The using of sealants in pancreatic surgery: A Systematic Review.
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ABSTRACT: Background
POPF derives from the pancreatic stump, which follows pancreatic resection and the pancreatoenteric anastomosis following pancreaticoduodenectomy. Since 1978 sealants have been used in pancreatic surgery to prevent pancreatic fistula after resection of the pancreatic head and tail or for the management of trauma and the treatment of low-output pancreatic fistula. Different types of fibrin sealants have been evaluated for their potential to reduce the occurrence of POPF.Methods
A systematic search of the electronic literature was performed using PubMed, Cochrane Library, and Scopus databases to obtain access to all publications, especially clinical trials, randomised controlled trials, and systematic reviews concerning fibrin sealants pancreatic surgery. Searching for "fibrin sealants pancreas," we found a total of 73 results on Pubmed, 61 on Scopus, and 14 on Cochrane Library (148 total results).Results
Eighteen studies were found on literature, following the criteria already described, concerning the use of fibrin sealants in pancreatic surgery. All articles described were published in the period between 1989 and 2019.Most of these were single centre studies. A total of 1032 patients were enrolled in this review. In the studies, sealants were used to reinforce pancreatic anastomoses and for the occlusion of the main pancreatic duct.Conclusion
CR-POPF is a fearful complication of pancreatic surgery; among the possible solutions to reduce the risk of onset, sealants were used on the pancreatic stump; today the sealants should be considered such as an option to reduce the CR-POPF, but the routine use in clinical practice has to be validated.
SUBMITTER: Serra F
PROVIDER: S-EPMC8053887 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:IntroductionPost-operative pancreatic fistula (POPF) is a common complication after partial pancreatic resection, and is associated with increased rates of sepsis, mortality and costs. The role of fibrin sealants in decreasing the risk of POPF remains debatable. The aim of this study was to evaluate the literature regarding the effectiveness of fibrin sealants in pancreatic surgery.MethodsA comprehensive database search was conducted. Only randomized controlled trials comparing fibrin sealants with standard care were included. A meta-analysis regarding POPF, intra-abdominal collections, post-operative haemorrhage, pancreatitis and wound infections was performed according to the recommendations of the Cochrane collaboration.ResultsSeven studies were included, accounting for 897 patients. Compared with controls, patients receiving fibrin sealants had a pooled odds ratio (OR) of developing a POPF of 0.83 [95% confidence interval (CI): 0.6-1.14], P = 0.245. There was a trend towards a reduction in post-operative haemorrhage (OR = 0.43 (95%CI: 0.18-1.0), P = 0.05) and intra-abdominal collections (OR = 0.52 (95%CI: 0.25-1.06), P = 0.073) in those patients receiving fibrin sealants. No difference was observed in terms of mortality, wound infections, re-interventions or hospital stay.ConclusionOn the basis of these results, fibrin sealants cannot be recommended for routine clinical use in the setting of pancreatic resection.
| S-EPMC3892308 | biostudies-literature
Project description:BackgroundEvidence comparing fibrin sealants (FSs) in surgery are limited. This study evaluated the efficacy and safety of FSs, and manual compression in peripheral vascular surgery.MethodsA systematic review of randomized trials was conducted in Medline, Embase, and Cochrane databases within the last 15 years. Data were available to conduct a network meta-analysis (NMA) in peripheral vascular surgery. Fibrin sealant treatment arms were further broken-down and assessed by clotting time (i.e., 2-min [2C] or 1-min [1C]). The primary efficacy outcome was the proportion of patients achieving hemostasis by 4 min (T4). Treatment-related serious and non-serious adverse events (AEs) were qualitatively assessed.ResultsFive studies (n = 693), were included in the NMA. Results predicted VISTASEAL 2C, followed by EVICEL 1C, had the highest probability of achieving T4. Compared with manual compression, significant improvements in T4 were found with VISTASEAL 2C (relative risk [RR] = 2.67, 95% CrI: 2.13-3.34), EVICEL 1C (RR = 2.58, 95% CrI: 2.04-3.23), VISTASEAL 1C (RR = 2.00, 95% CrI: 1.45-2.65), and TISSEEL 2C (RR = 1.99, 95% CrI: 1.48-2.60). TISSEEL 1C was not significantly different than manual compression (RR = 1.40, 95% CrI: 0.70-2.33). Among FSs, VISTASEAL 2C was associated with a significant improvements in T4 compared with VISTASEAL 1C (RR = 1.33, 95% CrI: 1.02-1.82), TISSEEL 2C (RR = 1.34, 95% CrI: 1.05-1.77), and TISSEEL 1C (RR = 1.90, 95% CrI: 1.18-3.74). Treatment-related serious and non-serious AE rates were typically lower than 2%.ConclusionsIn peripheral vascular surgeries, VISTASEAL 2C and EVICEL 1C were shown to have the highest probabilities for achieving rapid hemostasis among the treatments compared. Future studies should expand networks across surgery types as data become available.
| S-EPMC7782199 | biostudies-literature
Project description:BackgroundFibrin sealants are widely used in neurosurgery to seal the suture line, provide watertight closure, and prevent cerebrospinal fluid leaks. The aim of this systematic review is to summarize the current efficacy and safety literature of fibrin sealants in dura sealing and the prevention/treatment of cerebrospinal fluid leaks.MethodsA comprehensive electronic literature search was run in the following databases: Cochrane Database of Systematic Reviews, Cochrane Central Resister of Controlled Trials, clinicaltrials.gov, MEDLINE/PubMed, and EMBASE. Titles and abstracts of potential articles of interest were reviewed independently by 3 of the authors.ResultsA total of 1006 database records and additional records were identified. After screening for duplicates and relevance, a total of 78 articles were assessed by the investigators for eligibility. Thirty-eight were excluded and the full-text of 40 articles were included in the qualitative synthesis. Seven of these included only safety data and were included in the safety assessment. The remaining 33 articles included findings from 32 studies that enrolled a total of 2935 patients who were exposed to fibrin sealant. Among these 33 studies there were only 3 randomized controlled trials, with the remaining being prospective cohort analysis, case controlled studies, prospective or retrospective case series. One randomized controlled trial, with 89 patients exposed to fibrin sealant, found a greater rate of intraoperative watertight dura closure in the fibrin sealant group than the control group (92.1% versus 38.0%, p<0.001); however, post-operative cerebrospinal fluid leakage occurred in more fibrin sealant than control patients (6.7% versus 2.0%, p>0.05). Other clinical trials evaluated the effect of fibrin sealant in the postoperative prevention of cerebrospinal fluid leaks. These were generally lower level evidence studies (ie, not prospective, randomized, controlled trials) that were not designed or powered to demonstrate a significant advantage to fibrin sealant use. Two small case series studies evaluated the effect of fibrin sealants in persistent cerebrospinal fluid leak treatment, but did not establish firm efficacy conclusions. Specific adverse reports where fibrin sealants were used for dura sealing were limited, with only 8 cases reported in neurosurgical procedures since 1987 and most reporting only a speculative relationship/association with fibrin sealant exposure.ConclusionsA major finding of this systematic literature review is that there is a paucity of randomized studies that have evaluated the effectiveness and safety of fibrin sealants in providing intraoperative watertight dura closure and post-operative cerebrospinal fluid leakage. Among the limited studies available, evidence from a single randomized, controlled trial indicates that fibrin sealants provide a higher rate of intraoperative watertight closure of the dura suture line than control, albeit with a higher rate of postoperative cerebrospinal fluid leakage. Evidence from non-randomized, controlled trials suggests that fibrin sealants may be effective in preventing cerebrospinal fluid leaks with an acceptable safety profile. There is a substantial need for randomized, controlled clinical trials or well-designed prospective observational trials where the conduct of a randomized trial is not feasible to fully assess the impact of fibrin sealant utilization on the rates of intraoperative dura closure, postoperative cerebrospinal leakage, and safety.
| S-EPMC4847933 | biostudies-literature
Project description:IntroductionPancreatic resections for malignant or benign diseases are associated with major morbidity and changes in physiology. To reduce perioperative complications and enhance recovery, many types of perioperative medical management have been introduced. The aim of this study was to provide an evidence-based overview on the best perioperative drug treatment.MethodsThe electronic bibliographic databases Medline, Embase, CENTRAL, and Web of Science were systematically searched for randomized controlled trials (RCT) evaluating perioperative drug treatments in pancreatic surgery. The investigated drugs were somatostatin analogues, steroids, pancreatic enzyme replacement therapy (PERT), prokinetic therapy, antidiabetic drugs, and proton pump inhibitors (PPI). Targeted outcomes in each drug category were meta-analyzed.ResultsA total of 49 RCT were included. The analysis of somatostatin analogues showed a significantly lower incidence of postoperative pancreatic fistula (POPF) in the somatostatin group compared to the control group (OR 0.58, 95% CI: 0.45 to 0.74). The comparison of glucocorticoids versus placebo showed significantly less POPF in the glucocorticoid group (OR 0.22, 95% CI: 0.07 to 0.77). There was no significant difference in DGE when erythromycin was compared to placebo (OR 0.33, 95% CI: 0.08 to 1.30). The other investigated drug regimens could only be analyzed qualitatively.ConclusionThis systematic review provides a comprehensive overview on perioperative drug treatment in pancreatic surgery. Some often-prescribed perioperative drug treatments lack high quality evidence and further research is needed.
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Project description:BACKGROUND:Gastric decompression after pancreatic surgery has been a routine procedure for many years. However, this procedure has often been waived in non-pancreatic abdominal surgeries. The aim of this meta-analysis was to determine the necessity of routine gastric decompression (RGD) following pancreatic surgery. METHODS:PubMed, the Cochrane Library, EMBASE, and Web of Science were systematically searched to identify relevant studies comparing outcomes of RGD and no gastric decompression (NGD) after pancreatic surgery. The overall complications, major complications, mortality, delayed gastric emptying (DGE); clinically relevant DGE (CR-DGE), postoperative pancreatic fistula (POPF), clinically relevant POPF (CR-POPF), secondary gastric decompression, and the length of hospital stay were evaluated. RESULTS:A total of six comparative studies with a total of 940 patients were included. There were no differences between RGD and NGD groups in terms of the overall complications (OR?=?1.73, 95% CI: 0.60-5.00; p?=?0.31), major complications (OR?=?2.22, 95% CI: 1.00-4.91; p?=?0.05), incidence of secondary gastric decompression (OR?=?1.19, 95% CI: 0.60-2.02; p?=?0.61), incidence of overall DGE (OR?=?2.74; 95% CI: 0.88-8.56; p?=?0.08; I2 =?88%), incidence of CR-POPF (OR?=?1.28, 95% CI: 0.76-2.15; p?=?0.36), and incidence of POPF (OR?=?1.31, 95% CI: 0.81-2.14; p?=?0.27). However, RGD was associated with a higher incidence of CR-DGE (OR?=?5.45; 95% CI: 2.68-11.09; p?<?0.001, I2 =?35%), a higher rate of mortality (OR?=?1.53; 95% CI: 1.05-2.24; p?=?0.03; I2 =?83%), and a longer length of hospital stay (WMD?=?5.43, 95% CI: 0.30 to 10.56; p?=?0.04; I2 =?93%). CONCLUSIONS:Routine gastric decompression in patients after pancreatic surgery was not associated with a better recovery, and may be unnecessary after pancreatic surgery.
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Project description:The incorporation of remineralizing additives into sealants has been considered as a feasible way to prevent caries by potential remineralization through ions release. Thus, this systematic review aimed to identify the remineralizing additives in resin-based sealants (RBS) and assess their performance. Search strategies were built to search four databases (PubMed, MEDLINE, Web of Science and Scopus). The last search was conducted in June 2020. The screening, data extraction and quality assessment were completed by two independent reviewers. From the 8052 screened studies, 275 full-text articles were assessed for eligibility. A total of 39 laboratory studies matched the inclusion criteria. The methodologies used to assess the remineralizing effect included microhardness tests, micro-computed tomography, polarized-light microscopy, ions analysis and pH measurements. Calcium phosphate (CaP), fluoride (F), boron nitride nanotubes (BNN), calcium silicate (CS) and hydroxyapatite (HAP) were incorporated into resin-based sealants in order to improve their remineralizing abilities. Out of the 39 studies, 32 studies focused on F as a remineralizing agent. Most of the studies confirmed the effectiveness of F and CaP on enamel remineralization. On the other hand, BNN and CS showed a small or insignificant effect on remineralization. However, most of the included studies focused on the short-term effects of these additives, as the peak of the ions release and concentration of these additives was seen during the first 24 h. Due to the lack of a standardized in vitro study protocol, a meta-analysis was not conducted. In conclusion, studies have confirmed the effectiveness of the incorporation of remineralizing agents into RBSs. However, the careful interpretation of these results is recommended due to the variations in the studies' settings and assessments.
| S-EPMC8877949 | biostudies-literature
Project description:IntroductionPancreatic surgery is a large and complex field of research. Several evidence gaps exist for specific diseases or surgical procedures. An overview on existing knowledge is needed to plan and prioritise future research. The aim of this project is to create a systematic and living evidence map of pancreatic surgery.Methods and analysisA systematic literature search in MEDLINE (via PubMed), Web of Science and Cochrane Central Register of Controlled Trials will be performed searching for all randomised controlled trials (RCT) and systematic reviews (SR) on pancreatic surgery. RCT and SR will be grouped in research topics. Baseline and outcome data from RCT will be extracted, presented and effect sizes meta-analysed. Data from SR will be used to identify evidence gaps. A freely accessible web-based evidence map in the format of a mind map will be created. The evidence map and meta-analyses will be updated periodically.DisseminationAfter completion of the project, a permanently updated evidence map of pancreatic surgery will be available to patients, physicians, researchers and funding bodies via www.evidencemap.surgery. Its use will allow clinical decision-making based on primary data and prioritisation of future research endeavours.Prospero registration numberCRD42019133444.
| S-EPMC6773280 | biostudies-literature
Project description:ObjectiveTo summarize the available clinical evidence on the relative effectiveness of retention of resin-based pit and fissure sealants (PFS) with that of flowable composites on occlusal surfaces of permanent teeth when evaluated in clinical trials.SourcesElectronic searches were performed in PubMed and Cochrane Library for the identification of relevant studies, from their inception until February 2020 and an additional search was done with the reference lists of included articles.Study selectionThe review protocol followed the PRISMA guidelines and was registered in PROSPERO (CRD42018112805). The risk of bias of the studies was independently appraised using the revised Cochrane Risk of Bias tool (RoB 2.0).DataTen articles were considered relevant for qualitative synthesis. The data extracted from two of the included articles showed statistically significant difference between the two materials based on their retention potential, of which one article favored superior retention of flowable composites and one article favored higher retention of PFS and the other eight studies showed no significant difference between the two materials.ConclusionThe current review has shown evidence suggesting the effective retention of resin-based pit-and-fissure sealants and flowable composites when applied to prevent occlusal caries in permanent molars, however, this evidence is of low quality. Carefully designed long-term clinical trials are required to support the results of this review.Clinical significanceThis is an important topic that would be of significant interest in the field of preventive dentistry, where sealants are the primary recommended method to prevent caries. The clinical efficacy of sealants is directly linked to their potential to retain and this systematic review focuses on comparing the relative effectiveness of resin-based pit-and-fissure-sealants with flowable composites in permanent teeth.
| S-EPMC7519376 | biostudies-literature
Project description:BackgroundThe rate of patients with pancreatic ductal adenocarcinoma (PDAC) receiving neoadjuvant chemotherapy is increasing, but upfront resection is still offered to most patients with resectable or borderline resectable disease. Encouraging data reported in adjuvant chemotherapy trials prompts surgeons towards upfront surgery, but such trials are subject to a significant selection bias. This systematic review aims to summarize available high-quality evidence regarding survival of patients treated with upfront surgery for PDAC.MethodsPubmed, Cochrane, and Web of Science Databases were interrogated for prospective studies published between 2000 and 2021 that included at least a cohort of patients treated with upfront surgery for resectable or borderline resectable PDAC. The Cochrane Collaboration's risk-of-bias tool for randomized trials (RoB-2) was used to assess risk of bias in all randomized studies. Patient weighted median overall survival (OS) and disease-free survival (DFS) were calculated.ResultsOverall, 8,341 abstracts were screened, 17 reports were reviewed in full text, and finally 5 articles and 1 conference abstract underwent data extraction. Included studies were published between 2014 and 2021. All studies were RCTs comparing different neoadjuvant treatment strategies to upfront surgery. Three studies included only resectable PDAC patients, two studies recruited patients with resectable and borderline resectable disease, and one study selected only borderline resectable patients. A total of 439 patients were included in the upfront resection cohorts of the 6 studies, ranging between 20 to 180 patients per study. The weighted median OS after upfront surgery was 18.8 (95% CI 12.4 - 20.6) months. Median DFS was 9 (95% CI 1.6 - 12.5) months. Resection rate was 74.5% (range 65-90%). Adjuvant treatment was initiated in 68% (range 43-77%) of resected patients.ConclusionsHigh-quality data for PDAC patients undergoing upfront surgery is scarce. Meta-analysis from the included studies showed a significantly shorter OS and DFS compared to recently published studies focusing on adjuvant combination chemotherapy, suggesting that the latter may overestimate survival due to the exclusion of most patients scheduled for upfront surgery.
| S-EPMC8784375 | biostudies-literature
Project description:Current treatment recommendations for resectable pancreatic cancer support upfront resection and adjuvant therapy. Randomized controlled trials offering comparison with the emerging neoadjuvant approach are lacking. This review aims to compare both treatment strategies for resectable pancreatic cancer. PubMed, MEDLINE, Embase, Cochrane Database and Cochrane Databases were searched for studies comparing neoadjuvant and surgery-first with adjuvant therapy for resectable pancreatic cancer. A Bayesian network meta-analysis was conducted using the Markov chain Monte Carlo method. Cochrane Collaboration's risk of bias, ROBINS-I and GRADE tools were used to assess quality and risk of bias of included trials. 9 studies compared neoadjuvant therapy and surgery-first with adjuvant therapy (n = 22,285). Aggregate rate (AR) of R0 resection for neoadjuvant therapy was 0.8008 (0.3636-0.9144) versus 0.7515 (0.2026-0.8611) odds ratio (O.R.) 1.27 (95% CI 0.60-1.96). 1-year survival AR for neoadjuvant therapy was 0.7969 (0.6061-0.9500) versus 0.7481 (0.4848-0.8500) O.R. 1.38 (95% CI 0.69-2.96). 2-year survival AR for neoadjuvant therapy was 0.5178 (0.3000-0.5970) versus 0.5131 (0.2727-0.5346) O.R. 1.26 (95% CI 0.94-1.74). 5-year AR survival for neoadjuvant therapy was 0.2069 (0.0323-0.3300) versus 0.1783 (0.0606-0.2300) O.R. 1.19 (95% CI 0.65-1.73). In conclusion neoadjuvant therapy may offer benefit over surgery-first and adjuvant therapy. However, further randomized controlled trials are needed.
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