporeo-caudal. Pacienţii s-au repartizat în trei loturi: lot.I – stentare biliară la CPGRE sau transparietohepatică(58), lot.II – derivație bilio-digestivă(26), lot.III – rezecţie pancreatoduodenală(23) și pancreatectomie distală cu splenectomie(9). În 21,09% cazuri(n=31) s-a refuzat orice procedura terapeutică. Rezultate: Lotul I − 58(50,0%) cazuri, vârsta m=66,88±12,14ani, bilirubinemia m=250,47±146,33mmol/l, durata spitalizării m=9,81±4,8zile, mortalitatea p/op − 2(3,45%). Lotul II – 26(17,69%) cazuri, vârsta m=59,85±11,27ani, bilirubinemia m=112,0mmol/l, durata spitalizării m=22,58±10,32zile, mortalitatea p/op – 2(7,69%). Lotul III – 32(21,77%) pacienți, vârsta m=59,15±9,0ani, bilirubinemia m=87,0mmol/l în TP cefalice, în 8(34,78%) cazuri fiind stentați preoperator (bilirubinemia m=218,5±85,74mmol/l), durata spitalizării m=23,5zile, mortalitatea p/op − 6(18,75%), după duodenopancreatectomie(5), după pancreatectomie distală(1), din cauza complicațiilor septice(4), trombemboliei a.pulmonare(1), pancreonecrozei p/op(1). Concluzii: Examenul imagistic prin TC cu angiografie și/sau RMN este de prima intenție în diagnosticul și stabilirea tacticii chirurgicale în TP. Rata operațiilor rezecționale cu viză de radicalitate rămâne a fi sub limita mondială raportată, consecința diagnosticului tardiv și simptomatologiei nespecifice. Stentarea căilor biliare rămâne cea mai frecventă și, de cele mai multe ori, unica și ultima soluție în rezolvarea icterului mecanic compresiv.Background: Pancreatic tumors (PTs) are the fifth most common cause of death. Early diagnosis remains a challenge; consequently, morbidity and mortality rates are considerable. Methods and materials: Retrospective study, 2014-2018, 147 patients with PT, M:F ratio 1:1, age m=63.82±11.45years. At hospitalization jaundice was determined in 101(68.71%)cases, intra-abdominal tumor – 29(19.73%), acute abdomen − 17 (11.56%). The diagnosis of PT was established: CT in 111(75.51%); NMR − 9(6.12%), ERCP − 75 (51.02%). PTs were located in the head of the pancreas in 128(87.07%) cases, body or tail − 19(12.95%). The patients were divided into three groups: group.I – endoscopic biliary stenting or trans-parieto-hepatic drainage, group.II − biliodigestive derivation(26), group.III - pancreatoduodenal resection(23) and distal pancreatectomy with splenectomy(9). In 21.09%(n=31) cases patients refused any treatment. Results: Group.I − 58(50.0%), age m=66.88±12.14years, serum bilirubin level m=250.47±146,33mmol/l, hospitalization time m=9.81±4.8days, postoperative mortality − 2(3.45 %). Group.II − 26(17.69%), age m=59.85±11.27years, serum bilirubin level m=112.0mmol/l, hospitalization time m=22.58±10.32days, postoperative mortality − 2(7.69%). Group.III − 32(21.77%) patients, age m=59.15±9.0years, serum bilirubin level m=87.0mmol/l in patients with cephalic tumor, in 8(34.78%) cases biliary stent applied preoperatively (serum bilirubin level m=218,5±85,74mmol/l), hospitalization time m=23.5days, postoperative mortality − 6(18.75%), after duodenopancreatectomy(5), distal pancreatectomy(1), because of septic complications(4), pulmonary thromboembolism(1), postoperative pancreonecrosis(1). Conclusion: CT angiography and/or NMR are the first intention to diagnose and establish surgical tactics for PTs. The rate of radical resection remains to be under global level due to late diagnosis and nonspecific symptomatology, biliary stenting remains the most common and, frequently, the unique solution for jaundice in compressive mechanical jaundice

Efficacy and safety of two neutralising monoclonal antibody therapies, sotrovimab and BRII-196 plus BRII-198, for adults hospitalised with COVID-19 (TICO): a randomised controlled trial

We aimed to assess the efficacy and safety of two neutralising monoclonal antibody therapies (sotrovimab [Vir Biotechnology and GlaxoSmithKline] and BRII-196 plus BRII-198 [Brii Biosciences]) for adults admitted to hospital for COVID-19 (hereafter referred to as hospitalised) with COVID-19. In this multinational, double-blind, randomised, placebo-controlled, clinical trial (Therapeutics for Inpatients with COVID-19 [TICO]), adults (aged ≥18 years) hospitalised with COVID-19 at 43 hospitals in the USA, Denmark, Switzerland, and Poland were recruited. Patients were eligible if they had laboratory-confirmed SARS-CoV-2 infection and COVID-19 symptoms for up to 12 days. Using a web-based application, participants were randomly assigned (2:1:2:1), stratified by trial site pharmacy, to sotrovimab 500 mg, matching placebo for sotrovimab, BRII-196 1000 mg plus BRII-198 1000 mg, or matching placebo for BRII-196 plus BRII-198, in addition to standard of care. Each study product was administered as a single dose given intravenously over 60 min. The concurrent placebo groups were pooled for analyses. The primary outcome was time to sustained clinical recovery, defined as discharge from the hospital to home and remaining at home for 14 consecutive days, up to day 90 after randomisation. Interim futility analyses were based on two seven-category ordinal outcome scales on day 5 that measured pulmonary status and extrapulmonary complications of COVID-19. The safety outcome was a composite of death, serious adverse events, incident organ failure, and serious coinfection up to day 90 after randomisation. Efficacy and safety outcomes were assessed in the modified intention-to-treat population, defined as all patients randomly assigned to treatment who started the study infusion. This study is registered with ClinicalTrials.gov, NCT04501978. Between Dec 16, 2020, and March 1, 2021, 546 patients were enrolled and randomly assigned to sotrovimab (n=184), BRII-196 plus BRII-198 (n=183), or placebo (n=179), of whom 536 received part or all of their assigned study drug (sotrovimab n=182, BRII-196 plus BRII-198 n=176, or placebo n=178; median age of 60 years [IQR 50–72], 228 [43%] patients were female and 308 [57%] were male). At this point, enrolment was halted on the basis of the interim futility analysis. At day 5, neither the sotrovimab group nor the BRII-196 plus BRII-198 group had significantly higher odds of more favourable outcomes than the placebo group on either the pulmonary scale (adjusted odds ratio sotrovimab 1·07 [95% CI 0·74–1·56]; BRII-196 plus BRII-198 0·98 [95% CI 0·67–1·43]) or the pulmonary-plus complications scale (sotrovimab 1·08 [0·74–1·58]; BRII-196 plus BRII-198 1·00 [0·68–1·46]). By day 90, sustained clinical recovery was seen in 151 (85%) patients in the placebo group compared with 160 (88%) in the sotrovimab group (adjusted rate ratio 1·12 [95% CI 0·91–1·37]) and 155 (88%) in the BRII-196 plus BRII-198 group (1·08 [0·88–1·32]). The composite safety outcome up to day 90 was met by 48 (27%) patients in the placebo group, 42 (23%) in the sotrovimab group, and 45 (26%) in the BRII-196 plus BRII-198 group. 13 (7%) patients in the placebo group, 14 (8%) in the sotrovimab group, and 15 (9%) in the BRII-196 plus BRII-198 group died up to day 90. Neither sotrovimab nor BRII-196 plus BRII-198 showed efficacy for improving clinical outcomes among adults hospitalised with COVID-19. US National Institutes of Health and Operation Warp Spee