Randomized clinical trial of the effect of a fibrin sealant patch on pancreatic fistula formation after pancreatoduodenectomy

Schindl, Martin; Függer, R.; Götzinger, P.; Längle, F.; Zitt, Matthias; Stättner, Stefan; Kornprat, Peter; Sahora, Klaus; Hlauschek, Dominik; Gnant, Michael

doi:10.1002/bjs.10840

Cited by 35 publications

(36 citation statements)

References 43 publications

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“…Major complications occurred in 40% of patients, which is comparable to results reported by other prospective series or randomized trials [ 18 – 20 ]. Rates of pancreatic fistula highly differ in the literature ranging from 2–63% [ 6 , 21 , 22 ]. In our cohort, 28.6% of patients experienced CR-POPF.…”

Section: Discussionmentioning

confidence: 99%

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Early Post‐Operative Pancreatitis and Systemic Inflammatory Response Assessed by Serum Lipase and IL‐6 Predict Pancreatic Fistula

et al. 2020

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Background Post-operative pancreatic fistula (POPF) remains a critical complication after pancreatic resection. This prospective pilot study evaluates perioperative markers of pancreatitis and systemic inflammation to predict clinically relevant grade B/C-POPF (CR-POPF). Methods All patients undergoing pancreatic resection from December 2017 to April 2019 were prospectively enrolled. Surgical procedures and outcomes were correlated with perioperative blood markers. ROC analysis was performed to assess their predictive value for CR-POPF. Cut-offs were calculated with the Youden index. Results In total, 70 patients were analysed (43 pancreatoduodenectomies and 27 distal pancreatectomies). In-hospital/90-d mortality and morbidity were 5.7/7.1% (n = 4/n = 5) and 75.7% (n = 53). Major complications (Clavien–Dindo ≥ 3a) occurred in 28 (40.0%) patients, CR-POPF in 20 (28.6%) patients. Serum lipase (cut-off > 51U/L) and IL-6 (> 56.5 ng/l) on POD3 were significant predictors for CR-POPF (AUC = 0.799, 95%-CI 0.686–0.912 and AUC = 0.784, 95%-CI 0.668–0.900; combined AUC = 0.858, 95%-CI 0.758–0.958; all p < 0.001). Patients with both or one factor(s) above cut-off more frequently developed CR-POPF than cases without (100 vs. 50% vs. 7.5%, p < 0.001). This also applied for overall and severe complications (p = 0.013 and p = 0.009). Conclusions Post-operative pancreatitis and inflammatory response are major determinants for development of POPF. A combination of serum lipase and IL-6 on POD3 is a highly significant early predictor of CR-POPF and overall complications, potentially guiding patient management. Clinical trial registration The study protocol was registered at clinicaltrials.gov (NCT04294797)

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Section: Discussionmentioning

confidence: 99%

“…In conclusion, post-operative complications and POPF remain a major issue even in high-volume centres [ 21 ]. The local pancreatic and systemic inflammatory response appears to be decisive, showing a strong association of POD3 serum IL-6 and lipase with CR-POPF and severe complications.…”

Section: Discussionmentioning

confidence: 99%

Early Post‐Operative Pancreatitis and Systemic Inflammatory Response Assessed by Serum Lipase and IL‐6 Predict Pancreatic Fistula

et al. 2020

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“…The in-hospital mortality rate in departments performing less than 10 pancreatic procedures per year was 12% compared to 8.1% in those with 20-29 procedures and 5.8% in hospitals with at least 30 procedures. Table 1 Rates of complications specific for pancreatic surgery, as described by [2,39] Specific complication PD (%) DP (%) Regarding publications on detailed postoperative mortality and morbidity after PR in Austria, multicentre data were recently reported in one prospective trial and two retrospective registries on pancreatic cancer and neuroendocrine tumour resections [8][9][10]. These publications all included only medium-to high-volume centres, with a resulting postoperative 30-to 90day mortality of 2.4 to 3.5%, showing that pancreatic surgery in specialized Austrian units is performed within internationally accepted safety range.…”

Section: Introductionmentioning

confidence: 99%

Outcomes following pancreatic resections—results and challenges of an Austrian university hospital compared to nationwide data and international centres

et al. 2019

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Background Despite clear advances in decreasing postoperative mortality below 4% after pancreatic resections in experienced centres, specific morbidity according to standardized definitions still remains high. While some recent multicentre studies have reported on complications after pancreatic surgery in Austria, detailed outcome data from single highvolume centres over longer time-periods are scarce. This study provides an in-depth picture of patient characteristics, indications, morbidity and mortality after pancreatic surgery in an Austrian tertiary referral centre. Methods All patients undergoing curative intent resection between 2010 and 2017 at the Medical University of Innsbruck were evaluated. Patient characteristics and procedural details, overall and specific complications including postoperative pancreatic fistula (POPF), delayed gastric emptying (DGE) and postpancreatectomy haemorrhage (PPH) rates according to accepted definitions are reported. Outcomes after pancreatic head resections, distal pancreatectomy and other types of resections are compared. Factors associated with severe and overall morbidity are evaluated by logistic regression modelling. Results A total of 343 patients underwent pancreatic resection, at a median of 64 years (53% males). Most

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“…Two retrospective studies reported that fibrin sealant patches are feasible and safe with 7.4%–20% POPF rates after PD with pancreaticojejunostomy [ 13 , 29 ]. Schindl et al [ 30 ] conducted a multicenter, randomized clinical trial to investigate the effect of using thrombin-coated collagen patches after PD. In the study, the rates of POPF were 63% in the intervention group and 56% in the control group, and clinically relevant POPF rates were 23% in the intervention group and 14% in the control group.…”

Section: Discussionmentioning

confidence: 99%

Effect of Flowable Thrombin-Containing Collagen-Based Hemostatic Matrix for Preventing Pancreatic Fistula after Pancreatectomy: A Randomized Clinical Trial

Park

Ko²,

Kang

et al. 2020

JCM

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Background: The aim of this study was to evaluate the safety and efficacy of a flowable hemostatic matrix, and their effects for postoperative pancreatic fistula (POPF) after pancreatectomy. Methods: This was a randomized, clinical, single-center, single-blind (participant), non-inferiority, phase IV, and parallel-group trial. The primary endpoint was the incidence of POPF. The secondary endpoints were risk factors for POPF, drain removal days, incidence of complication, 90-day mortality, and length of hospital stay. Results: This study evaluated a total of 53 patients, of whom 26 patients were in the intervention group (flowable hemostatic matrix) and 27 patients were in the control group (thrombin-coated collagen patch). POPF was more common in the control group than in the intervention group (59.3% vs. 30.8%, p = 0.037). Among participants who underwent distal pancreatectomy, POPF (33.3% vs. 92.3%, p = 0.004), and clinically relevant POPF (8.3% vs. 46.2%, p = 0.027) was more common in the control group. A multivariate logistic regression model identified flowable hemostatic matrix use as an independent negative risk factor for POPF, especially in cases of distal pancreatectomy (DP) (odds ratio 17.379, 95% confidential interval 1.453–207.870, p = 0.024). Conclusion: Flowable hemostatic matrix application is a simple, feasible, and effective method of preventing POPF after pancreatectomy, especially for patients with DP. Non-inferiority was demonstrated in the efficacy of preventing POPF in the intervention group compared to the control group.

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Randomized clinical trial of the effect of a fibrin sealant patch on pancreatic fistula formation after pancreatoduodenectomy

Cited by 35 publications

References 43 publications

Early Post‐Operative Pancreatitis and Systemic Inflammatory Response Assessed by Serum Lipase and IL‐6 Predict Pancreatic Fistula

Early Post‐Operative Pancreatitis and Systemic Inflammatory Response Assessed by Serum Lipase and IL‐6 Predict Pancreatic Fistula

Outcomes following pancreatic resections—results and challenges of an Austrian university hospital compared to nationwide data and international centres

Effect of Flowable Thrombin-Containing Collagen-Based Hemostatic Matrix for Preventing Pancreatic Fistula after Pancreatectomy: A Randomized Clinical Trial

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