Clinical outcomes and costs of the use of fibrin sealant in pancreaticojejunal anastomosis after pancreaticoduodenectomy: a retrospective analysis study.
Ontology highlight
ABSTRACT: Objectives
The benefits of using a fibrin sealant to reinforce the pancreaticojejunal anastomosis are still contentious, a fact that justifies the study of its effects on clinical outcomes and costs of pancreaticoduodenectomy.Methods
Study of 62 consecutive patients submitted to pancreaticoduodenectomy, divided into two groups of 31 patients each: GWS = group with sealant and GWOS = group without sealant that were compared according to demographic, clinical, laboratory aspects, the incidence of postoperative pancreatic fistula (POPF), according to the definition of the International Study Group on Pancreatic Fistula, updated in 2016, and its postoperative complications categorized according to the Clavien classification, as well as hospital costs evaluated by the absorption costing method (with the exception of those related to medications).Results
The groups were homogeneous and there were no significant differences in the postoperative clinical course or in the indicators of hospital care between them. Hard texture of pancreatic tissue was the only protective factor against the development of POPF (RR = 0.29 (95%CI:0,12-0,68); p = 0.005). Moreover, hospital costs were higher in GWS than in GWOS (p < 0.0001).Conclusions
The use of fibrin sealant to reinforce pancreaticojejunal anastomosis did not improve the clinical and healthcare outcomes and, in addition, increased hospital costs.
SUBMITTER: Gaspar AF
PROVIDER: S-EPMC8267440 | biostudies-literature |
REPOSITORIES: biostudies-literature
Similar Datasets
Project description:BackgroundEsophagectomy is a pivotal curative modality for localized esophageal or esophagogastric junction cancer (EC or EJC). Postoperative anastomotic leakage (AL) remains problematic. The use of fibrin sealant (FS) may improve the strength of esophageal anastomosis and reduce the incidence of AL.AimTo assess the efficacy and safety of applying FS to prevent AL in patients with EC or EJC.MethodsIn this single-arm, phase II trial (Clinicaltrial.gov identifier: NCT03529266), we recruited patients aged 18-80 years with resectable EC or EJC clinically staged as T1-4aN0-3M0. An open or minimally invasive McKeown esophagectomy was performed with a circular stapled anastomosis. After performing the anastomosis, 2.5 mL of porcine FS was applied circumferentially. The primary endpoint was the proportion of patients with AL within 3 mo.ResultsFrom June 4, 2018, to December 29, 2018, 57 patients were enrolled. At the data cutoff date (June 30, 2019), three (5.3%) of the 57 patients had developed AL, including two (3.5%) with esophagogastric AL and one (1.8%) with gastric fistula. The incidence of anastomotic stricture and other major postoperative complications was 1.8% and 17.5%, respectively. The median time needed to resume oral feeding after operation was 8 d (Interquartile range: 7.0-9.0 d). No adverse events related to FS were recorded. No deaths occurred within 90 d after surgery.ConclusionPerioperative sealing with porcine FS appears safe and may prevent AL after esophagectomy in patients with resectable EC or EJC. Further phase III studies are warranted.
| S-EPMC7340992 | biostudies-literature
Project description:ObjectivesThe postoperative pancreatic fistula (POPF) is a major complication after pancreatic head resection whereby the technique of the anastomosis is a very influencing factor. The literature describes a possible protective role of the Blumgart anastomosis.MethodsPatients after pancreatic head resection with reconstruction through the modified Blumgart anastomosis (a 2 row pancreatic anastomosis through mattress sutures of the parenchyma and duct to mucosa pancreaticojejunostomy, Blumgart-group) were compared with patients after pancreatic head resection and reconstruction through the conventional pancreatojejunostomy (single suture technique of capsule and parenchyma to seromuscularis, PJ-group). The Data were collected retrospectively. Depending on the propensity score matching in a ratio of 1:2 comparison groups were set up. Blumgart-group (n=29) and PJ-group (n=56). The primary end point was the rate of POPF. Secondary goals were duration of operation, length of hospital stay, length of stay on intermediate care units and hospital mortality.ResultsThe rate of POPF (biochemical leak, POPF "grade B" and POPF "grade C") was less in the Blumgart-group, but without statistical relevance (p=0.23). Significantly less was the rate of POPF "grade C" in the Blumgart-group (p=0.03). Regarding the duration of hospital stay, length of stay on intermediate care units and hospital mortality, there was no relevant statistical difference between the groups (p=0.1; p=0.4; p=0.7). The duration of the operation was significantly less in the Blumgart-group (p=0.001).ConclusionsThe modified Blumgart anastomosis technique may have the potential to decrease major postoperative pancreatic fistula.
| S-EPMC7790181 | biostudies-literature
Project description:BackgroundThe mortality following pancreaticoduodenectomy has markedly decreased but remains an important challenge for the complexity of operation and technical skills involved. The present study aimed to clarify the impact of individualized pancreaticoenteric anastomosis and management to postoperative pancreatic fistula.MethodsData from 529 consecutive pancreaticoduodenectomies were retrospectively analysed from the Hepatobiliary and Pancreatic Surgery Unit I, Peking Cancer Hospital. The pancreaticoenteric anastomosis was determined based on the pancreatic texture and diameter of the main pancreatic duct. The amylase value of the drainage fluid was dynamically monitored postoperatively on days 3, 5 and 7. A low speed intermittent irrigation was performed in selected patients. Intraoperative and postoperative results were collected and compared between the pancreaticogastrostomy (PG) group and pancreaticojejunostomy (PJ) group.ResultsFrom 2010 to 2019, 529 consecutive patients underwent pancreaticoduodenectomy. Pancreaticogastrostomy was performed in 364 patients; pancreaticojejunostomy was performed in 150 patients respectively. The clinically relevant pancreatic fistula (CR-POPF) was 9.8% and mortality was zero. The soft pancreas, diameter of main pancreatic duct≤3 mm, BMI ≥ 25, operation time > 330 min and pancreaticogastrostomy was correlated with postoperative pancreatic fistula significantly. The CR-POPF of PJ was significantly higher than that of PG in soft pancreas patients; the operation time of PJ was shorter than that of PG significantly in hard pancreas patients. Intraoperative blood loss and operation time of PG was less than that of PJ significantly in normal pancreatic duct patients (p < 0.05).ConclusionsIndividualized pancreaticoenteric anastomosis should be determined based on the pancreatic texture and pancreatic duct diameter. The appropriate anastomosis and postoperative management could prevent mortality.
| S-EPMC7310108 | biostudies-literature
Project description:BackgroundThe superiority of Blumgart anastomosis (BA) over non-BA duct to mucosa (non-BA DtoM) still remains under debate.MethodsWe performed a systematic search of studies comparing BA to non-BA DtoM. The primary endpoint was CR-POPF. Postoperative morbidity and mortality, post-pancreatectomy hemorrhage (PPH), delayed gastric emptying (DGE), reoperation rate, and length of stay (LOS) were evaluated as secondary endpoints. The meta-analysis was carried out using random effect. The results were reported as odds ratio (OR), risk difference (RD), weighted mean difference (WMD), and number needed to treat (NNT).ResultsTwelve papers involving 2368 patients: 1075 BA and 1193 non-BA DtoM were included. Regarding the primary endpoint, BA was superior to non-BA DtoM (RD = 0.10; 95% CI: -0.16 to -0.04; NNT = 9). The multivariate ORs' meta-analysis confirmed BA's protective role (OR 0.26; 95% CI: 0.09 to 0.79). BA was superior to DtoM regarding overall morbidity (RD = -0.10; 95% CI: -0.18 to -0.02; NNT = 25), PPH (RD = -0.03; 95% CI -0.06 to -0.01; NNT = 33), and LOS (- 4.2 days; -7.1 to -1.2 95% CI).ConclusionBA seems to be superior to non-BA DtoM in avoiding CR-POPF.
| S-EPMC8093149 | biostudies-literature
Project description:BackgroundHeterologous fibrin sealant (HFS) consists of a fibrinogen-rich cryoprecipitate extracted from Bubalus bubalis buffalo blood and a thrombin-like enzyme purified from Crotalus durissus terrificus snake venom. This study evaluated the safety and immunogenicity of HFS, estimated the best dose, and assessed its preliminary efficacy in the treatment of chronic venous ulcers (CVU).MethodsA phase I/II non-randomized, single-arm clinical trial was performed on 31 participants, accounting for a total of 69 active CVUs. All ulcers were treated with HFS, essential fatty acid, and Unna boot for 12 weeks. The outcomes assessed were: (1) primary safety, immunogenicity analyses, and confirmation of the lowest safe dose; (2) secondary promising efficacy by analyzing the healing process. Immunogenicity was evaluated using the serum-neutralizing (IgM and IgG) and non-neutralizing (IgA and IgE) antibody techniques against the product. The immuno-detection of IgE class antibodies was assessed using dot-blot assay before and at the end of treatment. Positive samples on dot-blot assays were subsequently analyzed by western blotting to verify the results.ResultsNo severe systemic adverse events related to the use of HFS were observed. Local adverse events potentially related to treatment include ulcer pain (52%), peri-ulcer maceration (16%), peri-ulcer pruritus (12%), critical colonization (8%), peri-ulcer eczema (4%), the opening of new ulcers (4%), and increased ulcerated area 4%). Neutralizing and non-neutralizing antibodies did not show significant deviations at any of the evaluated time points. Blot assays showed that all patients presented negative immunological reactions, either before or after treatment, with the thrombin-like enzyme component. In addition, two participants showed a positive immunological reaction to the cryoprecipitate component, while another two were positive before and during treatment. Regarding the secondary outcomes of preliminary efficacy, a total healing and significant reduction of the area was observed in 47.5 and 22%, respectively. A qualitative improvement was observed in the wound beds of unhealed ulcers.ConclusionsThe investigational HFS bioproduct proved to be safe and non-immunogenic with a good preliminary efficacy for the treatment of CVU, according to the protocol and doses proposed. A multicentric phase III clinical trial will be necessary to verify these findings.
| S-EPMC7940668 | biostudies-literature
Project description:BackgroundRecent studies on perioperative fluid administration in patients undergoing major abdominal surgery have suggested that increased fluid loads are associated with worse perioperative outcomes. However, results of retrospective analyses of the relationship between intraoperative fluid (IOF) administration and perioperative outcomes in patients undergoing pancreaticoduodenectomy (PD) are conflicted. We sought to investigate this relationship in patients undergoing PD at our academic center.MethodsA retrospective analysis of 124 patients undergoing PD from 2007 to 2012 was performed. IOF administration rate (ml/kg/hr) was correlated with perioperative outcomes. Outcomes were also stratified by preoperative serum albumin level.ResultsRegression analyses were performed comparing independent perioperative variables, including IOF rate, to four outcomes variables: length of stay, severity of complications, number of complications per patient, and 30-day mortality. Both univariate and multivariate regression analyses showed IOF rate correlated with one or more perioperative outcomes. Patients with an albumin ≤ 3.0 g/dl who received more than the median IOF rate experienced more severe complications, while patients with an albumin >3.0 g/dl did not.ConclusionIncreased IOF administration is associated with worse perioperative outcomes in patients undergoing PD. Patients with low preoperative serum albumin levels (≤ 3.0 g/dl) may be a group particularly sensitive to volume overload.
| S-EPMC5481842 | biostudies-literature
Project description:In this preclinical protocol, an adjunct method is used in an attempt to overcome the limitations of conventional therapeutic approaches applied to bone repair of large bone defects filled with scaffolds. Thus, we evaluate the effects of photobiomodulation therapy (PBMT) on the bone repair process on defects filled with demineralized bovine bone (B) and fibrin sealant (T). The groups were BC (blood clot), BT (B + T), BCP (BC + PBMT), and BTP (B + T + PBMT). Microtomographically, BC and BCP presented a hypodense cavity with hyperdense regions adjacent to the border of the wound, with a slight increase at 42 days. BT and BTP presented discrete hyperdensing areas at the border and around the B particles. Quantitatively, BCP and BTP (16.96 ± 4.38; 17.37 ± 4.38) showed higher mean bone density volume in relation to BC and BT (14.42 ± 3.66; 13.44 ± 3.88). Histologically, BC and BCP presented deposition of immature bone at the periphery and at 42 days new bone tissue became lamellar with organized total collagen fibers. BT and BTP showed inflammatory infiltrate along the particles, but at 42 days, it was resolved, mainly in BTP. In the birefringence analysis, BT and BTP, the percentage of red birefringence increased (9.14% to 20.98% and 7.21% to 27.57%, respectively), but green birefringence was similar in relation to 14 days (3.3% to 3.5% and 3.5% to 4.2%, respectively). The number of osteocytes in the neoformed bone matrix proportionally reduced in all evaluated groups. Immunostaining of bone morphogenetic protein (BMP-2/4), osteocalcin (OCN), and vascular endothelial growth factor (VEGF) were higher in BCP and BTP when compared to the BC and BT groups (p < 0.05). An increased number of TRAP positive cells (tartrate resistant acid phosphatase) was observed in BT and BTP. We conclude that PBMT positively influenced the repair of bone defects filled with B and T.
| S-EPMC9572221 | biostudies-literature
Project description:Background Pancreaticoduodenectomy is a highly invasive procedure associated with high morbidity. Several preoperative variables are associated with postoperative complications. The role of perioperative factors is uncertain. The use of perioperative epidural analgesia is potentially associated with fewer postoperative surgical complications. We hypothesize that perioperative epidural analgesia might be associated with fewer surgical complications. Methods We reviewed data from 288 cases performed at our institution between 2012 and 2019, classifying patients into 2 groups: perioperative use of epidural analgesia and non-perioperative use of epidural analgesia. The decision to use epidural as an adjunct to general anesthesia was based on the judgment of the attending anesthesiologist. Uni- and multivariate analyses were then performed to determine factors associated with postoperative surgical complications, ie, postoperative pancreatic fistula, delayed gastric emptying, among others, after adjusting for confounders. Results Baseline and intraoperative factors were similar between the groups, except for sex and postoperative surgical complications. In the univariate analyses, factors associated with fewer postoperative surgical complications were the diameter of the pancreatic duct ≥ 6 mm, hard pancreatic gland parenchyma texture, younger age (< 65 years), and perioperative use of epidural analgesia. In the multivariate analyses, perioperative use of epidural analgesia was significantly associated with fewer postoperative surgical complications (odds ratio = 0.31; 95% confidence interval: 0.13–0.75; P = .009), even after adjusting for significant covariates. Conclusion Perioperative use of epidural analgesia might be associated with fewer postoperative surgical complications after pancreaticoduodenectomy even after adjusting for pancreatic gland parenchyma texture, pancreatic duct size, and age.
| S-EPMC9436794 | biostudies-literature
Project description:BackgroundThe aim of this systematic review was to assess the effectiveness of fibrin sealant compared to sutures in periodontal surgery.MethodsFive electronic databases (PubMed, Scopus, EBSCO, Cochrane and Web of Science) were screened from initiation to January 2021 for randomized controlled trials (RCTs) comparing fibrin sealant to sutures in periodontal surgery using this search equation: (Periodont* OR Periodontitis) AND ("fibrin tissue adhesive" OR "fibrin glue" OR "fibrin sealant" OR "fibrin sealant system" OR "fibrin adhesive system" OR "fibrin fibronectin sealant system"). Quality assessment of the included studies was performed using the revised tool to assess risk of bias in randomized trials (RoB 2). The level of evidence was evaluated using the GRADE tool.ResultsA total of 240 publications were found as search results in the screened databases. Four RCTs were included in this systematic review based on predetermined inclusion criteria. The trials were published between 1987 and 2014. All the RCTs compared fibrin sealant to sutures in periodontal surgery. The sample size included 101 patients. The overall risk of bias in this systematic review was at high risk in 75% of the studies, while 25% of the studies raised some concerns. The level of evidence evaluated using GRADE tool was very low.DiscussionThe current systematic review indicates a low level of evidence of the use of fibrin sealant as an alternative to sutures in periodontal practice. More interventional and multicentric studies should be conducted to support and confirm the results of the included studies.
| S-EPMC9052248 | biostudies-literature
Project description:Hematoma formation has persisted as the most common complication in rhytidectomy. The objective of this study is to determine the efficacy and safety of Artiss (Baxter) for use in rhytidectomies. In addition, we determine the use of fibrin tissue sealants by facial plastic surgeons. In this retrospective chart review, 120 patients in a single private practice were identified who underwent a rhytidectomy from August 2013 to January 2015 by a single facial plastic surgeon. The last 60 rhytidectomies performed with Tisseel (Baxter) were compared with the first 60 rhytidectomies performed with Artiss. All perioperative or postoperative complications were identified and recorded, focusing on the incidence of hematoma. In addition, a six-question survey was created and sent to all members of the American Academy of Facial Plastic and Reconstructive Surgery. Results of the survey were recorded and analyzed for trends or patterns in the data. In total, 120 patients were assessed. In the Tisseel group, two complications of fluid collection requiring needle aspiration were recorded. No other complications were found. In the Artiss group, 10 complications were recorded, including 9 fluid collections requiring needle aspiration and 1 hematoma. In total, 179 members of the American Academy of Facial Plastic and Reconstructive Surgery completed the six-question survey. Of all respondents, 61 (34%) use tissue sealants for rhytidectomies, whereas 118 (66%) do not. Artiss is efficacious and safe for use in rhytidectomies. Its use obviates the need for surgical drains, and complications are minimal and similar in rate to the use of Tisseel.
| S-EPMC5553512 | biostudies-other