Reinforced Staple Line on Leak Rate in Distal Pancreatectomy

The investigators propose a randomized, controlled trial of stapled pancreatic transection versus mesh reinforced stapled pancreatic transection. For the duration of the study period, participating surgeons will utilize a standardized staple technique. Either a reabsorbable polytrimethylene carbonate mesh (SEAMGUARD®) or reabsorbable strips of bovine pericardium (PERI-STRIPS DRY®) will be used to reinforce the stapled pancreatic transection line in the test group. In order to have a uniform test method, the investigators will utilize a laparoscopic stapling device for both open and laparoscopic procedures and a uniform staple size (4.8mm).

Pancreatic leak remains a significant cause of morbidity and extra cost following distal pancreatectomy. Historically, previous attempts to reduce the leak rate have met with limited success. To examine this problem the investigators propose a randomized, controlled trial of stapled pancreatic transection versus mesh reinforced stapled pancreatic transection. For the duration of the study period, participating surgeons will utilize a standardized staple technique. Either a reabsorbable polytrimethylene carbonate mesh (SEAMGUARD®) or reabsorbable strips of bovine pericardium (PERI-STRIPS DRY®) will be used to reinforce the stapled pancreatic transection line in the test group. In order to have a uniform test method, the investigators will utilize a laparoscopic stapling device for both open and laparoscopic procedures and a uniform staple size (4.8mm). A drain will be placed in the left upper quadrant at the time of resection. Drainage of the pancreatic resection bed is widely accepted and remains our current standard of care.

• Procedure: Mesh reinforced staple line
  Reinforce the pancreatic transaction with SEAMGUARD®
• Procedure: Stapled without mesh reinforcement
  Stapled without mesh reinforcement (PERI-STRIPS DRY®)

• Active Comparator: Mesh reinforced staple line
  Mesh reinforced staple line (SEAMGUARD®)
  Intervention: Procedure: Mesh reinforced staple line
• Active Comparator: Stapled without mesh reinforcement
  Stapled without mesh reinforcement (PERI-STRIPS DRY®)
  Intervention: Procedure: Stapled without mesh reinforcement

• Hawkins WG. To mesh or not to mesh, that is the question: comment on "Use of Seamguard to prevent pancreatic leak following distal pancreatectomy". Arch Surg. 2009 Oct;144(10):899. No abstract available.
• Johnston FM, Cavataio A, Strasberg SM, Hamilton NA, Simon PO Jr, Trinkaus K, Doyle MB, Mathews BD, Porembka MR, Linehan DC, Hawkins WG. The effect of mesh reinforcement of a stapled transection line on the rate of pancreatic occlusion failure after distal pancreatectomy: review of a single institution's experience. HPB (Oxford). 2009 Feb;11(1):25-31.
• Thaker RI, Matthews BD, Linehan DC, Strasberg SM, Eagon JC, Hawkins WG. Absorbable mesh reinforcement of a stapled pancreatic transection line reduces the leak rate with distal pancreatectomy. J Gastrointest Surg. 2007 Jan;11(1):59-65.
• Hamilton NA, Porembka MR, Johnston FM, Gao F, Strasberg SM, Linehan DC, Hawkins WG. Mesh reinforcement of pancreatic transection decreases incidence of pancreatic occlusion failure for left pancreatectomy: a single-blinded, randomized controlled trial. Ann Surg. 2012 Jun;255(6):1037-42.

Inclusion Criteria:

• Participants must be 18 years or older and able to give consent. Any patient undergoing a distal pancreatectomy, laparoscopic or open, will be eligible for randomization.
• No exclusion is provided for primary diagnosis. In the event of a patient undergoing a planned resection of another organ or organs with only a possibility of a distal pancreatic resection (i.e. colectomy, hepatectomy, gastrectomy, nephrectomy), the patient will still be eligible for inclusion in the study. We expect that some patients will be randomized but not resected (ie metastasis identified). A few patients may not be stapled using the study device for technical reasons (ie the stapler does not fit). The data will be analyzed in an intent-to-treatment approach.

Exclusion Criteria: None specified