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A Multicenter Randomized Controlled Trial to Comparing Pancreatic Leaks With Enhanced Dissection vs. Enhanced Stapling After Distal Pancreatectomy
Christopher R. Shubert*1, Cristina R. Ferrone2, Carlos Fernandez-Del Castillo2, Dan S. Ubl1, Karla Ballman1, Michael J. Ferrara1, Michael L. Kendrick1, Michael B. Farnell1, Kmarie Reid Lombardo1, Michael G. Sarr1, David M. Nagorney1, Rory Smoot1, Mark J. Truty1, Florencia G. Que1
1Mayo Clinic, Rochester, MN; 2Massachusetts General Hospital, Boston, MA
Introduction:
Pancreatic leak is one of the most common complications following distal pancreatectomy. The primary objective of this trial is to compare the effectiveness of enhanced dissection closure of the pancreatic stump after distal pancreatectomy to that of enhanced stapling.
Study Design:
This study was a multicenter, prospective randomized trial of patients undergoing distal pancreatectomy randomized to either enhanced dissection or enhanced stapling closure of the pancreatic stump at Institutions A and B. A priori power analysis revealed to reach 80% power and to identify a 10% difference in leak rate between groups, 446 patients were needed for enrollment.
Results:
Enrollment was closed early due to poor accrual. Overall 67 patients were enrolled, 32 enhanced stapling and 35 enhanced dissection. Enrollment period extended from January 2010 to March 2014. There were no differences in preoperative patient demographics or risk factors (P>0.05).
Overall clinically significant leak rate was 17.9%; 12.5% for enhanced stapling and 22.9% for enhanced dissection(p=0.27). There were no differences in clinically significant or major complications; any pancreatic fistula related morbidity, postoperative length of stay, total length of stay, postop day 3 amylase, drainage occurring longer than 3 weeks, readmission, percutaneous drainage, duration of operation, estimated blood loss, grade of complication, pseudoaneurysm formation, ICU stay, or Grade C leak between the two treatment groups.
Post-hoc power analysis revealed, at the current difference in leak rates between the two treatment groups, it would require 422 patients to reach statistical significance.
Conclusion:
This is the first multi-centered randomized trial to evaluate the incidence of leak rate after distal pancreatectomy between two separate pancreatic transection methods. The trial closed early due to poor accrual. Given the accrual rate and the observed difference in leak rates it would have been impractical and neither financially nor technically feasible to continue the study. Even though there was a difference in leak rates between arms, statistical significance was not reached. Both treatment options will continue to represent the current standard of care and should be chosen based on surgeon comfort, experience and pancreas related factors.
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