Randomized clinical trial and meta-analysis of the impact of a fibrin sealant patch on pancreatic fistula after distal pancreatectomy: CPR trial. Issue 3 (12th June 2021)

• Record Type: Journal Article
• Authors: Mungroop, T H; van der Heijde, N; Busch, O R; de Hingh, I H; Scheepers, J J; Dijkgraaf, M G; Groot Koerkamp, B; Besselink, M G; van Eijck, C H
• Is Part Of: BJS open. Volume 5:Issue 3(2021)
• Publication Date: 2021-06-12
• Subjects: Surgery -- Periodicals; 617.005
• DOI: 10.1093/bjsopen/zrab001
• Languages: English
• ISSNs: 2474-9842

Abstract

Abstract: Background: Postoperative pancreatic fistula (POPF) remains the main cause of morbidity in patients after distal pancreatectomy. The objective of this study was to investigate whether an absorbable fibrin sealant patch could prevent POPF after distal pancreatectomy. Methods: A multicentre, patient-blinded, parallel-group randomized superiority trial was performed in seven Dutch hospitals. Allocation was done using a computer-generated randomization list with a 1 : 1 allocation ratio and concealed varying permuted block sizes. Pancreatic stump closure with a fibrin patch was compared with standard treatment in patients undergoing distal pancreatectomy. The primary endpoint was the development of grade B/C POPF. A systematic review and meta-analysis was performed which combined the present findings with all available evidence. Results: Between October 2010 and August 2017, 247 patients were enrolled. Fifty-four patients (22.2 per cent) developed a POPF, 25 of 125 patients in the patch group versus 29 of 122 in the control group (20.0 versus 23.8 per cent; P = 0·539). No related adverse effects were observed. In the meta-analysis, no significant difference was seen between the patch and control groups (19.7 versus 22.0 per cent; odds ratio 0.89, 95 per cent c.i. 0.60 to 1.32; P = 0·556). Conclusion: Application of a fibrin patch to the pancreatic stump does not reduce the incidence of POPF in distal pancreatectomy. Future studies should focus on alternative fistula mitigation strategies, considering pancreatic neck thickness and duct size as risk factors. Trial registration number NL5876 (Netherlands Trial Registry). Abstract : Postoperative pancreatic fistula (POPF) remain a major concern in patients after distal pancreatectomy. Although stump closure with a fibrin sealant patch has shown promising results, in this multicenter, patient-blinded randomized controlled trial, patch application did not reduce the incidence of POPF.