Trial reportThe British journal of surgery2018
Randomized clinical trial of the effect of a fibrin sealant patch on pancreatic fistula formation after pancreatoduodenectomy.
Trial report in The British journal of surgery, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 30 papers, 7 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
30 citing papers in PubMed, 7 syntheses or guidelines pooled it, 44 citations in OpenAlex.
- Preventing pancreatic fistula following pancreatectomy: meta-analysis of randomized clinical trials.BJS open · 2026Pooled it
- Quality assurance of surgical interventions for pancreatic cancer: systematic review of multicentre randomized clinical trials.BJS open · 2025Pooled it
- Pooled it
- Fibrin sealants for the prevention of postoperative pancreatic fistula following pancreatic surgery.The Cochrane database of systematic reviews · 2023Pooled it
- Effect of polyglycolic acid mesh for prevention of pancreatic fistula after pancreatectomy: A systematic review and meta-analysis.Medicine · 2020Pooled it
- Efficacy of Pasireotide for Prevention of Postoperative Pancreatic Fistula in Pancreatic Surgery: a Systematic Review and Meta-analysis.Journal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tract · 2020Pooled it
- Fibrin sealants for the prevention of postoperative pancreatic fistula following pancreatic surgery.The Cochrane database of systematic reviews · 2020Pooled it
- Trial
- The Effect of Fibrinogen/Thrombin-Coated Collagen Patch (TachoSilWorld journal of surgery · 2019Trial
- Zero infection protocol in inflatable penile prosthesis surgery: a prospective cohort study using chlorhexidine-alcohol skin preparation and fibrin sealant hemostasis.International journal of impotence research · 2026Article
- Biomaterials in pancreatic surgery: progress and challenges in preoperative, intraoperative and postoperative care.Theranostics · 2026Review
- Regulating Enzyme Activity via Microaggregates Mediated by Phase Separation.Advanced science (Weinheim, Baden-Wurttemberg, Germany) · 2025Article
- Use of Histomorphological Features for the Prediction of Grade C Fistula after Whipple Procedure: A Difficult Task.Visceral medicine · 2025Article
- Health and Economic Advantages Associated With the Use of TachoSil: An Update of Systematic Review.Therapeutics and clinical risk management · 2025Article
- Article
- Stent A pancreaticojejunostomy after pancreatoduodenectomy: Is it always necessary?World journal of methodology · 2024Review
- Pancreatic Fistulas: Current Evidence and Strategy-A Narrative Review.Journal of clinical medicine · 2023Review
- Endoscopic Transmural Therapy of Pancreatic Fistulas in an Interdisciplinary Setting-A Retrospective Data Analysis.Journal of clinical medicine · 2023Article
- Surgical management of pancreatic ductal adenocarcinoma: a narrative review.Translational gastroenterology and hepatology · 2023Review
- Self-assembling peptide hydrogel SPG-178 as a pancreatic fistula-preventing agent.Langenbeck's archives of surgery · 2022Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
11 authors at 7 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
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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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.