TY - JOUR
T1 - A multicenter randomized controlled trial comparing pancreatic leaks after TissueLink versus SEAMGUARD after distal pancreatectomy (PLATS) NCT01051856
AU - Shubert, Christopher R.
AU - Ferrone, Christina R.
AU - Fernandez-del Castillo, Carlos
AU - Kendrick, Michael L.
AU - Farnell, Michael B.
AU - Smoot, Rory L.
AU - Truty, Mark J.
AU - Que, Florencia G.
N1 - Publisher Copyright:
© 2016
PY - 2016/11/1
Y1 - 2016/11/1
N2 - Background Pancreatic leak is common after distal pancreatectomy. This trial sought to compare TissueLink closure of the pancreatic stump to that of SEAMGUARD. Methods A multicenter, prospective, trial of patients undergoing distal pancreatectomy randomized to either TissueLink or SEAMGUARD. Results Enrollment was closed early due to poor accrual. Overall, 67 patients were enrolled, 35 TissueLink and 32 SEAMGUARD. The two groups differed in American Society of Anesthesiologist class and diagnosis at baseline and were relatively balanced otherwise. Overall, 37 of 67 patients (55%) experienced a leak of any grade, 15 (46.9%) in the SEAMGUARD arm and 22 (62.9%) in the TissueLink arm (P = 0.19). The clinically significant leak rate was 17.9%; 22.9% for TissueLink and 12.5% for SEAMGUARD (P = 0.35). There were no statistically significant differences in major or any pancreatic fistula–related morbidity between the two groups. Conclusions This is the first multicentered randomized trial evaluating leak rate after distal pancreatectomy between two common transection methods. Although a difference in leak rates was observed, it was not statistically significant and therefore does not provide evidence of the superiority of one technique over the other. Choice should remain based on surgeon comfort, experience, and pancreas characteristics.
AB - Background Pancreatic leak is common after distal pancreatectomy. This trial sought to compare TissueLink closure of the pancreatic stump to that of SEAMGUARD. Methods A multicenter, prospective, trial of patients undergoing distal pancreatectomy randomized to either TissueLink or SEAMGUARD. Results Enrollment was closed early due to poor accrual. Overall, 67 patients were enrolled, 35 TissueLink and 32 SEAMGUARD. The two groups differed in American Society of Anesthesiologist class and diagnosis at baseline and were relatively balanced otherwise. Overall, 37 of 67 patients (55%) experienced a leak of any grade, 15 (46.9%) in the SEAMGUARD arm and 22 (62.9%) in the TissueLink arm (P = 0.19). The clinically significant leak rate was 17.9%; 22.9% for TissueLink and 12.5% for SEAMGUARD (P = 0.35). There were no statistically significant differences in major or any pancreatic fistula–related morbidity between the two groups. Conclusions This is the first multicentered randomized trial evaluating leak rate after distal pancreatectomy between two common transection methods. Although a difference in leak rates was observed, it was not statistically significant and therefore does not provide evidence of the superiority of one technique over the other. Choice should remain based on surgeon comfort, experience, and pancreas characteristics.
KW - Distal pancreatectomy
KW - Postoperative pancreatic fistula
KW - SEAMGUARD
KW - TissueLink
UR - http://www.scopus.com/inward/record.url?scp=84982851375&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84982851375&partnerID=8YFLogxK
U2 - 10.1016/j.jss.2016.06.034
DO - 10.1016/j.jss.2016.06.034
M3 - Article
C2 - 27916372
AN - SCOPUS:84982851375
SN - 0022-4804
VL - 206
SP - 32
EP - 40
JO - Journal of Surgical Research
JF - Journal of Surgical Research
IS - 1
ER -