Postoperative pancreatic fistula: We need to redefine grades B and C

Hackert, Thilo; Hinz, Ulf; Pausch, Thomas; Fesenbeck, Irina; Strobel, Oliver; Schneider, Lutz; Fritz, Stefan; Büchler, Markus W.

doi:10.1016/j.surg.2015.09.014

Cited by 98 publications

(88 citation statements)

References 14 publications

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“…The outcome measures of the present trial were adapted retrospectively according to the new definition of POPF, but the incidence of biochemical leakage was kept in the report in order to provide a complete picture of the tightening capacity of fibrin sealant patches. The proportion of patients with biochemical leakage was significantly higher here than reported previously, whereas the incidence of grade B and C POPF was not. The authors are not able to provide a conclusive explanation for this as the participating centres have a high annual caseload of pancreatic resections, with pancreatojejunostomy performed according to general standards, with little variation.…”

Section: Discussioncontrasting

confidence: 87%

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

Schindl

Függer

Götzinger

et al. 2018

British Journal of Surgery

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BackgroundThe potential for a fibrin sealant patch to reduce the risk of postoperative pancreatic fistula (POPF) remains uncertain. The aim of this study was to evaluate whether a fibrin sealant patch is able to reduce POPF in patients undergoing pancreatoduodenectomy with pancreatojejunostomy.MethodsIn this multicentre trial, patients undergoing pancreatoduodenectomy were randomized to receive either a fibrin patch (patch group) or no patch (control group), and stratified by gland texture, pancreatic duct size and neoadjuvant treatment. The primary endpoint was POPF. Secondary endpoints included complications, drain‐related factors and duration of hospital stay. Risk factors for POPF were identified by logistic regression analysis.ResultsA total of 142 patients were enrolled. Forty‐five of 71 patients (63 per cent) in the patch group and 40 of 71 (56 per cent) in the control group developed biochemical leakage or POPF (P = 0·392). Fistulas were classified as grade B or C in 16 (23 per cent) and ten (14 per cent) patients respectively (P = 0·277). There were no differences in postoperative complications (54 patients in patch group and 50 in control group; P = 0·839), drain amylase concentration (P = 0·494), time until drain removal (mean(s.d.) 11·6(1·0) versus 13·3(1·3) days; P = 0·613), fistula closure (17·6(2·2) versus 16·5(2·1) days; P = 0·740) and duration of hospital stay (22·1(2·2) versus 18·2(0·9) days; P = 0·810) between the two groups. Multivariable logistic regression analysis confirmed that obesity (odds ratio (OR) 5·28, 95 per cent c.i. 1·20 to 23·18; P = 0·027), soft gland texture (OR 9·86, 3·41 to 28·54; P < 0·001) and a small duct (OR 5·50, 1·84 to 16·44; P = 0·002) were significant risk factors for POPF. A patch did not reduce the incidence of POPF in patients at higher risk.ConclusionThe use of a fibrin sealant patch did not reduce the occurrence of POPF and complications after pancreatoduodenectomy with pancreatojejunostomy. Registration number: 2013‐000639‐29 (EudraCT register).

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Section: Discussioncontrasting

confidence: 87%

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

Schindl

Függer

Götzinger

et al. 2018

British Journal of Surgery

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“…The extent of resection in the subgroup of patients with cancer had no additional impact on the risk of chyle leak, probably because lymphadenectomy was standardized in resections for cancer. The association of chyle leak with other complications, especially postoperative pancreatic fistula, is highly relevant, because these other complications occur frequently and have considerable impact on outcome. Some previous studies have already acknowledged the need to distinguish isolated chyle leak from that associated with other leaks.…”

Section: Discussionmentioning

confidence: 99%

Incidence, risk factors and clinical implications of chyle leak after pancreatic surgery

Strobel

Brangs

Hinz

et al. 2016

British Journal of Surgery

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“…14,15 More recent studies focussing on the impact of POPF, have questioned the clinical relevance of Grade A fistulas and they considered only Grade B and C fistulas as clinically relevant. 16 Some studies have even excluded Grade A fistulas in their reporting of POPF. Therefore, there is a discrepancy in the literature regarding the exact incidence of POPF.…”

Section: Discussionmentioning

confidence: 99%

Drain fluid amylase in defining clinically relevant postoperative pancreatic fistula following pancreaticoduodenectomy: day 5 is better than day 3

et al. 2017

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Background: Postoperative pancreatic fistula (POPF) remains the most serious complication of Pancreaticoduodenectomy. ISGPF defined POPF in 2005 based on drain fluid amylase on or after day 3 and graded the severity. But as Grade A fistulas are not clinically relevant, most of the clinicians do not consider them as POPF. Hence exact incidence of POPF is not known. Our aim is to see weather drain fluid amylase on or after day 5 can define clinically relevant POPF better than day 3.Methods: Prospective study included all patients who underwent Pancreaticoduodenectomy during the period January 2013 to November 2016. Serum and Drain fluid amylase were analyzed on Day 3. Those who met criteria of POPF underwent repeat amylase on Day 5. These patients were divided into 2 groups. Group A includes patients whose Day 5 amylase normalized and Group B where elevated Amylase persisted. Outcomes were compared in 2 Groups in terms of clinically relevant POPF (CRF), DGE, Haemorrhage (PPH), hospital stay and 30 Days mortality. Results were analysed and p value <0.05 was considered significant.Results: On 110 patients, 44 (40%) met ISGPF criteria of POPF. Of 44, 36 (82%) had normalized Amylase on Day 5 (Group A). Only 8 (18%) had persistent elevated amylase (Group B). None in Group A had CRF, whereas in Group B, 6(75%) had CRF and 2(25%) had only biochemical leak (p<0.0001). DGE was significantly higher in Group B (87.5% vs. 33.3%; p=0.013). PPH was seen in only 1 patient (Group A). Duration of hospital stay and 30day mortality were similar.Conclusions: Drain fluid amylase levels on or after Day 5 defines clinically relevant POPF better than levels on or after day 3.

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Postoperative pancreatic fistula: We need to redefine grades B and C

Cited by 98 publications

References 14 publications

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

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

Incidence, risk factors and clinical implications of chyle leak after pancreatic surgery

Drain fluid amylase in defining clinically relevant postoperative pancreatic fistula following pancreaticoduodenectomy: day 5 is better than day 3

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