Reinforced Staple Line on Leak Rate in Distal Pancreatectomy

Primary Outcome Measures:

• Clinically Significant Postoperative Pancreatic Leak at Any Time as Defined by the ISGPF Pancreatic Leak Grading System [ Time Frame: 100 days or removal of drain ]
  • Identified as being a grade B or grade C fistula or any fistula that altered the patients' management in any way
  • Determination of severity of pancreatic fistula was done using the ISGPF(International Study Group Pancreatic Fistula) leak/fistula/pancreatic occlusion failure
  • Grade B: >3x normal serum amylase, often well clinical condition, yes/no specific treatment, negative/positive ultrasound/CT, usually persistent drainage (>3 weeks), yes/no signs of infection, yes/no readmission, no sepsis, no reoperation, no death related to fistula
  • Grade C: >3x normal serum amylase, ill appearing/bad, requires specific treatment, positive ultrasound/CT, persistent drainage (>3 weeks), signs of infection, yes/no readmission, sepsis, reoperation, and death related to fistula
  
  

Secondary Outcome Measures:

• Occurrence of Any Fistula as Defined by the ISGPF Pancreatic Leak Grading System [ Time Frame: 100 days or removal of drain ]
  
• Time to Drain Removal [ Time Frame: 100 days or removal of drain ]
  
• Number of Non-pancreatic Adverse Events [ Time Frame: 100 days or removal of drain ]
  

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.