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

Christopher R. Shubert, Christina R. Ferrone, Carlos Fernandez-del Castillo, Michael L. Kendrick, Michael B. Farnell, Rory Smoot, Mark Truty, Florencia Que

Research output: Contribution to journalArticle

7 Citations (Scopus)

Abstract

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.

Original languageEnglish (US)
Pages (from-to)32-40
Number of pages9
JournalJournal of Surgical Research
Volume206
Issue number1
DOIs
StatePublished - Nov 1 2016

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Pancreatectomy
Randomized Controlled Trials
Multicenter Studies
Pancreas
Morbidity

Keywords

  • Distal pancreatectomy
  • Postoperative pancreatic fistula
  • SEAMGUARD
  • TissueLink

ASJC Scopus subject areas

  • Surgery

Cite this

A multicenter randomized controlled trial comparing pancreatic leaks after TissueLink versus SEAMGUARD after distal pancreatectomy (PLATS) NCT01051856. / Shubert, Christopher R.; Ferrone, Christina R.; Fernandez-del Castillo, Carlos; Kendrick, Michael L.; Farnell, Michael B.; Smoot, Rory; Truty, Mark; Que, Florencia.

In: Journal of Surgical Research, Vol. 206, No. 1, 01.11.2016, p. 32-40.

Research output: Contribution to journalArticle

Shubert, Christopher R. ; Ferrone, Christina R. ; Fernandez-del Castillo, Carlos ; Kendrick, Michael L. ; Farnell, Michael B. ; Smoot, Rory ; Truty, Mark ; Que, Florencia. / A multicenter randomized controlled trial comparing pancreatic leaks after TissueLink versus SEAMGUARD after distal pancreatectomy (PLATS) NCT01051856. In: Journal of Surgical Research. 2016 ; Vol. 206, No. 1. pp. 32-40.
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abstract = "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.",
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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.

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