Pancreatic Fistula Clinical Trial
Official title:
Tri Stapler vs. Ultrasonic Scalpel in Distal Pancreatectomy
Several systematic reviews have investigated the management of the pancreatic stump in order
to reduce the postoperative pancreatic fistula (POPF) rate after distal pancreatectomy (DP).
The appropriate closure technique of the pancreatic stump is still debated. There is no
published experience about the comparison of the Endo GIA Reinforced Reload with Tri-Staple
Technology (TS) versus Harmonic Focus (US) after distal pancreatectomy (DP) regarding the
reduction of POPF.
The investigators want to compare the incidence of clinically-relevant POPF (CR-POPF) after
DP, depending upon the transection technique (TS versus US).
This is a randomized controlled, multicenter, patient-blinded, superiority trial. This
protocol was designed according to the SPIRIT guidelines.
Two groups of 76 patients (152 in total) with an indication for elective minimally invasive
or open DP for a lesion of the body-tail of the pancreas. The two techniques analyzed are
Endo GIA Reinforced Reload with Tri-Staple Technology (TS) and Harmonic Focus (US) as
control.
The primary endpoint is to evaluate the incidence of CR-POPF rate after DP. Secondary
endpoints are intraoperative outcomes (blood loss, operative time and conversion of the
minimally invasive procedure), postoperative outcomes (complications rate; hospitalization
parameters to 90 days; mortality) and treatment costs.
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