Reinforced <i>versus</i> standard stapler transection on postoperative pancreatic fistula in distal pancreatectomy: multicentre randomized clinical trial

Abstract Background Postoperative pancreatic fistula is the leading cause of morbidity after distal pancreatectomy. Strategies investigated to reduce incidence have been disappointing. Recent data showed a reduction in postoperative with use synthetic mesh reinforcement staple line. Methods An RCT was conducted between May 2014 and February 2016 at four tertiary referral centres Sweden. Patients scheduled for pancreatectomy were eligible. Enrolled patients randomized during surgery stapler transection biological or standard transection. blinded allocation. The primary endpoint development any fistula. Secondary endpoints included morbidity, mortality, duration hospital stay. Results Some 107 106 an intention-to-treat analysis (56 reinforced stapling group, 50 group). No difference demonstrated terms clinically relevant fistulas (grade B C): 6 56 (11 per cent) versus 8 (16 (P = 0.332). There no groups overall complications: 45 (80 39 (78 respectively 0.765). Duration stay comparable: median (range 2–35) 9 (2–114) days 0.541). Conclusion Biodegradable line pancreas did not compared regular Registration number: NCT02149446 (http://www.clinicaltrials.gov).