Introduction: Pancreatic leak or fistula is the most frequent complication after left pancreatectomy. We performed a single-blinded, parallel-group, randomized controlled trial comparing stapled left pancreatectomy with stapled left pancreatectomy using mesh reinforcement of the staple line with either Seamguard or Peristrips Dry.
Methods: All patients undergoing left pancreatectomy at a large tertiary hospital were eligible for participation. Patients were randomized to either mesh reinforcement or no-mesh reinforcement intraoperatively after being determined a candidate for resection. Patients were blinded to the result of their randomization for 6 weeks. Primary outcome measure was clinically significant leak as defined by the ISGPF (International Study Group on Pancreatic Fistula) pancreatic leak grading system.
Results: One hundred patients were randomized to either mesh (54) or no-mesh (46) reinforcement of their pancreatic transection. There was 1 death in each group. ISGPF grade B and C leaks were seen in 1.9% (1/53) of patients undergoing resection with mesh reinforcement and 20% (11/45) of patients without mesh reinforcement (P = .0007).
Conclusions: Mesh reinforcement of pancreatic transection line significantly reduces the incidence of significant pancreatic fistula in patients undergoing left pancreatectomy.
Trial Registration: Clinicaltrials.gov: NCT01359410
This is a randomized-controlled trial evaluating the use of staple-line reinforcement to prevent pancreatic occlusion failure in distal (left) pancreatectomy. We found that clinically significant pancreatic occlusion failure was significantly decreased with the use of a mesh buttress of the stapled transection line.
*Departments of Surgery and
†Division of Biostatistics, Washington University School of Medicine
‡John Cochrane Veterans Administration Hospital, Saint Louis, MO.
Reprints: William G. Hawkins, MD, Department of Surgery, Washington University School of Medicine, 660 South Euclid, Box 8109, Saint Louis, MO 63110. E-mail: email@example.com.
Disclosure: This trial was funded by the Department of Surgery at Washington University School of Medicine. Statistical support was provided by the Biostatistics Core, Siteman Comprehensive Cancer Center, and NCI Cancer Center Support Grant P30 CA091842. Salary support was provided for 3 authors (N.A.H., M.R.P., F.M.J.) by the Washington University Surgical Oncology Training Grant (NIH-5T32CA00962122).