Dissection with LigaSure Impact™ versus conventional resection in pylorus-preserving partial pancreatoduodenectomy (DISSECT): a single-institution randomized controlled trial.

ABSTRACT

PURPOSE: In partial pancreatoduodenectomy, appropriate effective hemostasis during dissection is of major importance for procedural flow, operation time, and postoperative outcome. As ligation, clipping, or suturing of blood vessels is time-consuming and numerous instrument changes are required, the primary aim of this randomized controlled trial was to assess whether LigaSure Impact™ exhibits benefits over named conventional dissection techniques in patients undergoing pylorus-preserving partial pancreatoduodenectomy. METHODS: This single-institution, randomized, superiority trial was performed between September 27, 2009, and February 24, 2012. Patients undergoing pylorus-preserving partial pancreatoduodenectomy were allocated to the study arms in a 11 ratio based on an unstratified block randomization with random block sizes to receive either dissection with LigaSure Impact™ or conventional dissection. The primary endpoint was operation time. Secondary endpoints included peri- and postoperative morbidity and mortality, intraoperative blood loss, and length of hospital stay. To observe a time reduction of 40 min, 51 patients per arm were required. The primary analysis was the intention to treat. RESULTS: The mean operation time did not differ between the Ligasure Impact™ (308 min; SD 56 min; range 155-455 min) and the conventional dissection (318 min; SD 90 min, range 175-550 min) (p = 0.531). Moreover, LigaSure Impact™ dissection did not show significant advantages over conventional dissection in terms of peri- and postoperative morbidity and mortality, intraoperative blood loss, or length of hospital stay. CONCLUSIONS: The application of LigaSure Impact™ dissection in pylorus-preserving partial pancreatoduodenectomy does not increase effectiveness and safety of dissection. TRIAL REGISTRATION DRKS00000166.