NCT03880773

Comparison Between Two Methods of Pancreatic Transection in Distal Pancreatectomy

Tri Stapler vs. Ultrasonic Scalpel in Distal Pancreatectomy

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 152 (estimated)
• Sponsor: Azienda Ospedaliera Universitaria Integrata Verona · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Pancreatic Fistula
• Distal Pancreatectomy

Interventions

Type	Name	Description
DEVICE	Stapler	for transection of the pancreas and pancreatic stump treatment
DEVICE	ultrasonic shears	for transection of the pancreas and pancreatic stump treatment

Timeline

• Start date: 2018-07-01
• Primary completion: 2020-12-31
• Completion: 2020-12-31
• First posted: 2019-03-19
• Last updated: 2019-03-19

Locations

1 site across 1 country: Italy