A multicenter randomized controlled trial comparing pancreatic leaks after TissueLink versus SEAMGUARD after distal pancreatectomy (PLATS) NCT01051856

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• 作者：Christopher R. Shubert ; MD^a ; Christina R. Ferrone ; MD^b ; Carlos Fernandez-del Castillo ; MD^b ; Michael L. Kendrick ; MD^a ; Michael B. Farnell ; MD^a ; Rory L. Smoot ; MD^a ; Mark J. Truty ; MD^a ; Florencia G. Que ; MD^a ; ^{que.florencia@mayo.edu" class="auth_mail" title="E-mail the corresponding author}
• 关键词：Distal pancreatectomy ; TissueLink ; SEAMGUARD ; Postoperative pancreatic fistula
• 刊名：Journal of Surgical Research
• 出版年：2016
• 出版时间：November 2016
• 年：2016
• 卷：206
• 期：1
• 页码：32-40
• 全文大小：525 K

文摘

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.